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New meta-analyses, RCTs and systematic reviews that we monitor daily in PubMed. Independently indexed, not editorially curated.
Nutrition and cancer · 2026
Radiotherapy for prostate cancer often leads to gastrointestinal toxicity, weight gain, fatigue, and reduced quality of life. Nutrition and lifestyle interventions are increasingly used in cancer care, yet evidence specific to men receiving radiotherapy remains limited. We systematically searched PubMed, Embase, Web of Science, and the Cochrane Library to June 2025 for studies evaluating nutrition and lifestyle interventions in adults undergoing radiotherapy for prostate cancer. Study quality was assessed using the Cochrane Risk of Bias tool, Newcastle-Ottawa Scale, and ROBINS-I. Nineteen studies were included. In radiotherapy-specific trials, individualized nutrition interventions showed potential to attenuate weight gain and manage gastrointestinal symptoms, while restrictive dietary modifications alleviated bowel complaints but were associated with declines in energy intake and nutritional status. Tomato-juice supplementation increased lycopene levels without consistent clinical benefit. In mixed-modality cohorts, dietary modifications were associated with meaningful weight loss and favorable changes in triglycerides, HDL, and HbA1c. Comprehensive lifestyle programs improved psychological distress, urinary symptoms, and quality of life. Nutrition and lifestyle interventions show promising signals for improving weight control, symptoms, metabolic profiles, and quality of life during radiotherapy. Given the heterogeneity of evidence, more robust, radiotherapy-specific randomized trials with standardized endpoints are needed to confirm efficacy.
Molecular nutrition & food research · 2026
Chronic, low-grade inflammation is a hallmark of many noncommunicable diseases. Diets enriched with tomatoes and soy are associated with better health outcomes in inflammation-related illnesses, with lycopene and isoflavones considered key bioactive components, respectively. On the basis that whole food combinations may exert greater effects than isolated phytochemicals, we examine the anti-inflammatory and metabolic effects of tomato-soy juice compared to a low carotenoid tomato juice control in obesity. Twelve healthy adults with obesity were provided either tomato-soy juice (54 mg lycopene/d, 189.9 mg isoflavones/d) or a low carotenoid tomato juice (no isoflavones) daily for 4 weeks, then crossed over to the other treatment following a washout period. Plasma carotenoids, cytokines, and the urine metabolome were measured pre- and post-interventions. Plasma lycopene significantly increased by 2.48-fold after tomato-soy intake. IL-5, IL-12p70, and GM-CSF significantly decreased (p < 0.05), and TNF-α trended downward (p = 0.052) following tomato-soy. Soy isoflavone metabolites primarily distinguished post-tomato-soy urine profiles. Both interventions induced some shared metabolomic changes in the urine, indicating tomato-driven effects independent of lycopene. Overall, tomato-soy intake reduced pro-inflammatory cytokines and altered urine metabolomic profiles in obesity, supporting future studies using this functional food product for other inflammation-related conditions.
Ophthalmology · 2025
To determine whether oral micronutrient supplementation slows geographic atrophy (GA) progression in age-related macular degeneration (AMD). Post hoc analysis of Age-Related Eye Disease Study (AREDS) and AREDS2, multicenter randomized placebo-controlled trials of oral micronutrient supplementation, each with 2 × 2 factorial design. A total of 392 eyes (318 participants) with GA in AREDS and 1210 eyes (891 participants) with GA in AREDS2. The AREDS participants were randomly assigned to oral antioxidants (500 mg vitamin C, 400 IU vitamin E, 15 mg β-carotene), 80 mg zinc, combination, or placebo. The AREDS2 participants were randomly assigned to 10 mg lutein/2 mg zeaxanthin, 350 mg docosahexaenoic acid/650 mg eicosapentaenoic acid, combination, or placebo. Consenting AREDS2 participants were also randomly assigned to alternative AREDS formulations: original; no beta-carotene; 25 mg zinc instead of 80 mg; both. (1) Change in GA proximity to central macula over time and (2) change in square root GA area over time, each measured from color fundus photographs at annual visits and analyzed by mixed-model regression according to randomized assignments. In AREDS eyes with noncentral GA (n = 208), proximity-based progression toward the central macula was significantly slower with randomization to antioxidants versus none, at 50.7 μm/year (95% confidence interval [CI], 38.0-63.4 μm/year) versus 72.9 μm/year (95% CI, 61.3-84.5 μm/year; P = 0.012), respectively. In AREDS2 eyes with noncentral GA, in participants assigned to AREDS antioxidants without β-carotene (n = 325 eyes), proximity-based progression was significantly slower with randomization to lutein/zeaxanthin versus none, at 80.1 μm/year (95% CI, 60.9-99.3 μm/year) versus 114.4 μm/year (95% CI, 96.2-132.7 μm/year; P = 0.011), respectively. In AREDS eyes with any GA (n = 392), area-based progression was not significantly different with randomization to antioxidants versus none (P = 0.63). In AREDS2 eyes with any GA, in participants assigned to AREDS antioxidants without β-carotene (n = 505 eyes), area-based progression was not significantly different with randomization to lutein/zeaxanthin versus none (P = 0.64). Oral micronutrient supplementation slowed GA progression toward the central macula, likely by augmenting the natural phenomenon of foveal sparing. Proprietary or commercial disclosure may be found after the references.
