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Dietary Supplementation on Body Fat Composition | Clinical Trials | Clareo Health

RECRUITINGNA

Dietary Supplementation on Body Fat Composition

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

NCT06296251•Brightseed

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male or female, ≥18 years of age at visit 1 (week -1).
•2. Body mass index (BMI) of ≥28.0 kg/m2 to \<35.0 kg/m2 at visit 1 (week -1).
•3. 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 visit1.
•4. 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.
+2 more criteria

Exclusion Criteria

•1. Weight loss or gain ≥4.5 kg within 90 days of visit 1.
•2. Use of weight loss medications within 90 days of visit 1
•3. History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes.
•4. 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.
•5. History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator.
•6. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
•7. Current medical diagnosis of type 1 or type 2 diabetes mellitus.
•8. HbA1c ≥48 mmol/mol (6.5%) as measured at visit 1.
•9. History of a chronic gastrointestinal disorder, such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).
•10. History of liver disease with exception of non-alcoholic fatty livery disease (NAFLD).
+11 more criteria

Locations (1)

Biofortis Research

Addison, Illinois, United States

Key Dates

Start Date

April 18, 2024

Primary Completion Date

December 27, 2024

Completion Date

February 27, 2025

Last Updated

May 16, 2024

Enrollment

150

ESTIMATED participants

Conditions

DyslipidemiasPre-diabetes

Interventions

Placebo treatment

OTHER

Plant derived phenolics

DIETARY_SUPPLEMENT

Contacts

Doug Bolster

CONTACT

(415) 965-7778 dbolster@brightseedbio.com

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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: May 16, 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 Body Fat Composition

Inclusion Criteria

Exclusion Criteria

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