Dietary Supplementation on Fat Oxidation

Launched by BRIGHTSEED · Aug 8, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a dietary supplement made from specific compounds (N-trans-caffeoyl tyramine and N-trans-feruloyl tyramine) can help women who are overweight or obese burn fat more effectively. The study will last 4 weeks, and during this time, participants will take a daily dose of 120 mg of the supplement. Researchers will measure how well the body burns fat at rest and throughout the day to see if the supplement has a positive effect compared to a control product.

To participate, women must be between the ages of 18 and 50, have a body mass index (BMI) of 29 to 40, and be generally healthy without certain medical conditions. They should also have regular menstrual cycles and be willing to track their diet using a smartphone app. Participants will need to avoid certain dietary supplements and maintain their usual eating habits during the study. This trial is currently recruiting, so if you meet the criteria and are interested, it could be a great opportunity to contribute to important research while potentially benefiting your health.

Gender

FEMALE

Eligibility criteria

• • 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. History of liver disease with exception of non-alcoholic fatty livery disease (NAFLD).
• • 12. Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the blood pressure measured at visit 1.
• • 13. Habitual use (i.e., daily) of marijuana and hemp products including CBD products within 30 days of visit 1.
• • 14. History or presence of cancer (including any malignant GI polyps) within 2 years of visit 1, except for non-melanoma skin cancer.
• • 15. Known intolerance or sensitivity to any ingredients in the study products.
• • 16. Exposure to any non-registered drug product within 30 days prior to visit 1.
• • 17. Signs or symptoms of an active infection of clinical relevance\* within 5 days of visit 1. The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to visit 1.
• • 18. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document.
• • 19. Recent history (within 12 months of visit 1) of alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks per week (1 drink = 12 oz. beer, 5 oz. wine, or 1½ oz. distilled spirits).
• • 20. Any condition the Investigator believes would interfere with her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
• • If an infection occurs during the study period, test visits will be rescheduled until signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to the scheduled study visits.