Food & function · 2024
Background: due to the high incidence of liver disease and the severity of adverse outcomes, liver disease has become a serious public health problem, bringing a huge disease burden to individuals, families, and society. Most studies have shown significant differences in serum carotenoid content and dietary carotenoid intake between liver disease patients and non-liver disease patients, but some studies have reported contrary results. This paper aimed to systematically review and analyze all published epidemiological studies on carotenoids and liver disease to quantitatively assess the relationship between serum and dietary carotenoid concentrations and liver disease. Methods: by systematically searching PubMed, Web of Science, Scopus, Embase, and Cochrane databases according to pre-combined search terms from inception to July 23, 2024, 30 studies were found to meet the exclusion criteria. Finally, 3 RCT studies, 6 cohort studies, 11 case-control studies, 9 cross-sectional studies, and 1 RCT-combined cross-sectional study were included in the further analysis. Two reviewers independently scored the literature quality and extracted data, and the results were represented by the standard mean difference (SMD) with a 95% confidence interval. Cochran Q statistics and I2 statistics were used to evaluate statistical heterogeneity (defined as significant when P < 0.05 or I2 > 50%). When there was insignificant heterogeneity, a fixed effects model was selected; otherwise a random effects model was used. Publication bias was assessed by the Egger test. Results: pooled meta-analysis showed that serum α-carotene (SMD = -0.58, 95% CI (-0.83, -0.32), P < 0.001), β-carotene (SMD = -0.81, 95% CI (-1.13, -0.49), P < 0.001), and lycopene (SMD = -1.06, 95% CI (-1.74, -0.38), P < 0.001) were negatively correlated with the risk and severity of liver disease. However, no significant difference was observed between serum β-cryptoxanthin (SMD = 0.02, 95% CI (-0.41, 0.45), P = 0.92) and lutein/zeaxanthin (SMD = 0.62, 95% CI (-1.20, 2.45), P = 0.502). Dietary β-carotene intake (SMD = -0.22, 95% CI (-0.31, -0.13), P < 0.001) was negatively associated with the risk of liver disease. The Egger test showed no publication bias (P > 0.05). An intake of more than 6 mg of carotenoids on an energy-restricted diet can effectively alleviate the symptoms of NAFLD. Conclusion: lower serum concentrations of α-carotene, β-carotene, and lycopene were associated with a higher risk of liver disease. Meanwhile, dietary intake of β-carotene could reduce the incidence of liver disease. However, for malignant diseases such as liver cancer, it did not show the significant effects of carotenoid supplementation.
The Journal of nutrition · 2025
Pistachios are a bioavailable source of the xanthophyll lutein. Along with zeaxanthin, these plant pigments are major components of macular pigment (MP) in the human retina. MP can be non-invasively measured and is referred to as MP optical density (MPOD). MPOD is modifiable with dietary interventions that include lutein and zeaxanthin (L/Z). Higher MPOD protects the eye from light damage and is positively associated with eye health. This dietary intervention study aimed to evaluate the effect of pistachio consumption on MPOD. This single-blinded, randomized controlled trial compared a 12-week pistachio intervention (2 oz/d) with usual diet (UD) on MPOD and serum L/Z in middle-aged to older healthy adults (n = 36) in a 1:1 randomization scheme. Participants were selected for habitually low L/Z intake and low baseline MPOD. MPOD was measured using heterochromatic flicker photometry at 4 retinal eccentricities during baseline, week 6, and week 12 study visits. Serum L/Z was analyzed using high-performance liquid chromatography. Primary statistical analysis was conducted on an intent-to-treat basis using repeated-measure analysis of variance. Compared with UD, MPOD of the participants in the pistachio intervention group (PIS) had significantly increased (P < 0.001) at all eccentricities over the initial 6-wk period. This increase was maintained at week 12. MPOD in the UD participants did not change during the 12-week period. Serum lutein concentration followed a similar pattern to MPOD; serum cis-lutein and zeaxanthin did not change in either group over the 12-wk intervention. The results of our study demonstrate that a dietary intervention with pistachios is efficacious in increasing MPOD in healthy adults selected for habitually low intake of L/Z and low baseline MPOD. This suggests that pistachio consumption could be an effective dietary strategy for preserving eye health. Future studies need to evaluate the generalizability of our findings to other populations. This trial was registered at clinicaltrials.gov as NCT05283941.
