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Clinical Trials/NCT06181214
NCT06181214CompletedNot Applicable

The Effects of a Novel Nutritional Product on Nutrient Status and Digestive Health

Athletic Greens International2 sites in 1 country30 target enrollmentStarted: August 14, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
2
Primary Endpoint
Gut Microbiome

Study Overview

Brief Summary

This study is a randomized, double-blind, placebo-controlled study of N=30 apparently healthy men and women. This is an exploratory study to assess the effect of a novel dietary supplement on blood markers of nutrient status and the gut microbiome.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Provide voluntary signed and dated informed consent.
  • Be in good health as determined by medical history and routine blood chemistries.
  • Age between 18 and 50 yr (inclusive).
  • Body Mass Index of 18.5-29.9 (inclusive).
  • Body weight of at least 120 pounds.
  • Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
  • Normal seated, resting heart rate (<90 per minute).
  • Willing to duplicate their previous 24-hour diet, refrain from caffeine and exercise for 24 hours prior to each visit, and fast for 10 hours prior to each visit.
  • 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. Women who participate in this study must agree to the use of contraception for the duration of the study and any woman that is sexually active will have to take a negative pregnancy test prior to enrolling. Women of childbearing age (any woman prior to menopause) regardless of their use of contraception will be provided a urine pregnancy test kit at their screening visit and take the test in private using the female lavatory after signing an informed consent.
  • 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.

Outcomes

Primary Outcomes

Gut Microbiome

Time Frame: 28 days

Examine changes in the gut microbiome structure and function measured by shallow shotgun metagenomics. Examine enrichment of taxa and metabolic pathways in the gut microbiome as a result of dietary supplementation.

Secondary Outcomes

  • Exploratory Digestive Measures(28 days)
  • Complete Blood Count(28 Days)
  • Exploratory nutrient status markers(28 days)
  • Exploratory Stool Consistency(28 days)
  • Complete Metabolic Blood Panel(28 Days)
  • Exploratory Stool Frequency(28 days)

Investigators

Sponsor
Athletic Greens International
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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