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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
Microcrystaline cellulose (MCC)
Dietary supplement containing plant derived phenolics
Biofortis Research
Addison, Illinois, United States
RECRUITINGBody fat mass
Body fat mass (kg) change by the DEXA scan.
Time frame: 0, 12, 24 weeks
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
Android fat mass
Measured by the DEXA scan: o Android fat mass (kg)
Time frame: 0, 12, 24 weeks
Gynoid fat mass
Measured by the DEXA scan: o Gynoid fat mass (kg)
Time frame: 0, 12, 24 weeks
Abdominal visceral fat mass
Measured by the DEXA scan: o Abdominal visceral fat mass (g)
Time frame: 0, 12, 24 weeks
Abdominal circumference
measured by the 3D body scan: o Waist (abdominal) circumference (cm)
Time frame: 0, 12, 24 weeks
Hip circumference
measured by the 3D body scan: o Hip circumference (cm)
Time frame: 0, 12, 24 weeks
Chest circumference
measured by the 3D body scan: o Chest circumference (cm)
Time frame: 0, 12, 24 weeks
Upper thigh circumference
measured by the 3D body scan: o Upper thigh (average of left and right thighs) circumference (cm)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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)
Time frame: 0, 12, 24 weeks
Waist to hip ratio
measured by the 3D body scan: o Waist (abdominal) to hip ratio
Time frame: 0, 12, 24 weeks
Fasting glucose
Fasting glucose through blood
Time frame: 0, 12, 24 weeks
Fasting insulin
Fasting insulin through blood
Time frame: 0, 12, 24 weeks
HbA1c
HbA1c through blood
Time frame: 0, 12, 24 weeks
FGF21
FGF21 through blood
Time frame: 0, 24 weeks
Systolic blood pressure
Systolic blood pressure (mmHg)
Time frame: 0, 4, 8,12, 24 weeks
Diastolic blood pressure
Diastolic blood pressure (mmHg)
Time frame: 0, 4, 8,12, 24 weeks
Total-Cholesterol
Total-C through blood
Time frame: 0, 12, 24 weeks
HDL-C
HDL-C through blood
Time frame: 0, 12, 24 weeks
LDL-C
LDL-C through blood
Time frame: 0, 12, 24 weeks
VLDL-C
VLDL-C through blood
Time frame: 0, 12, 24 weeks
non-HDL-C
non-HDL-C through blood
Time frame: 0, 12, 24 weeks
Triglycerides
Triglycerides through blood
Time frame: 0, 12, 24 weeks
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
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
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
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
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
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
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
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
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
Total kcals
Total kcals via FFQ dietary intake parameters
Time frame: 0, 12, 24 weeks
Total fat
Total fat via FFQ dietary intake parameters
Time frame: 0, 12, 24 weeks
Total protein
Total protein via FFQ dietary intake parameters
Time frame: 0, 12, 24 weeks
Total carbohydrates
Total carbohydrates via FFQ dietary intake parameters
Time frame: 0, 12, 24 weeks
Fiber
Fiber via FFQ dietary intake parameters
Time frame: 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.
Time frame: 0, 12, 24 weeks
ALT
Changes in the chemistry profile for safety parameters
Time frame: 0, 12, 24 weeks
AST
Changes in the chemistry profile for safety parameters
Time frame: 0, 12, 24 weeks