Hormone molecular biology and clinical investigation · 2025
Neurodegenerative diseases are defined by specific protein accumulation and anatomic vulnerability leading to neuronal loss. Some studies have shown that lutein may have an effect on neurodegenerative diseases. As most of the neurodegenerative diseases don't have certain cure and therapies focus on symptom control, Lutein may be a complementary treatment. Due to controversies in studies investigating lutein effect on neurodegenerative diseases, we decided to perform a systematic review on these studies. A systematic search was carried out in the available databases. We used all MeSH terms and relevant keywords. Studies that reported relationship between lutein and any neurodegenerative disease were included. We found 278 studies. After removing duplicates, screening by titles and abstracts and excluding irrelevant papers, 17 articles were included in this study. Fourteen studies investigated Alzheimer's disease, 2 studies Parkinson's disease and 1 study Amyotrophic lateral sclerosis. 1/17 study found that high serum levels of lutein at baseline were associated with a lower risk of AD mortality and lutein effect on lipid profile have been investigated in 2/17 studies. Also, 1/17 study has been shown that high intake of lutein may reduce the risk of ALS progression. 4/17 studies confirm that lutein can improve cognitive function. 8/17 studies demonstrate a reduction in the progression of AD, and 2/17 studies indicate an improvement in lipid profiles. However, some studies did not find any significant associations. Additionally, there is a limited number of studies investigating the effects of lutein on other neurodegenerative diseases.
Nutrients · 2024
Background/Objectives: Age-related macular degeneration (AMD) is a leading cause of visual impairment in the elderly and is characterized by a multifactorial etiology. Emerging evidence points to the potential involvement of the gut-retina axis in AMD pathogenesis, prompting exploration into novel therapeutic strategies. This study aims to investigate the effects of some micronutrients (such as lutein and zeaxanthin) and saffron (as a supplement)-known for their anti-inflammatory properties-on ophthalmological and microbial parameters in neovascular AMD (nAMD) patients. Methods: Thirty naive nAMD patients were randomized to receive daily micronutrient supplementation alongside anti-VEGF (vascular endothelial growth factor) therapy, or anti-VEGF treatment alone, over a 6-month period, with comparisons made to a healthy control (HC) group (N = 15). Ophthalmological assessments, biochemical measurements, and stool samples were obtained before and after treatment. Gut microbiota (GM) characterization was performed using 16S rRNA sequencing, while short-chain fatty acids (SCFAs), medium-chain fatty acids (MCFAs), and long-chain fatty acids (LCFAs) were analyzed with a gas chromatography-mass spectrometry protocol. Results: Compared to HC, nAMD patients exhibited reduced GM alpha diversity, altered taxonomic composition, and decreased total SCFA levels, in addition to elevated levels of proinflammatory octanoic and nonanoic acids. Micronutrient supplementation was associated with improved visual acuity relative to the group treated with anti-VEGF alone, along with a decrease in the total amount of MCFAs, which are metabolites known to have adverse ocular effects. Conclusions: In conclusion, despite certain limitations-such as the limited sample size and the low taxonomic resolution of 16S rRNA sequencing-this study highlights compositional and functional imbalances in the GM of nAMD patients and demonstrates that micronutrient supplementation may help restore the gut-retina axis. These findings suggest the therapeutic potential of micronutrients in enhancing ocular outcomes for nAMD patients, underscoring the complex interaction between GM and ocular health.
