DyslipidemiasNCT06296251
Dietary Supplementation on Body Fat Composition
A study testing Plant derived phenolics in people with Dyslipidemias and Pre-diabetes, run by Brightseed at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Pre-diabetes
- What is being tested?
- Plant derived phenolics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2024to 27 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, ≥18 years of age at visit 1 (week -1).
- Body mass index (BMI) of ≥28.0 kg/m2 to <35.0 kg/m2 at visit 1 (week -1).
- 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
Show all 12Show fewer
- 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.
- 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.
- 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.
- 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.
Who cannot join
- Weight loss or gain ≥4.5 kg within 90 days of visit 1.
- Use of weight loss medications within 90 days of visit 1
- History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes.
- 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.
- History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator.
- History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
Show all 21Show fewer
- Current medical diagnosis of type 1 or type 2 diabetes mellitus.
- HbA1c ≥48 mmol/mol (6.5%) as measured at visit 1.
- History of a chronic gastrointestinal disorder, such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).
- History of liver disease with exception of non-alcoholic fatty livery disease (NAFLD).
- 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.
- 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.
- Habitual use (i.e., daily) of marijuana and hemp products including CBD products within 30 days of visit 1.
- History or presence of cancer (including any malignant GI polyps) within 2 years of visit 1, except for non-melanoma skin cancer.
- Unstable use of thyroid hormone replacement medication, where stable use is defined as the same dose for ≥90 days prior to visit 1.
- Known intolerance or sensitivity to any ingredients in the study products.
- Exposure to any non-registered drug product within 4 weeks prior to visit 1.
- 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.
- 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.
- 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).
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Biofortis Research
Addison, Illinois, 60101
About this study
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
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.
- Conditions
- Dyslipidemias, Pre-diabetes
- Being tested
- Placebo treatment, Plant derived phenolics
- Medical subject headings
- Dyslipidemias, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo treatmentOther
Microcrystaline cellulose (MCC)
Plant derived phenolicsDietary supplement
Dietary supplement containing plant derived phenolics
| Study group | Role | What they receive |
|---|---|---|
| Placebo treatment | Placebo comparator | Placebo treatment (Microcrystaline cellulose): 1 capsule/day Receives: Other: Placebo treatment |
| Active low dose of plant derived phenolics | Active comparator | Active low dose of plant derived phenolics via 1 capsule/day Receives: Dietary Supplement: Plant derived phenolics |
| Active high dose of plant derived phenolics | Active comparator | Active high dose of plant derived phenolics via 1 capsule/day Receives: Dietary Supplement: Plant derived phenolics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat mass
Body fat mass (kg) change by the DEXA scan.
Measured: 0, 12, 24 weeks
Secondary outcomes (39)
Body composition
Measured by the DEXA scan:
- Percent fat mass (%), expressed as a percentage of the total body mass
Measured: 0, 12, 24 weeks
Android fat mass
Measured by the DEXA scan:
- Android fat mass (kg)
Measured: 0, 12, 24 weeks
Gynoid fat mass
Measured by the DEXA scan:
- Gynoid fat mass (kg)
Measured: 0, 12, 24 weeks
Abdominal visceral fat mass
Measured by the DEXA scan:
- Abdominal visceral fat mass (g)
Measured: 0, 12, 24 weeks
Abdominal circumference
measured by the 3D body scan:
- Waist (abdominal) circumference (cm)
Measured: 0, 12, 24 weeks
Hip circumference
measured by the 3D body scan:
- Hip circumference (cm)
Measured: 0, 12, 24 weeks
Chest circumference
measured by the 3D body scan:
- Chest circumference (cm)
Measured: 0, 12, 24 weeks
Upper thigh circumference
measured by the 3D body scan:
- Upper thigh (average of left and right thighs) circumference (cm)
Measured: 0, 12, 24 weeks
Upper arm circumference
measured by the 3D body scan:
- Upper arm bicep (average of left and right arms) circumference (cm)
Measured: 0, 12, 24 weeks
Waist to hip ratio
measured by the 3D body scan:
- Waist (abdominal) to hip ratio
Measured: 0, 12, 24 weeks
Fasting glucose
Fasting glucose through blood
Measured: 0, 12, 24 weeks
Fasting insulin
Fasting insulin through blood
Measured: 0, 12, 24 weeks
HbA1c
HbA1c through blood
Measured: 0, 12, 24 weeks
FGF21
FGF21 through blood
Measured: 0, 24 weeks
Systolic blood pressure
Systolic blood pressure (mmHg)
Measured: 0, 4, 8,12, 24 weeks
Diastolic blood pressure
Diastolic blood pressure (mmHg)
Measured: 0, 4, 8,12, 24 weeks
Total-Cholesterol
Total-C through blood
Measured: 0, 12, 24 weeks
HDL-C
HDL-C through blood
Measured: 0, 12, 24 weeks
LDL-C
LDL-C through blood
Measured: 0, 12, 24 weeks
VLDL-C
VLDL-C through blood
Measured: 0, 12, 24 weeks
non-HDL-C
non-HDL-C through blood
Measured: 0, 12, 24 weeks
Triglycerides
Triglycerides through blood
Measured: 0, 12, 24 weeks
Body Weight
Change in body weight from week 0 to each measured follow-up visit
Measured: 0, 4, 8, 12, 16, 20, and 24 weeks
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.
Measured: 0, 12, 24 weeks
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.
Measured: 0, 12, 24 weeks
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.
Measured: 0, 12, 24 weeks
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.
Measured: 0, 12, 24 weeks
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.
Measured: 0, 12, 24 weeks
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.
Measured: 0, 12, 24 weeks
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.
