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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo treatment | Placebo Comparator | Placebo treatment (Microcrystaline cellulose): 1 capsule/day |
|
| Active low dose of plant derived phenolics | Active Comparator | Active low dose of plant derived phenolics via 1 capsule/day |
|
| Active high dose of plant derived phenolics | Active Comparator | Active high dose of plant derived phenolics via 1 capsule/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo treatment | Other | Microcrystaline cellulose (MCC) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Body fat mass | Body fat mass (kg) change by the DEXA scan. | 0, 12, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Measured by the DEXA scan: o Percent fat mass (%), expressed as a percentage of the total body mass | 0, 12, 24 weeks |
| Android fat mass | Measured by the DEXA scan: o Android fat mass (kg) |
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Inclusion Criteria:
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)
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Doug Bolster | Contact | (415) 965-7778 | dbolster@brightseedbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis Research | Recruiting | Addison | Illinois | 60101 | United States |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006943 | Hyperglycemia |
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| Plant derived phenolics |
| Dietary Supplement |
Dietary supplement containing plant derived phenolics |
|
| 0, 12, 24 weeks |
| Gynoid fat mass | Measured by the DEXA scan: o Gynoid fat mass (kg) | 0, 12, 24 weeks |
| Abdominal visceral fat mass | Measured by the DEXA scan: o Abdominal visceral fat mass (g) | 0, 12, 24 weeks |
| Abdominal circumference | measured by the 3D body scan: o Waist (abdominal) circumference (cm) | 0, 12, 24 weeks |
| Hip circumference | measured by the 3D body scan: o Hip circumference (cm) | 0, 12, 24 weeks |
| Chest circumference | measured by the 3D body scan: o Chest circumference (cm) | 0, 12, 24 weeks |
| Upper thigh circumference | measured by the 3D body scan: o Upper thigh (average of left and right thighs) circumference (cm) | 0, 12, 24 weeks |
| Upper arm circumference | measured by the 3D body scan: o Upper arm bicep (average of left and right arms) circumference (cm) | 0, 12, 24 weeks |
| Waist to hip ratio | measured by the 3D body scan: o Waist (abdominal) to hip ratio | 0, 12, 24 weeks |
| Fasting glucose | Fasting glucose through blood | 0, 12, 24 weeks |
| Fasting insulin | Fasting insulin through blood | 0, 12, 24 weeks |
| HbA1c | HbA1c through blood | 0, 12, 24 weeks |
| FGF21 | FGF21 through blood | 0, 24 weeks |
| Systolic blood pressure | Systolic blood pressure (mmHg) | 0, 4, 8,12, 24 weeks |
| Diastolic blood pressure | Diastolic blood pressure (mmHg) | 0, 4, 8,12, 24 weeks |
| Total-Cholesterol | Total-C through blood | 0, 12, 24 weeks |
| HDL-C | HDL-C through blood | 0, 12, 24 weeks |
| LDL-C | LDL-C through blood | 0, 12, 24 weeks |
| VLDL-C | VLDL-C through blood | 0, 12, 24 weeks |
| non-HDL-C | non-HDL-C through blood | 0, 12, 24 weeks |
| Triglycerides | Triglycerides through blood | 0, 12, 24 weeks |
| Body Weight | Change in body weight from week 0 to each measured follow-up visit | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 0, 12, 24 weeks |
| Total kcals | Total kcals via FFQ dietary intake parameters | 0, 12, 24 weeks |
| Total fat | Total fat via FFQ dietary intake parameters | 0, 12, 24 weeks |
| Total protein | Total protein via FFQ dietary intake parameters | 0, 12, 24 weeks |
| Total carbohydrates | Total carbohydrates via FFQ dietary intake parameters | 0, 12, 24 weeks |
| Fiber | Fiber via FFQ dietary intake parameters | 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. | 0, 12, 24 weeks |
| ALT | Changes in the chemistry profile for safety parameters | 0, 12, 24 weeks |
| AST | Changes in the chemistry profile for safety parameters | 0, 12, 24 weeks |
| D044882 | Glucose Metabolism Disorders |