Food & function · 2025
Central obesity poses a significant health threat. Lutein-rich fruits and vegetables may help manage obesity. Limited evidence suggests that lutein exerts health effects by inhibiting advanced glycation end products (AGEs), but data on its effects in centrally obese individuals are sparse. Thus, we aimed to investigate the effects of lutein supplementation in subjects with central obesity. A double-blind, randomized controlled trial was conducted involving patients with central obesity. Anthropometric indices, dietary intake, metabolic parameters, carotenoid and AGEs levels were compared between those receiving a 32-week intervention of 10 mg d-1 lutein and a placebo group. There were 117 patients randomly assigned in the analysis. Twenty-three patients were lost to follow-up. Both intention-to-treat analysis and the per-protocol analysis showed significant reductions in plasma total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, and malonaldehyde levels in the lutein supplementation group compared with the placebo group. Significant differences were also observed between the groups in plasma lutein, carboxyethyl lysine (CEL), carboxymethyl lysine (CML), methylglyoxal hydroimidazolone (MG-HI) levels and skin carotenoid index (all P < 0.05). The mean difference and 95% confidence interval were 0.12 [0.08 to 0.16] μg ml-1, -8.76 [-16.60 to -0.89] ng ml-1, -72.3 [-134.0 to -10.9] ng ml-1, -233.9 [-429.0 to -36.8] ng ml-1 and 0.94 [0.56 to 1.31] a.u., respectively. Furthermore, changes in plasma lutein concentration were positively correlated with changes in the skin carotenoid index (r = 0.41, P < 0.001), and negatively correlated with changes in plasma CEL (r = -0.24, P = 0.018), (CML) (r = -0.21, P = 0.051, and MG-H1) (r = -0.25, P = 0.017). In conclusion, regular lutein intake can improve metabolic health in adults with central obesity by increasing plasma lutein concentrations, reducing oxidative stress, lowering plasma TC, LDL-C, and ApoB levels, and downregulating AGEs.
International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition · 2024
Dry Eye Disease (DED) significantly impacts global populations, causing discomfort and vision problems. This review explores the effects of lutein supplementation on DED symptoms and signs. A systematic review was conducted following PRISMA guidelines, examining clinical trials from databases including PubMed, Web of Science, EMBASE, and the Cochrane Library. Six randomized controlled trials (RCTs) involving 584 subjects were included. Meta-analysis was not conducted due to heterogeneity in study designs, dosages, and outcome measures. Lutein dosages ranged from 3 mg/day to 20 mg/day, with treatment durations from 4 to 12 weeks. Improvements were observed in subjective symptoms, with significant reductions in Ocular Surface Disease Index (OSDI) scores in some studies. Objective measures also showed positive results: tear break-up time (TBUT) increased significantly in some trials. However, other studies reported no significant differences between treatment and control groups, reflecting heterogeneity in outcomes. Schirmer's test and corneal-conjunctival staining results varied, with some showing significant improvements and others not. Lutein supplementation may benefit DED patients by improving symptoms and tear film stability. However, due to study heterogeneity, larger, well-designed RCTs are needed to establish standardized dosing and confirm these findings.
The Cochrane database of systematic reviews · 2025
Lutein and zeaxanthin are nutrients with antioxidant properties found in the macula of the eye and brain tissue. They have been reported to play a role in reducing oxidative damage, especially in the eyes and possibly in other organ systems. Oxygen free radicals are one of the agents postulated to cause tissue damage in preterm infants, which leads to morbidities such as retinopathy of prematurity (ROP), intraventricular haemorrhage (IVH), and necrotising enterocolitis (NEC). Supplementation with lutein and zeaxanthin may reduce oxidative damage, hence reducing morbidity and mortality in preterm infants. To assess the effectiveness of lutein and zeaxanthin supplementation in reducing morbidity and mortality in preterm infants. We conducted searches up to 17 December 2024 in CENTRAL, MEDLINE, Embase, and two trial registries. We also searched the reference lists of included studies, and related reviews and studies. We included randomised controlled trials (RCTs), cluster-RCT, cross-over trials, and quasi-RCTs that compared lutein and zeaxanthin supplementation against placebo or no supplementation for preterm infants less than 37 completed weeks' postmenstrual age. We used standard Cochrane methods. Our primary outcomes were the incidence of any stage of ROP, incidence of ROP stage 3 and above, incidence of visual impairment, and mortality assessed throughout the neonatal intensive care unit (NICU) stay. Secondary outcomes included the incidence of IVH, incidence of NEC, and any reported adverse effects. We used GRADE to assess the certainty of the evidence. We included five studies (666 preterm infants) that compared lutein and zeaxanthin supplementation versus control (placebo or no supplementation). All five studies were conducted in high-income countries (Italy and the USA). We did not find any studies comparing lutein or zeaxanthin separately versus placebo or no supplementation. Most of the studies had a low risk of bias in most key domains, such as allocation concealment and blinding. The evidence suggests that lutein and zeaxanthin supplementation probably has little or no effect on ROP (any stage) when comparing infants who received lutein and zeaxanthin supplementation with those who did not (risk ratio (RR) 0.90, 95% confidence interval (CI) 0.66 to 1.24; P = 0.53; I2 = 0%; 4 studies, 532 infants; moderate-certainty evidence). Lutein and zeaxanthin supplementation probably reduces the incidence of ROP stage 3 and above (RR 0.49, 95% CI 0.29 to 0.81; P = 0.005; I2 = 0%; 4 studies, 532 infants; moderate-certainty evidence). No studies assessed the incidence of visual impairment. Lutein and zeaxanthin supplementation may have little or no effect on mortality assessed throughout the NICU stay (RR 0.95, 95% CI 0.42 to 2.17; P = 0.91; I2 = 0%; 4 studies, 470 infants; low-certainty evidence), incidence of IVH (all grades) (RR 0.87, 95% CI 0.44 to 1.75; P = 0.70; I2 = 0%; 4 studies, 483 infants; low-certainty evidence), and incidence of NEC: Bell's stage II or greater (RR 0.87, 95% CI 0.43 to 1.76; P = 0.71; I2 = 0%; 5 studies, 666 infants; low-certainty evidence). No adverse effects were reported in either group. While supplementation with lutein and zeaxanthin from day one of life in preterm infants until discharge probably reduces the incidence of ROP stage 3 and above, it may have little or no effect on the incidence of ROP at any stage, IVH or NEC, or mortality assessed throughout the NICU stay. However, the pooled estimates for these outcomes may change with further rigorously conducted trials. There were no adverse effects reported.
