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

NCT ID: NCT06521424

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Maltodextrin + Flavoring

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin placebo

AG1 - Nutritional Supplement

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

Group Type: EXPERIMENTAL

AG1 - Nutritional Supplement

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

AG1 - Nutritional Supplement

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Maltodextrin placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Athletic Greens International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hofstra University

Hempstead, New York, United States

Countries

United States

Other Identifiers

AG-01-0722

Identifier Type: -

Identifier Source: org_study_id