Dietary Supplementation on Body Fat Composition

Last updated: May 13, 2024
Sponsor: Brightseed
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes (Pediatric)

Treatment

Placebo treatment

Plant derived phenolics

Clinical Study ID

NCT06296251
BIO-2313
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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, wherestable use is defined as the same dose for at least 90 d prior to visit1.

  1. 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 duringthe study period.

  2. Willing to maintain a stable intake of current dietary supplements and medicationsnot specifically listed as exclusionary or deemed to interfere with study outcomesthroughout study duration.

  3. Willing to adhere to all study procedures and signs forms providing informed consentto participate in the study and authorization to release relevant protected healthinformation to the Clinical Investigator.

Exclusion

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 theInvestigator, are likely to markedly affect weight loss or appetite within 30 daysof visit 1.

  5. History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by theInvestigator.

  6. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or bingeeating) 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 ormalabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseasesare 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 isdefined as the same dose for ≥90 days prior to visit 1.

  12. Uncontrolled stage 2 hypertension (systolic blood pressure ≥140 mm Hg or diastolicblood 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 thestudy per Investigator's discretion. Stable dose is defined as same dose for >90days.

  13. Habitual use (i.e., daily) of marijuana and hemp products including CBD productswithin 30 days of visit 1.

  14. History or presence of cancer (including any malignant GI polyps) within 2 years ofvisit 1, except for non-melanoma skin cancer.

  15. Unstable use of thyroid hormone replacement medication, where stable use is definedas 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 ofvisit 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 medicallyapproved form of contraception throughout the study period. The method ofcontraception must be recorded in the source document.

  20. Recent history (within 12 months of visit 1) of alcohol or substance abuse. Alcoholabuse is defined as >14 drinks per week (1 drink = 12 oz. beer, 5 oz. wine, or 1½oz. distilled spirits).

  21. Any condition the Investigator believes would interfere with his or her ability toprovide informed consent, comply with the study protocol, or which might confoundthe interpretation of the study results or put the person at undue risk. *If aninfection occurs during the study period, test visits will be rescheduled untilsigns and symptoms have resolved (at the discretion of the Clinical Investigator) atleast 5 days prior to the scheduled study visits.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Placebo treatment
Phase:
Study Start date:
April 18, 2024
Estimated Completion Date:
February 27, 2025

Connect with a study center

  • Biofortis Research

    Addison, Illinois 60101
    United States

    Active - Recruiting

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