Dietary Supplementation on Body Fat Composition

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06296251
• Other study ID #: BIO-2313
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2024
• Est. completion date: February 27, 2025

Study information

• Verified date: May 2024
• Source: Brightseed
• Contact: Doug Bolster
• Phone: (415) 965-7778
• Email: dbolster[@]brightseedbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 27, 2025
• Est. primary completion date: December 27, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias
• Pre-diabetes
• Prediabetic State

Intervention

Other:
• Placebo treatment
Microcrystaline cellulose (MCC)

Dietary Supplement:
• Plant derived phenolics
Dietary supplement containing plant derived phenolics

Locations

Country	Name	City	State
United States	Biofortis Research	Addison	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Brightseed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body fat mass	Body fat mass (kg) change by the DEXA scan.	0, 12, 24 weeks
Secondary	Body composition	Measured by the DEXA scan: o Percent fat mass (%), expressed as a percentage of the total body mass	0, 12, 24 weeks
Secondary	Android fat mass	Measured by the DEXA scan: o Android fat mass (kg)	0, 12, 24 weeks
Secondary	Gynoid fat mass	Measured by the DEXA scan: o Gynoid fat mass (kg)	0, 12, 24 weeks
Secondary	Abdominal visceral fat mass	Measured by the DEXA scan: o Abdominal visceral fat mass (g)	0, 12, 24 weeks
Secondary	Abdominal circumference	measured by the 3D body scan: o Waist (abdominal) circumference (cm)	0, 12, 24 weeks
Secondary	Hip circumference	measured by the 3D body scan: o Hip circumference (cm)	0, 12, 24 weeks
Secondary	Chest circumference	measured by the 3D body scan: o Chest circumference (cm)	0, 12, 24 weeks
Secondary	Upper thigh circumference	measured by the 3D body scan: o Upper thigh (average of left and right thighs) circumference (cm)	0, 12, 24 weeks
Secondary	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
Secondary	Waist to hip ratio	measured by the 3D body scan: o Waist (abdominal) to hip ratio	0, 12, 24 weeks
Secondary	Fasting glucose	Fasting glucose through blood	0, 12, 24 weeks
Secondary	Fasting insulin	Fasting insulin through blood	0, 12, 24 weeks
Secondary	HbA1c	HbA1c through blood	0, 12, 24 weeks
Secondary	FGF21	FGF21 through blood	0, 24 weeks
Secondary	Systolic blood pressure	Systolic blood pressure (mmHg)	0, 4, 8,12, 24 weeks
Secondary	Diastolic blood pressure	Diastolic blood pressure (mmHg)	0, 4, 8,12, 24 weeks
Secondary	Total-Cholesterol	Total-C through blood	0, 12, 24 weeks
Secondary	HDL-C	HDL-C through blood	0, 12, 24 weeks
Secondary	LDL-C	LDL-C through blood	0, 12, 24 weeks
Secondary	VLDL-C	VLDL-C through blood	0, 12, 24 weeks
Secondary	non-HDL-C	non-HDL-C through blood	0, 12, 24 weeks
Secondary	Triglycerides	Triglycerides through blood	0, 12, 24 weeks
Secondary	Body Weight	Change in body weight from week 0 to each measured follow-up visit	0, 4, 8, 12, 16, 20, and 24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Total kcals	Total kcals via FFQ dietary intake parameters	0, 12, 24 weeks
Secondary	Total fat	Total fat via FFQ dietary intake parameters	0, 12, 24 weeks
Secondary	Total protein	Total protein via FFQ dietary intake parameters	0, 12, 24 weeks
Secondary	Total carbohydrates	Total carbohydrates via FFQ dietary intake parameters	0, 12, 24 weeks
Secondary	Fiber	Fiber via FFQ dietary intake parameters	0, 12, 24 weeks
Secondary	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
Secondary	ALT	Changes in the chemistry profile for safety parameters	0, 12, 24 weeks
Secondary	AST	Changes in the chemistry profile for safety parameters	0, 12, 24 weeks