Clinical trial NCT06296251: Dietary Supplementation on Body Fat Composition
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dyslipidemias
Pre-diabetes
Lead sponsor: Brightseed
Sponsor class: INDUSTRY
First posted: 2024-03-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Body fat mass
timeFrame: 0, 12, 24 weeks
Secondary outcomes:
measure: Body composition
timeFrame: 0, 12, 24 weeks
measure: Android fat mass
timeFrame: 0, 12, 24 weeks
measure: Gynoid fat mass
timeFrame: 0, 12, 24 weeks
measure: Abdominal visceral fat mass
timeFrame: 0, 12, 24 weeks
measure: Abdominal circumference
timeFrame: 0, 12, 24 weeks
measure: Hip circumference
timeFrame: 0, 12, 24 weeks
measure: Chest circumference
timeFrame: 0, 12, 24 weeks
measure: Upper thigh circumference
timeFrame: 0, 12, 24 weeks
measure: Upper arm circumference
timeFrame: 0, 12, 24 weeks
measure: Waist to hip ratio
timeFrame: 0, 12, 24 weeks
measure: Fasting glucose
timeFrame: 0, 12, 24 weeks
measure: Fasting insulin
timeFrame: 0, 12, 24 weeks
measure: HbA1c
timeFrame: 0, 12, 24 weeks
measure: FGF21
timeFrame: 0, 24 weeks
measure: Systolic blood pressure
timeFrame: 0, 4, 8,12, 24 weeks
measure: Diastolic blood pressure
timeFrame: 0, 4, 8,12, 24 weeks
measure: Total-Cholesterol
timeFrame: 0, 12, 24 weeks
measure: HDL-C
timeFrame: 0, 12, 24 weeks
measure: LDL-C
timeFrame: 0, 12, 24 weeks
measure: VLDL-C
timeFrame: 0, 12, 24 weeks
measure: non-HDL-C
timeFrame: 0, 12, 24 weeks
measure: Triglycerides
timeFrame: 0, 12, 24 weeks
measure: Body Weight
timeFrame: 0, 4, 8, 12, 16, 20, and 24 weeks
measure: Physical functioning
timeFrame: 0, 12, 24 weeks
measure: Bodily pain
timeFrame: 0, 12, 24 weeks
measure: Role limitations due to physical health
timeFrame: 0, 12, 24 weeks
measure: Role limitation due to personal or emotional problems
timeFrame: 0, 12, 24 weeks
measure: Emotional well-being
timeFrame: 0, 12, 24 weeks
measure: Social functioning
timeFrame: 0, 12, 24 weeks
measure: Energy/Fatigue
timeFrame: 0, 12, 24 weeks
measure: General health perceptions
timeFrame: 0, 12, 24 weeks
measure: Total kcals
timeFrame: 0, 12, 24 weeks
measure: Total fat
timeFrame: 0, 12, 24 weeks
measure: Total protein
timeFrame: 0, 12, 24 weeks
measure: Total carbohydrates
timeFrame: 0, 12, 24 weeks
measure: Fiber
timeFrame: 0, 12, 24 weeks
measure: Healthy Eating Index (HEI) score
timeFrame: 0, 12, 24 weeks
measure: ALT
timeFrame: 0, 12, 24 weeks
measure: AST
timeFrame: 0, 12, 24 weeks
Other outcomes:
Locations:
city: Addison
country: United States
facility: Biofortis Research
state: Illinois
Study officials:
References: