Actively Recruiting
Dietary Supplementation on Body Fat Composition
Led by Brightseed · Updated on 2024-05-16
150
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels in otherwise generally healthy adults with risk factors (high BMI at dyslipidemia and/or pre-diabetes) for body fat composition. The primary hypothesis is that supplementation with plant derived phenolics will decrease body fat composition compared to placebo.
CONDITIONS
Official Title
Dietary Supplementation on Body Fat Composition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18 years of age or older at visit 1 (week -1)
- Body mass index (BMI) of 28.0 kg/m2 to less than 35.0 kg/m2 at visit 1 (week -1)
- At least one of the following comorbidities based on blood draws at visit 1:
- Dyslipidemia with any of: Total cholesterol ≥200 mg/dL, LDL cholesterol ≥130 mg/dL, HDL cholesterol ≤40 mg/dL, or triglycerides ≥150 mg/dL
- Pre-diabetes with HbA1c 5.7 to 6.4%, with stable medication use for at least 90 days prior to visit 1
- Non-user or former user (stopped ≥12 months ago) of tobacco or nicotine products with no plans to start during the study
- Willing to maintain a stable intake of current dietary supplements and medications not excluded or interfering with study outcomes throughout the study
- Willing to follow all study procedures and sign informed consent and authorization to release protected health information to the Clinical Investigator
You will not qualify if you...
- Weight loss or gain of 4.5 kg or more within 90 days before visit 1
- Use of weight loss medications within 90 days before visit 1
- History of gastrointestinal surgery or cosmetic procedures for weight/fat reduction
- Use of dietary supplements likely to affect weight loss or appetite within 30 days before visit 1
- History of extreme dietary habits as judged by the Investigator
- History of an eating disorder diagnosed by a health professional
- Current diagnosis of type 1 or type 2 diabetes mellitus
- HbA1c 6.5% or higher at visit 1
- History of chronic gastrointestinal disorders like peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or reflux disease allowed)
- History of liver disease except non-alcoholic fatty liver disease
- Unstable use of medications for mental or emotional disorders (stable use defined as same dose for at least 90 days prior to visit 1)
- Uncontrolled stage 2 hypertension (blood pressure ≥140/90 mm Hg) at visit 1 unless on a stable medication dose
- Daily use of marijuana or hemp products including CBD within 30 days before visit 1
- History or presence of cancer within 2 years before visit 1, except non-melanoma skin cancer
- Unstable use of thyroid hormone replacement medication (stable use defined as same dose for at least 90 days prior to visit 1)
- Known intolerance or sensitivity to any study product ingredients
- Exposure to any non-registered drug product within 4 weeks before visit 1
- Signs or symptoms of an active infection within 5 days before visit 1
- Female who is pregnant, planning pregnancy, lactating, or of childbearing potential unwilling to use approved contraception during the study
- History of alcohol or substance abuse within 12 months before visit 1
- Any condition that would interfere with consent, study compliance, or interpretation of results as judged by the Investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Biofortis Research
Addison, Illinois, United States, 60101
Actively Recruiting
Research Team
D
Doug Bolster
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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