Clinical nutrition ESPEN · 2025
Neuroprotective nutrients including omega 3 fatty acid docosahexaenoic acid (DHA), choline, and carotenoids play an important role in infant brain structure and function; however, the effects of maternal nutrition on the infant brain are understudied. We leveraged data from our large randomized clinical trial among pregnant women to determine whether maternal nutrients including DHA, choline, lutein/zeaxanthin (L/Z) and egg intake (a food source of these nutrients) were related to infant brain function. Data from n = 241 maternal and infant dyads were included in this secondary analysis. Food frequency questionnaires (Diet History Questionnaire II) at 32 weeks' gestation were used to assess choline and carotenoid intake and a brief survey on egg consumption (# eggs consumed per week) was used to assess egg intake. Maternal red blood cell DHA status was measured at 32 weeks' gestation. Infant brain function was measured using high density electroencephalogram (EEG) to auditory (1 month of age) and visual (6 months of age) event-related potentials (ERP). At 1 month of age, maternal DHA status was associated with greater delta-band spectral power to the novel tone during the ERP. Choline, choline∗L/Z, L/Z∗DHA, and choline∗L/Z∗DHA were each related to power to the frequent tone during the ERP. At 6 months, choline, DHA status, and choline∗DHA were related to shorter latency to the novel visual stimulus. Choline∗L/Z and choline∗L/Z∗DHA were related to greater amplitude to the novel stimulus. Overall, maternal neuroprotective nutrients were related to several markers of infant brain function.
Journal of medicinal food · 2025
This study was conducted to evaluate and verify the improved bioavailability, as determined by the plasma concentrations of lutein and zeaxanthin, of the test supplement, XanMax® 2002 plus LuZeAbility™, as compared to the reference supplement, XanMax® 2002. For this purpose, this study was designed as a randomized, double-blind, two-group, two-period cross-over clinical trial research. A total of 24 male subjects participated in the clinical trial. They were randomized 1:1 into group 1 or 2 to consume two types of supplements in two separate periods. This study aimed to propose and demonstrate that the bioavailability and the plasma concentrations of lutein and zeaxanthin in the test supplement were significantly higher (110-132.8%) than in the reference supplement in all consecutive periods, such as 12 to 72 h after intake and at the time of maximum concentration. These results are expected to strengthen macular pigment optical density levels, ultimately providing a safe and effective intervention for comprehensively promoting eye health. Therefore, the findings of this study have significant pharmacokinetic implications and offer valid theoretical and practical insights for both academic research and the industrial development in the supplement market.
