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

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.

Study Overview

• Status: Recruiting
• Conditions: Dyslipidemias; Pre-diabetes
• Intervention / Treatment: Other: Placebo treatment; Dietary supplement: Plant derived phenolics

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Doug Bolster; Phone Number: (415) 965-7778; Email: dbolster@brightseedbio.com

Study Locations

• United States
  • Illinois
    • Addison, Illinois, United States, 60101
      • Recruiting
      • Biofortis Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.
5. Willing to maintain a stable intake of current dietary supplements and medications not specifically listed as exclusionary or deemed to interfere with study outcomes throughout study duration.
6. 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. 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. Unstable use of medications for mental or emotional disorders, where stable use is defined as the same dose for ≥90 days prior to visit 1.
12. Uncontrolled stage 2 hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at visit 1. Participants with hypertension on a stable dose of medication may be allowed in the study per Investigator's discretion. Stable dose is defined as same dose for >90 days.
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. Unstable use of thyroid hormone replacement medication, where stable use is defined as the same dose for ≥90 days prior to visit 1.
16. Known intolerance or sensitivity to any ingredients in the study products.
17. Exposure to any non-registered drug product within 4 weeks prior to visit 1.
18. 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.
19. 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.
20. 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).
21. Any condition the Investigator believes would interfere with his or 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo treatment; Placebo treatment (Microcrystaline cellulose): 1 capsule/day	Other: Placebo treatment; Microcrystaline cellulose (MCC)
Active Comparator: Active low dose of plant derived phenolics; Active low dose of plant derived phenolics via 1 capsule/day	Dietary supplement: Plant derived phenolics; Dietary supplement containing plant derived phenolics
Active Comparator: Active high dose of plant derived phenolics; Active high dose of plant derived phenolics via 1 capsule/day	Dietary supplement: Plant derived phenolics; Dietary supplement containing plant derived phenolics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body fat mass	Body fat mass (kg) change by the DEXA scan.	0, 12, 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Measured by the DEXA scan: o Percent fat mass (%), expressed as a percentage of the total body mass	0, 12, 24 weeks
Android fat mass	Measured by the DEXA scan: o Android fat mass (kg)	0, 12, 24 weeks
Gynoid fat mass	Measured by the DEXA scan: o Gynoid fat mass (kg)	0, 12, 24 weeks
Abdominal visceral fat mass	Measured by the DEXA scan: o Abdominal visceral fat mass (g)	0, 12, 24 weeks
Abdominal circumference	measured by the 3D body scan: o Waist (abdominal) circumference (cm)	0, 12, 24 weeks
Hip circumference	measured by the 3D body scan: o Hip circumference (cm)	0, 12, 24 weeks
Chest circumference	measured by the 3D body scan: o Chest circumference (cm)	0, 12, 24 weeks
Upper thigh circumference	measured by the 3D body scan: o Upper thigh (average of left and right thighs) circumference (cm)	0, 12, 24 weeks
Upper arm circumference	measured by the 3D body scan: o Upper arm bicep (average of left and right arms) circumference (cm)	0, 12, 24 weeks
Waist to hip ratio	measured by the 3D body scan: o Waist (abdominal) to hip ratio	0, 12, 24 weeks
Fasting glucose	Fasting glucose through blood	0, 12, 24 weeks
Fasting insulin	Fasting insulin through blood	0, 12, 24 weeks
HbA1c	HbA1c through blood	0, 12, 24 weeks
FGF21	FGF21 through blood	0, 24 weeks
Systolic blood pressure	Systolic blood pressure (mmHg)	0, 4, 8,12, 24 weeks
Diastolic blood pressure	Diastolic blood pressure (mmHg)	0, 4, 8,12, 24 weeks
Total-Cholesterol	Total-C through blood	0, 12, 24 weeks
HDL-C	HDL-C through blood	0, 12, 24 weeks
LDL-C	LDL-C through blood	0, 12, 24 weeks
VLDL-C	VLDL-C through blood	0, 12, 24 weeks
non-HDL-C	non-HDL-C through blood	0, 12, 24 weeks
Triglycerides	Triglycerides through blood	0, 12, 24 weeks
Body Weight	Change in body weight from week 0 to each measured follow-up visit	0, 4, 8, 12, 16, 20, and 24 weeks
Total kcals	Total kcals via FFQ dietary intake parameters	0, 12, 24 weeks
Total fat	Total fat via FFQ dietary intake parameters	0, 12, 24 weeks
Total protein	Total protein via FFQ dietary intake parameters	0, 12, 24 weeks
Total carbohydrates	Total carbohydrates via FFQ dietary intake parameters	0, 12, 24 weeks
Fiber	Fiber via FFQ dietary intake parameters	0, 12, 24 weeks
ALT	Changes in the chemistry profile for safety parameters	0, 12, 24 weeks
AST	Changes in the chemistry profile for safety parameters	0, 12, 24 weeks
Physical functioning	Physical functioning via 36-Item Short Form Health Survey (SF-36) questionnaire. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	0, 12, 24 weeks
Bodily pain	Bodily pain via 36-Item Short Form Health Survey (SF-36) questionnaire. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	0, 12, 24 weeks
Role limitations due to physical health	Role limitations due to physical health via 36-Item Short Form Health Survey (SF-36) questionnaire. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	0, 12, 24 weeks
Role limitation due to personal or emotional problems	Role limitation due to personal or emotional problems via 36-Item Short Form Health Survey (SF-36) questionnaire. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	0, 12, 24 weeks
Emotional well-being	Emotional well-being via 36-Item Short Form Health Survey (SF-36) questionnaire. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	0, 12, 24 weeks
Social functioning	Social functioning via 36-Item Short Form Health Survey (SF-36) questionnaire. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	0, 12, 24 weeks
Energy/Fatigue	Energy/Fatigue via 36-Item Short Form Health Survey (SF-36) questionnaire. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	0, 12, 24 weeks
General health perceptions	General health perceptions via 36-Item Short Form Health Survey (SF-36) questionnaire. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	0, 12, 24 weeks
Healthy Eating Index (HEI) score	Healthy Eating Index (HEI) score via Food Frequency Questionnaire (FFQ) dietary intake parameters. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations and dietary patterns published in the Dietary Guidelines.	0, 12, 24 weeks

Collaborators and Investigators

• Sponsor: Brightseed

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2024
• Primary Completion (Estimated): December 27, 2024
• Study Completion (Estimated): February 27, 2025

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Lipid Metabolism Disorders; Prediabetic State; Dyslipidemias
• Other Study ID Numbers: BIO-2313

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No