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

Last updated: May 1, 2025
Sponsor: Athletic Greens International
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Placebo

AG1 - Nutritional Supplement

Clinical Study ID

NCT06521424
AG-01-0722
  • Ages 18-40
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 resistancetraining session with free weights)

  • Age between 18 and 40 yr (inclusive).

  • Subject agrees to maintain existing dietary and physical activity patternsthroughout the study period.

  • Subject is willing and able to comply with the study protocol.

Exclusion

Exclusion Criteria:

  • History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renalconditions.

  • History of diabetes or endocrine disorder.

  • History of use of medications or dietary supplements known to confound the study orits endpoints.

  • Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10drinks 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 nutrientabsorption 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, ulcerativecolitis, Lupus, HIV/AIDS, etc.).

  • Previous medical diagnosis of asthma, gout, or fibromyalgia.

  • Pregnant women, women trying to become pregnant, women less than 120 days postpartumor nursing women.

  • Known sensitivity to any ingredient in the test formulations as listed in theproduct label.

  • Currently participating in another research study with an investigational product orhave been in another research study in the past 30 days.

  • Any other conditions that, in the opinion of the medical staff, could confound theprimary endpoints or place the subject at increased risk of harm if they were toparticipate.

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
August 01, 2024
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Hofstra University

    Hempstead, New York 11549
    United States

    Site Not Available

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