The Effects of a Novel Nutritional Product on Nutrient Gaps and Gut Health in Active Adults

NCT06521424 | Completed

• 1 other identifier: AG-01-0722
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blind, placebo-controlled study of N=20 active men and women. This study to assess the effect of a novel dietary supplement on improving nutrient gaps and the gut microbiome.

Conditions

Gastrointestinal Microbiome; Nutrition, Healthy; Exercise

Outcome Measures

Primary Outcomes (2)

• Gut Microbiome

  Examine changes in the gut microbiome via fecal polar metabolomics measured by LC/MS

  14 days

• Nutrient Gaps

  Assess nutrient gaps by dietary record assessment utilizing The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool

  14 days

Secondary Outcomes (1)

• Exploratory Digestive Measures

  14 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Maltodextrin + Flavoring

Dietary Supplement: Placebo

AG1 - Nutritional Supplement

EXPERIMENTAL

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

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

You may qualify if:

• Provide voluntary signed and dated informed consent.
• Be in good health as determined by medical history and routine blood chemistries.
• \> 1 year of resistance training experience (minimum of 2 days per week of resistance training session with free weights)
• Age between 18 and 40 yr (inclusive).
• Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
• Subject is willing and able to comply with the study protocol.

You may not qualify if:

• History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal conditions.
• History of diabetes or endocrine disorder.
• History of use of medications or dietary supplements known to confound the study or its endpoints.
• 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, Irritable bowel syndrome (IBS), diarrheal illnesses, history of colon resection, gastro paresis, 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 become pregnant, women less than 120 days postpartum or nursing women.
• Known 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.
• Any other conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.

Sponsors & Collaborators

• Athletic Greens International: lead

Study Sites (1)

Hofstra University

Hempstead, New York, 11549, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

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

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

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: August 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 31, 2024
• Last Updated: May 4, 2025

Record last verified: 2025-05

Locations

US (1)