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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a natural supplement, specifically N-trans-caffeoyl tyramine (NCT) and N-trans-feruloyl tyramine (NFT), might help women with overweight or obesity burn more fat. Participants will take a daily dose of these plant-derived compounds for four weeks to determine if they boost fat burning at rest and throughout the day compared to a placebo. Women with a BMI between 29 and 40 and regular menstrual cycles might be suitable candidates. Participants should maintain their usual diet and refrain from using weight loss supplements during the trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding the potential benefits of natural supplements for weight management.

Will I have to stop taking my current medications?

You can continue taking your current prescription medications as long as they are not for weight loss and have been stable for at least 90 days before the study starts. However, you will need to stop using any dietary supplements, except for regular daily vitamins, one week before the study and throughout its duration.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that N-trans-caffeoyl tyramine (NCT) and N-trans-feruloyl tyramine (NFT) have been studied for their effects on digestive health. In earlier studies, participants took these compounds for three weeks, and the results showed improvements in some digestive symptoms without major safety issues. These studies suggest that NCT and NFT are generally safe to use.

However, clear information about their long-term safety or effects at different doses is still lacking. This current study is in the early stages and primarily aims to assess whether these compounds can aid in fat burning, rather than focusing on detailed safety information. Treatments in early research often have limited safety data, and participants should consider this when deciding whether to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about N-trans-caffeoyl tyramine (NCT) and N-trans-feruloyl tyramine (NFT) for obesity because they offer a fresh approach to weight management. Unlike existing options like diet, exercise, and medications that primarily alter appetite or fat absorption, these compounds are plant-derived phenolics. This means they could potentially offer a natural alternative with a novel mechanism of action, possibly affecting metabolism directly. Such a distinctive method could lead to new insights and breakthroughs in obesity treatment, making these treatments a promising area of study.

What evidence suggests that this treatment might be an effective treatment for obesity?

This trial will evaluate the effects of N-trans-caffeoyl tyramine (NCT) and N-trans-feruloyl tyramine (NFT) on obesity. Studies have shown that these compounds may positively impact metabolism and liver health in animals. In mice with diet-induced obesity, NCT improved liver function by restoring a key protein for metabolism and reducing fatty liver. Although these results come from animal studies, they suggest that NCT and NFT might help the body burn fat more effectively. However, limited information exists on their effects in humans, particularly concerning obesity, so this remains theoretical. Overall, early research supports the idea that these compounds could aid in fat burning, but more studies are needed to confirm this in people. Participants in this trial will receive either an active high dose of plant-derived phenolics or a placebo to assess these effects. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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

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

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

Willing to maintain habitual diet with exceptions

Exclusion Criteria

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

Health conditions preventing study requirements

Recent history of alcohol or substance abuse

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. jscimedcentral.com jscimedcentral.com/jounal-article-info/Journal-of-Preventive-Medicine-and-Health-Care/Effects-of-N-Trans-Caffeoyltyramine-NCT-and-N-Trans-Feruloyltyramine-NFT-Supplementation-in-Individuals-with-Diarrhea-PredominantIrritable-Bowel-Syndrome-12318

Effects of N-Trans Caffeoyltyramine (NCT) and ... Conclusions: NCT/NFT intake for 3 weeks led to a significant improvement in L/M ratio, LBP and IBS-SSS abdominal distention scores, and a trend ...

2. ffhdj.com ffhdj.com/index.php/BioactiveCompounds/article/download/1655/4509

Effects of N-Trans Caffeoyltyramine and N-Trans ... Conclusions: NCT/NFT intake for 3 weeks led to a significant improvement in L/M ratio, LBP, and IBS-SSS abdominal distention scores, and a trend ...

3. sciety.org sciety.org/articles/activity/10.20944/preprints202504.2435.v1

Effects of N-Trans Caffeoyltyramine (NCT) and N ... - Sciety Conclusions: NCT/NFT intake for 3 weeks led to a significant improvement in L/M ratio, LBP and IBS-SSS abdominal distention scores, and a trend ...

4. preprints.org preprints.org/manuscript/202504.2435/v1

Effects of N-Trans Caffeoyltyramine (NCT) and ... Conclusions: NCT/NFT intake for 3 weeks led to a significant improvement in L/M ratio, LBP and IBS-SSS abdominal distention scores, and a trend ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2001037024004367

Structure-based identification of HNF4α agonists ... Furthermore, in diet-induced obesity (DIO) mouse models, NCT was found to restore hepatic HNF4α expression and alleviate fatty liver [12]. These findings ...

6. withpower.com withpower.com/trial/phase-overweight-6-2024-d91b7

Dietary Supplement for Obesity 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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06262880?term=The%20Functional%20Gut%20Clinic%C2%A0N-trans-caffeoyltyramine%20(NCT)%20and%20N-trans-feruloyltyramine%20(NFT)%20&rank=2

Dietary Supplementation on Gastrointestinal Barrier Function The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels on ...