The American journal of clinical nutrition · 2025
Alzheimer disease (AD) prevention is a public health priority, yet the impact of dietary carotenoids on cognitive decline, particularly in apolipoprotein E (APOE) ε4 carriers, remains unclear. The objective of this study was to examine whether the APOE ε4 genotype modifies the relationship between blood carotenoid concentrations and global cognition. This study was conducted within the Mediterranean-Dietary Approaches to Stop Hypertension intervention for neurodegenerative delay trial, a 3-y randomized controlled trial comparing the effects of the Mediterranean-Dietary Approaches to Stop Hypertension intervention for neurodegenerative delay diet with the usual diet on global cognition in older adults. Eligible participants were ≥65 y, had a body mass index (in kg/m2) >25, a family history of AD, suboptimal diets, and a Montreal cognitive assessment score ≥22. The primary outcome was 3-y change in global cognitive function, assessed using a validated composite cognitive score converted to standardized units (SUs). Baseline plasma carotenoid concentrations were measured in a subgroup of participants (n = 442). Mixed-effects models were used to test the interaction between APOE ε4 status and baseline carotenoid concentrations on cognitive trajectories. The mean age was 70.0 y for noncarriers (n = 308) and 69.4 y for APOE ε4 carriers (n = 134). Among APOE ε4 carriers, a 1-unit increment in plasma total carotenoids at baseline was associated with higher global cognitive scores [β = 0.17 SU; 95% confidence interval (CI): 0.06, 0.28 SU; P = 0.009]. Similar associations were observed for β-carotene (β = 0.13 SU; 95% CI: 0.05, 0.21 SU; P = 0.001), α-carotene (β = 0.09 SU; 95% CI: 0.02, 0.15 SU; P = 0.008), lutein plus zeaxanthin (β = 0.14 SU; 95% CI: 0.04, 0.25 SU; P = 0.008), lycopene (β = 0.17 SU; 95% CI: 0.07, 0.28 SU; P = 0.005), and β-cryptoxanthin (β = 0.13 SU; 95% CI: 0.05, 0.21 SU; P = 0.03). Associations in noncarriers were weaker or nonsignificant. Higher plasma carotenoid concentrations were associated with slower cognitive decline in APOE ε4 carriers, potentially mitigating genetic risk. This trial was registered at clinicaltrials.gov as NCT02817074.
Translational vision science & technology · 2025
To assess the effect of a six-month lutein ester supplementation on children's choroidal thickness (CT). This double-blind, randomized controlled trial recruited 180 children aged eight to twelve years in a school from April to May 2021. The follow-up was completed in November 2021. Participants were randomly assigned to the treatment group (n = 90, one sachet with 8 mg lutein ester) or the control group (n = 90, one placebo sachet). Each participant consumed one sachet daily orally for six months. Primary outcomes were between-group differences in changes in CT at six-month follow-up visits. The six-month mean subfoveal CT decrease was 1.16 (-3.32 to 5.63) µm for the treatment group and -8.92 (-13.43 to -4.41) µm for the control group, with a mean difference of 10.08 µm (95% confidence interval [CI], 3.68 to 16.47, P = 0.002, corrected P = 0.018). The six-month mean temporal 1 mm and temporal 1.5 mm CTs decrease were -2.83 (-9.63 to 3.96) µm and -1.24 (-9.64 to 7.15) µm for the treatment group and -16.76 (-24.20 to -9.33) µm and -15.77 (-22.67 to -8.88) µm for the control group, with mean differences of 13.93 µm (95% CI, 3.79-24.07, P = 0.007, corrected P = 0.030) and 14.53 µm (95% CI, 3.59-25.47, P = 0.010, corrected P = 0.030), respectively. The two groups were not significantly different in the other grids (all P > 0.05). Six-month lutein ester supplementation could effectively mitigate subfoveal and temporal choroidal thinning. Given lutein's favorable safety, affordability, and global availability, our study highlights its untapped potential as a promising, adjunctive nutritional strategy to support clinical efforts in myopia prevention and management.
PloS one · 2025
Two infant formulas with unique combinations of 1,3-dioleoyl-2-palmitoyl-sn-glycerol sn2 palmitate, galactooligosaccharide, polydextrose, fructooligosaccharide, β-carotene, lutein, α-lactalbumin, osteopontin, and lactoferrin were evaluated for non-inferiority compared to a commercially available formula. In a randomized, controlled, parallel-arm, double-blind, multicenter, non-inferiority study, eligible infants were enrolled to receive an experimental (BBN-001 [Part 1; N = 129], BBN-102 [Part 2; N = 117]) formula or commercial formula (Brand; N = 143) for 120 days (Clinical Trials.gov NCT03331276). Infants were considered eligible if they were healthy, term (≥ 37 and ≤ 42 weeks of gestation), singleton newborns, with a birth weight of at least 2,500 g, and no more than 14 postnatal days-of-age. Anthropometric growth, formula intake, gastrointestinal tolerance, and adverse events were measured throughout the study, and fecal soap fatty acids were measured at the end. The primary endpoint was weight gain at the end of the trial, with treatment groups to be considered non-inferior if their weight gain was > -3 g/d compared to the control group. Both experimental formulas were non-inferior to the Brand formula according to anthropometric outcomes. Formula intake, total adverse events, and stool frequency and consistency were similar to Brand formulas. Some measures of gassiness and fussiness improved in the experimental formulas (P < 0.05). Fecal calcium increased and fecal palmitic acid soaps decreased in both experimental formulas (all P ≤ 0.045), and total soap fatty acids were decreased in the BBN-102 group compared to the Brand group (P = 0.020). The experimental formulas were well tolerated and deemed non-inferior to those of a Brand formula. The experimental formulas improved some measures of gastrointestinal tolerance compared to standard commercially available infant formulas. ClinicalTrials.gov NCT03331276.
