Clinical trial NCT06521424: The Effects of a Novel Nutritional Product on Nutrient Gaps and Gut Health in Active Adults
Official title: The Effects of a Novel Nutritional Product on Nutrient Gaps and Gut Health in Active Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Microbiome
Nutrition, Healthy
Exercise
Lead sponsor: Athletic Greens International
Sponsor class: INDUSTRY
First posted: 2024-07-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, Double-Blind, Placebo Controlled Design
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Gut Microbiome
timeFrame: 14 days
measure: Nutrient Gaps
timeFrame: 14 days
Secondary outcomes:
measure: Exploratory Digestive Measures
timeFrame: 14 days
Other outcomes:
Locations:
city: Hempstead
country: United States
facility: Hofstra University
state: New York
Study officials:
References: