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Dietary Supplement for Obesity

N/A
Recruiting
Research Sponsored by Brightseed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female, aged 18 to 49 at visit 1
Stable use of non-weight loss prescription medications for at least 90 days prior to visit 1
Must not have
History of diagnosed eating disorders
Uncontrolled hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 28 (each day measurements are done in multiple timepoints of hour 0, hour 3, hour 4, hour 8, and hour 24)
Awards & highlights

Summary

This trial aims to study the effects of taking capsules containing N-trans-caffeoyl tyramine (NCT) and N-trans-feruloyl tyramine (NFT) daily

Who is the study for?
This trial is for women with overweight or obesity issues. Participants will be taking a daily dose of a dietary supplement or a control product for 4 weeks. The study aims to see if the supplement helps increase fat burning both at rest and over a full day.
What is being tested?
The trial is testing the effects of two compounds, N-trans-caffeoyl tyramine (NCT) and N-trans-feruloyl tyramine (NFT), on fat oxidation in women with obesity. It compares these compounds against an inactive substance over four weeks.
What are the potential side effects?
Potential side effects are not specified, but as with any dietary supplement, there could be risks of digestive discomfort, allergic reactions, or other unforeseen responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged between 18 and 49.
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I have been on the same non-weight loss meds for at least 90 days.
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I do not use tobacco or nicotine products, or I used to but have quit.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with an eating disorder.
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My blood pressure is not well-controlled.
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I have not had signs of an infection in the last 5 days.
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I have gained or lost about 10 pounds in the last 3 months.
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I have been diagnosed with type 1 or type 2 diabetes.
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I have had surgery to lose weight or reduce fat.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day 28 (each day measurements are done in multiple timepoints of hour 0, hour 3, hour 4, hour 8, and hour 24)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 28 (each day measurements are done in multiple timepoints of hour 0, hour 3, hour 4, hour 8, and hour 24) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
% deuterium (2H) label from oxidation of d31-palmitic acid
Secondary study objectives
Change in body weight
Change in cardiometabolic parameters
Change in indirect calorimetry measures

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active high dose of plant derived phenolicsActive Control1 Intervention
Group II: Placebo TreatmentPlacebo Group1 Intervention

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Who is running the clinical trial?

BrightseedLead Sponsor
5 Previous Clinical Trials
546 Total Patients Enrolled
~5 spots leftby Nov 2024
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