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OpenTrials
Completed

NCT Number: NCT06521424

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hofstra University

Hempstead, New York, 11549, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AG1 - Nutritional Supplement

Dietary Supplement

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

Placebo

Dietary Supplement

Maltodextrin placebo

Primary outcomes

  1. Gut Microbiome

    Time frame: 14 days

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

  2. Nutrient Gaps

    Time frame: 14 days

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

Secondary outcomes

  1. Exploratory Digestive Measures

    Time frame: 14 days

    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

Sponsors and collaborators

Lead sponsor

Athletic Greens International

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 26, 2024
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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