Nutrients · 2026
Background/Objectives: Macular pigment optical density (MPOD) is a nutrition-responsive biomarker that indicates the antioxidant status of the macula. This study aimed to evaluate the effects of long-term supplementation with a standardized Centella asiatica (L.) Urb. extract (CA-HE50) on MPOD in a randomized, double-blind, placebo-controlled clinical trial. Methods: Eighty men and women aged 45-65 years, with baseline MPOD values between 0.2 and 0.4, were randomly assigned to receive either CA-HE50 (300 mg/day, n = 40) or a placebo (n = 40) for 6 months. Efficacy was assessed by measuring MPOD at baseline and on Days 60, 120, and 180. The primary efficacy endpoint was the change in MPOD from baseline to Day 180. Safety was evaluated through monitoring adverse events, vital signs, and clinical laboratory tests. Results: By Day 180, supplementation with CA-HE50 resulted in a statistically significant increase in MPOD compared to the placebo in the right eye, left eye, and the average of both eyes (all p < 0.001). Significant between-group differences were also observed at Day 120, indicating a time-dependent improvement in MPOD. Additionally, the proportion of responders was significantly higher in the CA-HE50 group compared to the placebo group (p < 0.001). CA-HE50 was well tolerated, with no serious adverse events or clinically relevant safety concerns identified during the intervention period. Conclusions: Long-term supplementation with C. asiatica extract significantly improved MPOD, supporting its potential role in enhancing macular nutritional status. These findings suggest that CA-HE50 may serve as a beneficial dietary intervention for maintaining macular health.
Journal of ethnopharmacology · 2024
Cordyceps sinensis (CS) is a fungus parasitic on lepidopteran larvae which is often used to treat lung diseases and regulate immune function. This review aimed to evaluate the efficacy of CS in the adjuvant treatment of lung cancer. As of June 2022, the electronic database search was conducted in PubMed, EMBASE, Cochrane Library, China Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), Wanfang Database and China Science Journal Database (VIP database). Randomized clinical trials (RCTs) that evaluated the efficacy of CS as an adjuvant treatment for lung cancer were included. After the quality evaluation, meta-analysis was performed with Stata 16.0 software. A total of 12 RCTs with 928 patients were identified for this meta-analysis, which showed that as an adjuvant treatment, CS has the following advantages in the treatment of lung cancer: (1) Improved tumor response rate (TRR) (RR: 1.17， 95%CI: 1.05-1.29，P = 0.00); (2) improved immune function, including increased CD4 (MD: 4.98, 95%CI: 1.49-8.47, P = 0.01), CD8 (MD: 1.60, 95%CI: 0.40-2.81, P = 0.01, I2 = 0.00%), NK (MD: 4.17, 95%CI: 2.26-6.08, P = 0.00), IgA (MD: 1.29, 95%CI: 0.35-2.24, P = 0.01), IgG (MD: 3.95, 95%CI: 0.98-6.92, P = 0.01) and IgM (MD: 6.44, 95%CI: 0.63-12.26, P = 0.03); (3) improved patients' quality of life based on the mean ± SD of Karnofsky Performance Status (KPS) (MD: 8.20, 95%CI: 6.87-9.53, P = 0.00); (4) reduced the incidence of adverse drug reactions (ADRs), including the incidence of myelosuppression (RR: 0.38, 95%CI: 0.19-0.75, P = 0.01), leukopenia (RR: 0.76, 95%CI: 0.63-0.92, P = 0.00), and thrombocytopenia (RR: 0.52, 95%CI: 0.31-0.86, P = 0.01) (5) reduced the incidence of radiation pneumonitis (RR: 0.74, 95%CI: 0.62-0.88, P = 0.00). However, the number of improved patients based on KPS (RR: 1.47, 95%CI: 0.98-2.20, P = 0.06) were similar between two groups, liver and renal damage (RR: 0.32, 95%CI: 0.09-1.10, P = 0.07) and gastrointestinal adverse reactions (RR: 0.80, 95%CI: 0.47-1.37, P = 0.42) as well. Subgroup analysis showed that CS could increase the TRR in the treatment with 6 g/d and 21 days/3-4 cycles. Compared with conventional treatment, adjuvant treatment with CS of lung cancer not only improve TRR, QOL and immune function, but also reduce the incidence of ADRs and radiation pneumonitis. The optimal usage may be 6 g/d and 21 days/3 to 4 cycles. CRD42022333681.
