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Dietary Supplementation on Fat Oxidation | Clinical Trials | Clareo Health

RECRUITINGNA

Dietary Supplementation on Fat Oxidation

A Randomized, Double-blind, Parallel Study to Examine the Effects of N-trans-caffeoyl Tyramine and N-trans-feruloyl Tyramine Bioactives on Fat Oxidation in Adult Women With Overweight and Obesity

NCT06548048•Brightseed

View on ClinicalTrials.gov

Summary

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

Age

18 - 50 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Female, ≥18 and \<50 years of age at visit 1 (day -28).
•2. Body mass index (BMI) of ≥29.0 kg/m2 to \<40.0 kg/m2 at visit 1 (day -28).
•3. No health conditions that would prevent fulfilling the study requirements as judged by the Investigator on the basis of medical history.
•4. History of regular menstrual cycles with menses (21-35 d per cycle) for at least 3 months prior to visit 1 (day -28).
•5. Stable use of non-weight loss (e.g., semaglutide) prescription medications allowed, where stable use is defined as the same class of medication and dose for at least 90 d prior to visit 1 (day -28).
•6. Willing to discontinue any dietary supplement use (except for conventional once daily vitamin/mineral supplement\[s\]), for one week prior to visit 2 and throughout the study.
•7. Non-user or former user (cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) with no plans to begin use during the study period.
•8. Willing to maintain habitual diet (with the exception of restricted foods/beverages) throughout the study period.
•9. Willing to use personal web-based device (e.g., smart phone, tablet, or laptop) with operating system (Android version 12.0 or newer; iOS version 16 or newer) capable of downloading the Cronometer app for diet records.
•10. Willing to adhere to all study procedures and signs forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.

Exclusion Criteria

•1. Unwilling to wear a tampon during the collection of the 24-h urine samples when these collections occur during the time of menstruation
•2. Weight loss or gain ≥4.5 kg within 90 days of visit 1 (day -28).
•3. Use of weight loss medications within 90 days of visit 1 (day -28).
•4. Any health condition that would prevent the participant from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history. Health conditions may include history or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator.
•5. History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes.
•6. Use of dietary supplements or related products that, in the judgment of the Investigator, are likely to markedly affect weight loss or appetite within 30 days of visit 1.
•7. History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator.
•8. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
•9. Current medical diagnosis of type 1 or type 2 diabetes mellitus.
•10. History of a chronic gastrointestinal disorder, such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).
+11 more criteria

Locations (1)

Biofortis

Addison, Illinois, United States

Key Dates

Start Date

July 31, 2024

Primary Completion Date

November 5, 2024

Completion Date

December 31, 2024

Last Updated

August 12, 2024

Enrollment

ESTIMATED participants

Conditions

OverweightObesity

Interventions

Dietary supplement containing plant derived phenolics

DIETARY_SUPPLEMENT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dietary Supplementation on Fat Oxidation

Inclusion Criteria

Exclusion Criteria

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