Status:
COMPLETED
The Effects of a Novel Nutritional Product on Nutrient Gaps and Gut Health in Active Adults
Lead Sponsor:
Athletic Greens International
Conditions:
Gastrointestinal Microbiome
Nutrition, Healthy
Eligibility:
All Genders
18-40 years
Phase:
NA
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 mi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06521424
Start Date
August 1 2024
End Date
December 31 2024
Last Update
May 4 2025
Active Locations (1)
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1
Hofstra University
Hempstead, New York, United States, 11549