A Randomized, Double-Blind, Placebo-Controlled, Three-Arm Parallel Study to Investigate the Effects of a Dietary Supplement Containing N-trans-Caffeoyltyramine (NCT) and N-trans-Feruloyltyramine (NFT) on Body Fat Composition

Brightseed1 site in 1 country150 target enrollmentApril 18, 2024

ConditionsDyslipidemias Pre-diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dyslipidemias
Sponsor: Brightseed
Enrollment: 150
Locations: 1
Primary Endpoint: Body fat mass
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels in otherwise generally healthy adults with risk factors (high BMI at dyslipidemia and/or pre-diabetes) for body fat composition. The primary hypothesis is that supplementation with plant derived phenolics will decrease body fat composition compared to placebo.

Registry

clinicaltrials.gov

Start Date

April 18, 2024

End Date

February 27, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Brightseed

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female, ≥18 years of age at visit 1 (week -1).
•Body mass index (BMI) of ≥28.0 kg/m2 to \<35.0 kg/m2 at visit 1 (week -1).
•At least one of the following comorbidities based on blood draws at visit 1:
•Dyslipidemia (any of the following)
•Total-C ≥200 mg/dL
•LDL-C ≥130 mg/dL
•HDL-C ≤40 mg/dL
•Triglycerides ≥150 mg/dL
•Pre-diabetes o HbA1c ≥5.7 to ≤6.4% Stable use of medications allowed, where stable use is defined as the same dose for at least 90 d prior to visit
•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.

Exclusion Criteria

•Weight loss or gain ≥4.5 kg within 90 days of visit
•Use of weight loss medications within 90 days of visit 1
•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
•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.
•HbA1c ≥48 mmol/mol (6.5%) as measured at visit
•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).