Status:
COMPLETED
The Effects of a Novel Nutritional Product on Nutrient Status and Digestive Health
Lead Sponsor:
Athletic Greens International
Conditions:
Gastrointestinal Microbiome
Nutrition, Healthy
Eligibility:
All Genders
18-50 years
Phase:
NA
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 ma...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06181214
Start Date
August 14 2023
End Date
October 4 2023
Last Update
March 22 2024
Active Locations (1)
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1
Center for Applied Health Sciences
Canfield, Ohio, United States, 44046