Dietary Supplementation on Fat Oxidation

NCT06548048 | Recruiting

• 1 other identifier: BIO-2406
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• % deuterium (2H) label from oxidation of d31-palmitic acid

  Percentage recovery of the deuterium (2H) label from oxidation of d31-palmitic acid to water in urine samples collected

  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)

Secondary Outcomes (7)

• Change in indirect calorimetry measures

  day 1 and day 28

• Change in indirect calorimetry measures

  day 1 and day 28

• Change in cardiometabolic parameters

  day 1 and day 28

• Change in cardiometabolic parameters

  day 1 and day 28

• Change in cardiometabolic parameters

  day 1 and day 28

Study Arms (2)

Placebo Treatment

PLACEBO COMPARATOR

Dietary Supplement: Microcrystaline cellulose

Active high dose of plant derived phenolics

ACTIVE COMPARATOR

Dietary Supplement: Dietary supplement containing plant derived phenolics

Interventions

Dietary supplement containing plant derived phenolics DIETARY_SUPPLEMENT

Dietary supplement containing plant derived phenolics

Active high dose of plant derived phenolics

Microcrystaline cellulose DIETARY_SUPPLEMENT

Microcrystaline cellulose (MCC)

Placebo Treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female, ≥18 and \<50 years of age at visit 1 (day -28).
• Body mass index (BMI) of ≥29.0 kg/m2 to \<40.0 kg/m2 at visit 1 (day -28).
• No health conditions that would prevent fulfilling the study requirements as judged by the Investigator on the basis of medical history.
• History of regular menstrual cycles with menses (21-35 d per cycle) for at least 3 months prior to visit 1 (day -28).
• 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).
• 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.
• 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.
• Willing to maintain habitual diet (with the exception of restricted foods/beverages) throughout the study period.
• 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.
• 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.

You may not qualify if:

• Unwilling to wear a tampon during the collection of the 24-h urine samples when these collections occur during the time of menstruation
• Weight loss or gain ≥4.5 kg within 90 days of visit 1 (day -28).
• Use of weight loss medications within 90 days of visit 1 (day -28).
• 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.
• History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes.
• 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.
• History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator.
• History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
• Current medical diagnosis of type 1 or type 2 diabetes mellitus.
• History of a chronic gastrointestinal disorder, such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).
• History of liver disease with exception of non-alcoholic fatty livery disease (NAFLD).
• 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.
• Habitual use (i.e., daily) of marijuana and hemp products including CBD products within 30 days of visit 1.
• History or presence of cancer (including any malignant GI polyps) within 2 years of visit 1, except for non-melanoma skin cancer.
• Known intolerance or sensitivity to any ingredients in the study products.

Sponsors & Collaborators

• Brightseed: lead

Study Sites (1)

Biofortis

Addison, Illinois, 60101, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

microcrystalline cellulose

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 12, 2024
• Study Start: July 31, 2024
• Primary Completion: November 5, 2024
• Study Completion: December 31, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)