Status:
NOT_YET_RECRUITING
Metabolic Health 1: Power Line Evaluation; Effect Size Determination
Lead Sponsor:
Nature's Sunshine Products, Inc.
Conditions:
Metabolic Health
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
The primary goal of this study is to demonstrate the safety and tolerability of the Power Line program, an integrated, whole-food supplement system. Secondarily, it is desired to determine the effect ...
Detailed Description
From 1960-1962, 13.4% of adults (aged 20-74) in the United States were considered obese (BMI 30.0-39.9) and less than 1% of adults were considered severely obese (BMI 40.0 and above). By 2018 the numb...
Eligibility Criteria
Inclusion
- Generally healthy Female, Male and Non-Binary adults, 18-64 years of age (Inclusive)
- Body Mass Index (BMI): 28.0-34.9 kilograms/meters2 (kg/m2) (Inclusive)
- Preference given to individuals having a minimum of two of the following markers of metabolic imbalance: fasting blood glucose ≥ 100 milligrams/deciliter (mg/dl), serum triglycerides (TG) \>100 mg/dl, serum high density lipoprotein - cholesterol (HDLc) (male sex \< 40 mg/dl, female sex \< 50 mg/dl), elevated blood pressure (systolic ≥ 120 and /or diastolic ≥ 80), elevated waist circumference (male sex ≥ 40 inches, female sex ≥ 35 inches)
- Willing to maintain a consistent diet (including medications, vitamins, and supplements) and lifestyle routine throughout the study.
- Willing to give written informed consent to participate in the Study.
Exclusion
- A serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic/rheumatological, or oncological/hematologic disease.
- Allergies related to ingredients in study products
- Known infection with HIV, TB or Hepatitis B or C.
- POCBP: Not using effective contraception.
- Blood Pressure medications or supplements
- Diabetes medications or supplements
- Cholesterol/Triglyceride lowering medications or supplements
- Currently taking nutritional supplements judged by the study coordinator to negate or camouflage the effects of the study products
- Use of Narcotics during the last 30 days
- Use of Anticoagulants during last 30 days
- Use of Corticosteroids during the last 30 days
- Use of controlled substances on a recreational basis during the last 30 days.
- Consumption of more than 3 alcoholic beverages per day. One beverage is a 5-ounce glass of wine, 12 ounces of beer, or one ounce of hard liquor.
- Inability to comply with Study and/or follow-up visits.
- Any concurrent condition (including clinically significant abnormalities in medical history, physical examination, or laboratory evaluations) which, in the opinion of the PI, would preclude safe participation in this study or interfere with compliance.
- Any sound medical, psychiatric, and/or social reason which, in the opinion of the PI, would preclude safe participation in this Study or interfere with compliance.
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Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06486077
Start Date
August 1 2024
End Date
December 1 2024
Last Update
July 3 2024
Active Locations (1)
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1
The Hughes Center for Research and Innovation
Lehi, Utah, United States, 84043