Measured: 0, 12, 24 weeks
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.
Measured: 0, 12, 24 weeks
Total kcals
Total kcals via FFQ dietary intake parameters
Measured: 0, 12, 24 weeks
Total fat
Total fat via FFQ dietary intake parameters
Measured: 0, 12, 24 weeks
Total protein
Total protein via FFQ dietary intake parameters
Measured: 0, 12, 24 weeks
Total carbohydrates
Total carbohydrates via FFQ dietary intake parameters
Measured: 0, 12, 24 weeks
Fiber
Fiber via FFQ dietary intake parameters
Measured: 0, 12, 24 weeks
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.
Measured: 0, 12, 24 weeks
ALT
Changes in the chemistry profile for safety parameters
Measured: 0, 12, 24 weeks
AST
Changes in the chemistry profile for safety parameters
Measured: 0, 12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start18 Apr 2024
- Primary completion27 Dec 2024 (estimated)
- Study completion27 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brightseed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296251
- Sponsor's protocol ID
- BIO-2313
- Status last verified
- May 2024
- First submitted
- 29 Feb 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06296251
- Acronym / sponsor ID
- BIO-2313
- Conditions
- Dyslipidemias, Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- BrightseedIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 27 Dec 2024 (estimated)
- Study completion
- 27 Feb 2025 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo treatment | Placebo comparator | Other: Placebo treatmentPlacebo treatment (Microcrystaline cellulose): 1 capsule/day |
| Active low dose of plant derived phenolics | Active comparator | Dietary Supplement: Plant derived phenolicsActive low dose of plant derived phenolics via 1 capsule/day |
| Active high dose of plant derived phenolics | Active comparator | Dietary Supplement: Plant derived phenolicsActive high dose of plant derived phenolics via 1 capsule/day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female, ≥18 years of age at visit 1 (week -1).
- Body mass index (BMI) of ≥28.0 kg/m2 to <35.0 kg/m2 at visit 1 (week -1).
- At least one of the following comorbidities based on blood draws at visit 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 during the study period.
- 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.
Key exclusion criteria (21 listed)
- Weight loss or gain ≥4.5 kg within 90 days of visit 1.
- Use of weight loss medications within 90 days of visit 1
- History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes.
- 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.
- History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo treatmentMicrocrystaline cellulose (MCC) | Other | Placebo treatment |
| Plant derived phenolicsDietary supplement containing plant derived phenolics | Dietary supplement | Active high dose of plant derived phenolics, Active low dose of plant derived phenolics |
Primary outcome
Body fat mass
Time frame: 0, 12, 24 weeks
Body fat mass (kg) change by the DEXA scan.
39 secondary outcomes
Body composition
Time frame: 0, 12, 24 weeks
Android fat mass
Time frame: 0, 12, 24 weeks
Gynoid fat mass
Time frame: 0, 12, 24 weeks
Abdominal visceral fat mass
Time frame: 0, 12, 24 weeks
Abdominal circumference
Time frame: 0, 12, 24 weeks
Hip circumference
Time frame: 0, 12, 24 weeks
Chest circumference
Time frame: 0, 12, 24 weeks
Upper thigh circumference
Time frame: 0, 12, 24 weeks
Upper arm circumference
Time frame: 0, 12, 24 weeks
Waist to hip ratio
Time frame: 0, 12, 24 weeks
Fasting glucose
Time frame: 0, 12, 24 weeks
Fasting insulin
Time frame: 0, 12, 24 weeks
HbA1c
Time frame: 0, 12, 24 weeks
FGF21
Time frame: 0, 24 weeks
Systolic blood pressure
Time frame: 0, 4, 8,12, 24 weeks
Diastolic blood pressure
Time frame: 0, 4, 8,12, 24 weeks
Total-Cholesterol
Time frame: 0, 12, 24 weeks
HDL-C
Time frame: 0, 12, 24 weeks
LDL-C
Time frame: 0, 12, 24 weeks
VLDL-C
Time frame: 0, 12, 24 weeks
non-HDL-C
Time frame: 0, 12, 24 weeks
Triglycerides
Time frame: 0, 12, 24 weeks
Body Weight
Time frame: 0, 4, 8, 12, 16, 20, and 24 weeks
Physical functioning
Time frame: 0, 12, 24 weeks
Bodily pain
Time frame: 0, 12, 24 weeks
Role limitations due to physical health
Time frame: 0, 12, 24 weeks
Role limitation due to personal or emotional problems
Time frame: 0, 12, 24 weeks
Emotional well-being
Time frame: 0, 12, 24 weeks
Social functioning
Time frame: 0, 12, 24 weeks
Energy/Fatigue
Time frame: 0, 12, 24 weeks
General health perceptions
Time frame: 0, 12, 24 weeks
Total kcals
Time frame: 0, 12, 24 weeks
Total fat
Time frame: 0, 12, 24 weeks
Total protein
Time frame: 0, 12, 24 weeks
Total carbohydrates
Time frame: 0, 12, 24 weeks
Fiber
Time frame: 0, 12, 24 weeks
Healthy Eating Index (HEI) score
Time frame: 0, 12, 24 weeks
ALT
Time frame: 0, 12, 24 weeks
AST
Time frame: 0, 12, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Related trials for Dyslipidemias
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingPhase 1
A Study to Evaluate COR-1004 in Adult Volunteers.
Hyperlipidemia
Active, not recruitingPhase 3
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Lipodystrophy, Diabetes
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant derived phenolics in people with Dyslipidemias and Pre-diabetes, run by Brightseed at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doug Bolster ((415) 965-7778, dbolster@brightseedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body fat mass (time frame: 0, 12, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.