Actively Recruiting
Dietary Supplementation on Fat Oxidation
Led by Brightseed · Updated on 2024-08-12
16
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this pilot study is to evaluate the effects of 4 weeks of daily consumption of encapsulated N-trans-caffeoyl tyramine (NCT) and N-trans-feruloyl tyramine (NFT) at a dose of 120 mg/d on measures of fat oxidation in women with overweight or obesity. The hypothesis is that fat oxidation at rest (measured via indirect calorimetry) and over a 24 h period (measured via d31-palmitic acid stable isotope tracer) will be higher in the group receiving the active study product compared to the control product at the end of the 4-week consumption period.
CONDITIONS
Official Title
Dietary Supplementation on Fat Oxidation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, aged 18 to less than 50 years at first visit
- Body mass index (BMI) between 29.0 and less than 40.0 kg/m2 at first visit
- No health conditions preventing study participation as judged by the Investigator
- Regular menstrual cycles with periods every 21 to 35 days for at least 3 months before the first visit
- Stable use of non-weight loss prescription medications for at least 90 days before the first visit
- Willingness to stop dietary supplements except daily vitamins/minerals one week before second visit and during the study
- Non-user or former user of tobacco or nicotine products for at least 12 months with no plans to start during the study
- Willing to maintain usual diet with some restricted foods and drinks during the study
- Willing to use a personal device capable of downloading the Cronometer app for diet recording
- Willing to follow all study procedures and give informed consent
You will not qualify if you...
- Unwilling to wear a tampon during 24-hour urine sample collection if it occurs during menstruation
- Weight change of 4.5 kg or more within 90 days before the first visit
- Use of weight loss medications within 90 days before the first visit
- Health conditions preventing participation as judged by the Investigator, including serious heart, kidney, liver, endocrine, lung, bile, pancreas, or nervous system disorders
- History of gastrointestinal or cosmetic surgery for weight or fat reduction
- Use of supplements likely to affect weight or appetite within 30 days before the first visit
- History of extreme diets like Atkins
- Diagnosed eating disorders
- Current diagnosis of type 1 or type 2 diabetes
- Chronic gastrointestinal disorders except mild lactose intolerance or acid reflux
- History of liver disease except non-alcoholic fatty liver disease
- Uncontrolled high blood pressure (systolic ≥160 mm Hg or diastolic ≥100 mm Hg)
- Daily use of marijuana, hemp, or CBD products within 30 days before the first visit
- History or presence of cancer within 2 years except non-melanoma skin cancer
- Known intolerance or sensitivity to study product ingredients
- Use of non-registered drug products within 30 days before the first visit
- Signs or symptoms of active infection within 5 days before the first visit
- Pregnant, planning pregnancy, lactating, or unwilling to use approved contraception during the study
- Alcohol or substance abuse within 12 months before the first visit
- Any condition interfering with consent, compliance, or safety as judged by the Investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Biofortis
Addison, Illinois, United States, 60101
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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