Nutrients · 2024
In the present study, we conducted a placebo-controlled, double-blind, parallel-group comparison trial in which an extract of Cordyceps militaris (CM) mycelium was administered to long-distance runners for 16 weeks during the pre-season training period and blood test markers for anemia were investigated. The results indicated that the change rates of serum ferritin levels were moderately increased in the CM group (n = 11) but decreased in the placebo group (n = 11) during the study period, and the levels were significantly increased in the CM group compared with those in the placebo group at 4 weeks and 8 weeks after the test food intake (p < 0.05). Moreover, the change rates of hemoglobin and hematocrit were significantly increased in the CM group compared with those in the placebo group at 8 weeks after the test food intake (p < 0.05). These observations suggest that the intake of test food containing Cordyceps militaris mycelium extract is expected to effectively maintain the hemoglobin and hematocrit levels in long-distance runners, possibly via the suppression of the decrease in iron storage, which is reflected by serum ferritin, during pre-season training. Furthermore, the levels of creatine kinase were increased above the normal range in both the placebo and CM groups at registration. Interestingly, the creatine kinase levels were significantly decreased in the CM group compared with those in the placebo group at 16 weeks after the test food intake (p < 0.05). These results suggest that Cordyceps militaris mycelium extract exhibits a protective action on the muscle damage observed in long-distance runners and may suppress muscle injury. Together, these observations suggest that Cordyceps militaris mycelium extract exhibits an improving effect on the markers for not only anemia, but also muscle injury in long-distance runners during pre-season training.
Pharmaceutical biology · 2024
Bailing capsule, derived from Cordyceps sinensis (Berk.) Sacc. (Clavicipitaceae), has shown potential in the treatment of chronic obstructive pulmonary disease (COPD), a prevalent respiratory disorder. This study elucidates the efficacy and mechanism of action of the use of Bailing capsules in the treatment of COPD using meta-analysis and network pharmacology. A meta-analysis of randomized controlled trials (RCTs) was performed. The treatment group received Bailing capsules alongside standard therapy, while the control group received standard therapy or in combination with other traditional Chinese medicines. Efficacy outcomes included lung function, exercise tolerance, acute exacerbation risk, and quality of life. Network pharmacology and molecular docking identified key targets of Bailing capsules. The meta-analysis of 27 RCTs showed significant improvements in the treatment group for forced expiratory volume in 1 s (FEV1), FEV1/FVC ratio, and the 6-min walk test (6MWT). Additionally, there was a marked reduction in acute COPD attacks and an improvement in quality of life. Meanwhile, network pharmacological analysis identified SRC, HIF1A, NFKB1, HDAC2, and PRKACA, as the potential core targets for Bailing capsules in the treatment of COPD. Bailing capsules have shown promising results in the treatment of stable COPD. Future studies should focus on large-scale, multicenter RCTs to confirm the long-term benefits and safety of Bailing capsules.
International journal of biological macromolecules · 2024
Cordyceps sinensis (Berk.) Sacc. (Ophiocordyceps sinensis) is an edible and medicinal fungus used as a natural superior tonic. It is considered as scarce fungus with a high market demand. Therefore, as an alternative, fermentation technology has been proposed to produce artificial cordyceps (fermented C. sinensis) to address the shortage of cordyceps resources for industrialization and commercial utilization. Numerous studies have proved that polysaccharides are the important bioactive substances in the fermented C. sinensis, but the research data lack systematic review. In this review, current relevant research data regarding the preparation (including extraction, fractionation, and purification), structural characterization (including molecular weight, monosaccharide composition, glycosidic bond type, structural and conformational features), bioactivities, structure-activity relationships (SAR) and applications of polysaccharides from different sources of fermented C. sinensis last decade were analyzed and discussed. The findings highlight that the most commonly employed methods for preparing fermented Cordyceps sinensis polysaccharides (FCSPs) involve water extraction and alcohol precipitation, combing with sophisticated chromatographic techniques such as ion exchange and gel permeation chromatography. From these processes, 34 different polysaccharides were identified including 5 glucans and 7 heteropolysaccharides that were thoroughly characterized. FCSPs exhibited a broad spectrum of biological activities, ranging from antioxidant and renal protective effects to immunomodulatory, antitumor, and hypolipidemic properties. The structure-activity relationships (SAR) demonstrated that key factors, such as molecular weight, monosaccharide composition and glucosidic bond types, play critical roles in determining the bioactivity of FCSPs. Nevertheless, there remain unknown elements that continue to influence SAR, leaving room for further exploration. Furthermore, the limitation of existing studies and some new perspectives for future investigations on FCSPs were proposed.