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

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.

Study Overview

• Status: Completed
• Conditions: Exercise; Nutrition, Healthy; Gastrointestinal Microbiome
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: AG1 - Nutritional Supplement

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Hempstead, New York, United States, 11549
      • Hofstra University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Maltodextrin + Flavoring	Dietary supplement: Placebo; Maltodextrin placebo
Experimental: AG1 - Nutritional Supplement; A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients	Dietary supplement: AG1 - Nutritional Supplement; A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Digestive Measures	A Digestive Quality of Life Questionnaire (DQLQ) will be utilized to assess the effect of the interventions on participant's digestive health. Scores range from 0 to 9 with a higher score indicating worse digestion associated with quality of life	14 days

Collaborators and Investigators

• Sponsor: Athletic Greens International

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: AG-01-0722

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No