NCT06332898已完成不适用
The Effects of a Nutritional Supplement on Nutrient Status and Quality of Life
Athletic Greens International2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2024年3月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Folate
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled study of N=120 apparently healthy men and women. The purpose of this study is to assess the effect of a novel dietary supplement on blood markers of nutrient status, gut microbiome, and overall quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide voluntary signed and dated informed consent.
- •No known history of chronic illness or disease.
- •Aged between 18 and 59.9 years (inclusive).
- •Body Mass Index of 20-34.9 (inclusive).
- •Willing to duplicate their previous 24-hour diet, refrain from caffeine and exercise for 24 hours, and fast for 10 hours prior to each Quest visit.
- •Agree to maintain existing dietary and physical activity patterns throughout the study period.
- •Willing and able to comply with the study protocol.
排除标准
- •History of unstable or new-onset cardiovascular, liver, or renal conditions.
- •History of diabetes or endocrine disorder.
- •Multivitamin/Multimineral supplement consumption within the past 3 months.
- •Regular consumption (i.e., at least five days/week) of resveratrol, quercetin, pterostilbene, coQ10, grapefruit, nicotinamide riboside, probiotics, prebiotic fiber, green tea, niacin (vitamin B3), or products meant to promote "healthy aging" or "anti-aging" or "longevity" in the 2 months prior to screening as well as throughout the study.
- •Subjects who have received an antibiotic, antifungal, antiparasitic, or antiviral treatment within 90 days prior to study.
- •History of use of medications or dietary supplements known to confound the study or its endpoints.
- •Excessive alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months.
- •Current smokers or smoking within the past month.
- •History of hyperparathyroidism or an untreated thyroid condition.
- •History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- •Prior gastrointestinal bypass surgery (Lapband, etc.).
- •Other known gastrointestinal or metabolic conditions that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, IBS/IBD, diarrheal illnesses, history of colon resection, gastroparesis, Inborn errors of metabolism (such as PKU).
- •Chronic inflammatory condition (e.g., rheumatoid arthritis, Crohn's, ulcerative colitis, Lupus, HIV/AIDS, etc.).
- •Previous medical diagnosis of asthma, gout, or fibromyalgia.
- •Pregnant women, women trying to conceive, women less than 120 days postpartum, or nursing women.
- •A change in hormone therapy, including oral contraceptives, within 4 weeks prior to screening, or unwilling to maintain current hormone therapy/oral contraceptive use throughout the course of the study.
- •Known allergy or sensitivity to any ingredient in the test formulations as listed in the product label.
- •Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
- •>10% weight change in the last 6 months.
- •- Specific exclusion type diets like vegan, vegetarian, carnivore, paleo, atkins, ketogenic etc.
结局指标
主要结局
Folate
时间窗: 90 days
Circulating Serum Folate Concentrations (ng/mL)
Vitamin C
时间窗: 90 days
Serum Vitamin C Concentrations (
Homocysteine
时间窗: 90 days
Circulating Serum Homocysteine Concentrations (umol/L)
Vitamin B12
时间窗: 90 days
Circulating Serum Vitamin B12 Concentrations (pg/mL)
Gut Microbiome
时间窗: 90 days
Examine changes in the gut microbiome structure and function measured by shallow shotgun metagenomics. Examine enrichment of taxa and metabolic pathways in the gut microbiome as a result of dietary supplementation.
Zinc
时间窗: 90 days
Circulating Serum Zinc Concentrations (ug/dL)
Red Blood Cell Folate
时间窗: 90 days
Circulating Red Blood Cell Folate Concentrations (nmol/L)
次要结局
- Dietary habits(90 Days)
- Well-being(90 Days)
- Gastrointestinal Health(90 Days)
- Fatigue & energy(90 Days)
- Complete Metabolic Blood Panel(90 Days)
- Complete Blood Count(90 Days)
研究者
研究点 (2)
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