Dietary Supplementation on Body Fat Composition

Not Applicable

Recruiting

• Conditions: Pre-diabetes; Dyslipidemias
• Interventions: Dietary Supplement: Plant derived phenolics; Other: Placebo treatment

• Registration Number: NCT06296251
• Lead Sponsor: Brightseed

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-29
• Study First Submitted QC: 2024-02-29
• Study First Posted: 2024-03-06
• Study Start: 2024-04-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16
• Primary Completion: 2024-12-27
• Study Completion: 2025-02-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active high dose of plant derived phenolics	Plant derived phenolics	Active high dose of plant derived phenolics via 1 capsule/day
Active low dose of plant derived phenolics	Plant derived phenolics	Active low dose of plant derived phenolics via 1 capsule/day
Placebo treatment	Placebo treatment	Placebo treatment (Microcrystaline cellulose): 1 capsule/day

Primary Outcome Measures

Name	Time	Method
Body fat mass	0, 12, 24 weeks	Body fat mass (kg) change by the DEXA scan.

Secondary Outcome Measures

Name	Time	Method
Fasting glucose	0, 12, 24 weeks	Fasting glucose through blood
ALT	0, 12, 24 weeks	Changes in the chemistry profile for safety parameters
Android fat mass	0, 12, 24 weeks	Measured by the DEXA scan: o Android fat mass (kg)
Upper thigh circumference	0, 12, 24 weeks	measured by the 3D body scan: o Upper thigh (average of left and right thighs) circumference (cm)
Upper arm circumference	0, 12, 24 weeks	measured by the 3D body scan: o Upper arm bicep (average of left and right arms) circumference (cm)
Body composition	0, 12, 24 weeks	Measured by the DEXA scan: o Percent fat mass (%), expressed as a percentage of the total body mass
Emotional well-being	0, 12, 24 weeks	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.
Total carbohydrates	0, 12, 24 weeks	Total carbohydrates via FFQ dietary intake parameters
Gynoid fat mass	0, 12, 24 weeks	Measured by the DEXA scan: o Gynoid fat mass (kg)
Abdominal visceral fat mass	0, 12, 24 weeks	Measured by the DEXA scan: o Abdominal visceral fat mass (g)
Hip circumference	0, 12, 24 weeks	measured by the 3D body scan: o Hip circumference (cm)
Waist to hip ratio	0, 12, 24 weeks	measured by the 3D body scan: o Waist (abdominal) to hip ratio
LDL-C	0, 12, 24 weeks	LDL-C through blood
VLDL-C	0, 12, 24 weeks	VLDL-C through blood
non-HDL-C	0, 12, 24 weeks	non-HDL-C through blood
Body Weight	0, 4, 8, 12, 16, 20, and 24 weeks	Change in body weight from week 0 to each measured follow-up visit
Physical functioning	0, 12, 24 weeks	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.
Social functioning	0, 12, 24 weeks	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.
Energy/Fatigue	0, 12, 24 weeks	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.
Total kcals	0, 12, 24 weeks	Total kcals via FFQ dietary intake parameters
Total protein	0, 12, 24 weeks	Total protein via FFQ dietary intake parameters
Abdominal circumference	0, 12, 24 weeks	measured by the 3D body scan: o Waist (abdominal) circumference (cm)
Chest circumference	0, 12, 24 weeks	measured by the 3D body scan: o Chest circumference (cm)
HbA1c	0, 12, 24 weeks	HbA1c through blood
FGF21	0, 24 weeks	FGF21 through blood
Diastolic blood pressure	0, 4, 8,12, 24 weeks	Diastolic blood pressure (mmHg)
Bodily pain	0, 12, 24 weeks	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.
Total fat	0, 12, 24 weeks	Total fat via FFQ dietary intake parameters
Healthy Eating Index (HEI) score	0, 12, 24 weeks	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.
Triglycerides	0, 12, 24 weeks	Triglycerides through blood
General health perceptions	0, 12, 24 weeks	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.
Fiber	0, 12, 24 weeks	Fiber via FFQ dietary intake parameters
AST	0, 12, 24 weeks	Changes in the chemistry profile for safety parameters
Fasting insulin	0, 12, 24 weeks	Fasting insulin through blood
Systolic blood pressure	0, 4, 8,12, 24 weeks	Systolic blood pressure (mmHg)
Total-Cholesterol	0, 12, 24 weeks	Total-C through blood
HDL-C	0, 12, 24 weeks	HDL-C through blood
Role limitations due to physical health	0, 12, 24 weeks	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.
Role limitation due to personal or emotional problems	0, 12, 24 weeks	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.

Trial Locations

Locations (1)

Biofortis Research; 🇺🇸 Addison, Illinois, United States