Dietary Supplement for Obesity

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Brightseed

Must not be taking: Weight loss medications

Disqualifiers: Diabetes, Hypertension, Cancer, others

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

History of regular menstrual cycles for at least 3 months prior to visit 1

I have been on the same non-weight loss meds for at least 90 days.

Willing to maintain habitual diet with exceptions

Exclusion Criteria

Health conditions preventing study requirements

I have not taken weight loss medications in the last 90 days.

I have been diagnosed with an eating disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily consumption of encapsulated N-trans-caffeoyl tyramine and N-trans-feruloyl tyramine at a dose of 120 mg/d for 4 weeks

4 weeks

Multiple visits on Day 1 and Day 28

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• N-trans-caffeoyl tyramine (NCT) and N-trans-feruloyl tyramine (NFT)

Trial Overview 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.

Participant Groups

Group I: Active high dose of plant derived phenolics Active Control 1 Intervention

Group II: Placebo Treatment Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Brightseed

Lead Sponsor

Trials

6

Recruited

560+