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

NCT06332898 | Completed

• 1 other identifier: AG-01-0324
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• Homocysteine

  Circulating Serum Homocysteine Concentrations (umol/L)

  90 days

• Vitamin B12

  Circulating Serum Vitamin B12 Concentrations (pg/mL)

  90 days

• Folate

  Circulating Serum Folate Concentrations (ng/mL)

  90 days

• Red Blood Cell Folate

  Circulating Red Blood Cell Folate Concentrations (nmol/L)

  90 days

• Zinc

  Circulating Serum Zinc Concentrations (ug/dL)

  90 days

• Vitamin C

  Serum Vitamin C Concentrations (

  90 days

• Gut Microbiome

  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.

  90 days

Secondary Outcomes (6)

• Dietary habits

  90 Days

• Gastrointestinal Health

  90 Days

• Fatigue & energy

  90 Days

• Well-being

  90 Days

• Complete Metabolic Blood Panel

  90 Days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Maltodextrin + Flavoring

Dietary Supplement: Placebo

AG1 - Nutritional Supplement

EXPERIMENTAL

AG1, a foundational nutritional supplement

Dietary Supplement: AG1 - Nutritional Supplement

Interventions

AG1 - Nutritional Supplement DIETARY_SUPPLEMENT

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

AG1 - Nutritional Supplement

Placebo DIETARY_SUPPLEMENT

Maltodextrin placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Athletic Greens International: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

Study Officials

• Ellen O'Gorman

  Citruslabs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo Controlled Design

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: March 31, 2024
• Primary Completion: October 31, 2024
• Study Completion: February 4, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-05

Locations

US (1)