The Effects of a Nutritional Supplement on Nutrient Status and Quality of Life

Completed · Not applicable · Has a placebo group

Conditions studied: Nutrition, Healthy, Gastrointestinal Microbiome, Healthy Aging

In brief

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.

Key facts

Study ID

NCT06332898

Run by

Athletic Greens International

People needed

105

Starts

2024-03-31

Expected to finish

2025-02-04

Last updated by the study team

2025-05-04

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Citruslabs — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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