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Status unknownNCT06296251Updated May 16, 2024

Dietary Supplementation on Body Fat Composition

An interventional study of Placebo treatment and Plant derived phenolics in Dyslipidemias and Pre-diabetes, sponsored by Brightseed. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Brightseed · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Dyslipidemias
  • Pre-diabetes
03

In context

Dyslipidemias

1,101 studies on the registry are indexed under Dyslipidemias; 161 are open to participants now.

This study's planned enrollment of 150 is above the median of 100 across 861 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Brightseed is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
150 participants (estimated)

Study arms

  • Placebo comparator
    Placebo treatment

    Placebo treatment (Microcrystaline cellulose): 1 capsule/day

    Other: Placebo treatment

  • 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

  • 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

Interventions

  • OtherPlacebo treatment

    Microcrystaline cellulose (MCC)

  • Dietary supplementPlant derived phenolics

    Dietary supplement containing plant derived phenolics

06

What researchers measure

Primary outcomes

  1. Body fat mass

    Body fat mass (kg) change by the DEXA scan.

    Time frame: 0, 12, 24 weeks

Secondary outcomes

  1. Body composition

    Measured by the DEXA scan: o Percent fat mass (%), expressed as a percentage of the total body mass

    Time frame: 0, 12, 24 weeks

  2. Android fat mass

    Measured by the DEXA scan: o Android fat mass (kg)

    Time frame: 0, 12, 24 weeks

  3. Gynoid fat mass

    Measured by the DEXA scan: o Gynoid fat mass (kg)

    Time frame: 0, 12, 24 weeks

  4. Abdominal visceral fat mass

    Measured by the DEXA scan: o Abdominal visceral fat mass (g)

    Time frame: 0, 12, 24 weeks

  5. Abdominal circumference

    measured by the 3D body scan: o Waist (abdominal) circumference (cm)

    Time frame: 0, 12, 24 weeks

  6. Hip circumference

    measured by the 3D body scan: o Hip circumference (cm)

    Time frame: 0, 12, 24 weeks

  7. Chest circumference

    measured by the 3D body scan: o Chest circumference (cm)

    Time frame: 0, 12, 24 weeks

  8. Upper thigh circumference

    measured by the 3D body scan: o Upper thigh (average of left and right thighs) circumference (cm)

    Time frame: 0, 12, 24 weeks

  9. Upper arm circumference

    measured by the 3D body scan: o Upper arm bicep (average of left and right arms) circumference (cm)

    Time frame: 0, 12, 24 weeks

  10. Waist to hip ratio

    measured by the 3D body scan: o Waist (abdominal) to hip ratio

    Time frame: 0, 12, 24 weeks

  11. Fasting glucose

    Fasting glucose through blood

    Time frame: 0, 12, 24 weeks

  12. Fasting insulin

    Fasting insulin through blood

    Time frame: 0, 12, 24 weeks

  13. HbA1c

    HbA1c through blood

    Time frame: 0, 12, 24 weeks

  14. FGF21

    FGF21 through blood

    Time frame: 0, 24 weeks

  15. Systolic blood pressure

    Systolic blood pressure (mmHg)

    Time frame: 0, 4, 8,12, 24 weeks

  16. Diastolic blood pressure

    Diastolic blood pressure (mmHg)

    Time frame: 0, 4, 8,12, 24 weeks

  17. Total-Cholesterol

    Total-C through blood

    Time frame: 0, 12, 24 weeks

  18. HDL-C

    HDL-C through blood

    Time frame: 0, 12, 24 weeks

  19. LDL-C

    LDL-C through blood

    Time frame: 0, 12, 24 weeks

  20. VLDL-C

    VLDL-C through blood

    Time frame: 0, 12, 24 weeks

  21. non-HDL-C

    non-HDL-C through blood

    Time frame: 0, 12, 24 weeks

  22. Triglycerides

    Triglycerides through blood

    Time frame: 0, 12, 24 weeks

  23. Body Weight

    Change in body weight from week 0 to each measured follow-up visit

    Time frame: 0, 4, 8, 12, 16, 20, and 24 weeks

  24. 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.

    Time frame: 0, 12, 24 weeks

  25. 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.

    Time frame: 0, 12, 24 weeks

  26. 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.

    Time frame: 0, 12, 24 weeks

  27. 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.

    Time frame: 0, 12, 24 weeks

  28. 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.

    Time frame: 0, 12, 24 weeks

  29. 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.

    Time frame: 0, 12, 24 weeks

  30. 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.

    Time frame: 0, 12, 24 weeks

  31. 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.

    Time frame: 0, 12, 24 weeks

  32. Total kcals

    Total kcals via FFQ dietary intake parameters

    Time frame: 0, 12, 24 weeks

  33. Total fat

    Total fat via FFQ dietary intake parameters

    Time frame: 0, 12, 24 weeks

  34. Total protein

    Total protein via FFQ dietary intake parameters

    Time frame: 0, 12, 24 weeks

  35. Total carbohydrates

    Total carbohydrates via FFQ dietary intake parameters

    Time frame: 0, 12, 24 weeks

  36. Fiber

    Fiber via FFQ dietary intake parameters

    Time frame: 0, 12, 24 weeks

  37. 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.

    Time frame: 0, 12, 24 weeks

  38. ALT

    Changes in the chemistry profile for safety parameters

    Time frame: 0, 12, 24 weeks

  39. AST

    Changes in the chemistry profile for safety parameters

    Time frame: 0, 12, 24 weeks

07

Study locations

1 of 1 sites recruiting
  • Biofortis Research
    Addison, Illinois 60101, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06296251
Lead sponsor
Brightseed
Responsible party
Sponsor
First posted
Mar 6, 2024
Start date
Apr 18, 2024
Primary completion
Dec 27, 2024 (estimated)
Completion
Feb 27, 2025 (estimated)
Last update
May 16, 2024

Study contacts

Doug Bolster
Contact
dbolster@brightseedbio.com
(415) 965-7778

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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