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

Athletic Greens

Status: Completed

Conditions: Nutrition, Healthy; Healthy Aging; Gastrointestinal Microbiome

Treatments: Dietary Supplement: Placebo; Dietary Supplement: AG1 - Nutritional Supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT06332898

AG-01-0324

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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105 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Maltodextrin + Flavoring

Treatment:

Dietary Supplement: Placebo

AG1 - Nutritional Supplement

Experimental group

Description:

AG1, a foundational nutritional supplement

Treatment:

Dietary Supplement: AG1 - Nutritional Supplement