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

NCT ID: NCT06332898

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2025-02-04

Brief Summary

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.

Conditions

Nutrition, Healthy; Gastrointestinal Microbiome; Healthy Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Maltodextrin + Flavoring

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin placebo

AG1 - Nutritional Supplement

AG1, a foundational nutritional supplement

Group Type: EXPERIMENTAL

AG1 - Nutritional Supplement

Intervention Type: DIETARY_SUPPLEMENT

A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients

Interventions

AG1 - Nutritional Supplement

A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Maltodextrin placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Athletic Greens International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellen O'Gorman

Role: PRINCIPAL_INVESTIGATOR

Citruslabs

Locations

Citruslabs

Santa Monica, California, United States

Countries

United States

Other Identifiers

AG-01-0324

Identifier Type: -

Identifier Source: org_study_id