The goal of this clinical trial is to investigate the safety and efficacy of MB-1 on metabolic health in overweight and obese adults. The main question it aims to answer is: What is the difference in change in body weight from baseline at Day 84 between MB-1 and placebo? Participants will be provided MB-1 or placebo and be assessed for anthropometric measurements, blood pressure, heart rate, and asked to complete appetite and satiety questionnaires and undergo a DEXA scan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Participants will be instructed to take two capsules every morning with a meal for the duration of the study starting on Day 1 until the day prior to their end of study visit.
Participants will be instructed to take two capsules every morning with a meal for the duration of the study starting on Day 1 until the day prior to their end of study visit.
KGK Science Inc.
London, Ontario, Canada
The difference in change in body weight between MB-1 and placebo
The difference in change in body weight from baseline at Day 84 between MB-1 and placebo
Time frame: Day 0 to 84
The difference in change in body weight between MB-1 and placebo
The difference in change in body weight from baseline at Day 42 between MB-1 and placebo
Time frame: Day 0 to 42
The difference in change in anthropometric measures (waist and hip circumference) between MB-1 and placebo
The difference in change in anthropometric measures (waist and hip circumference) from baseline at Days 42 between MB-1 and placebo
Time frame: Day 0 to 42
The difference in change in anthropometric measures (waist and hip circumference) between MB-1 and placebo
The difference in change in anthropometric measures (waist and hip circumference) from baseline at Day 84 between MB-1 and placebo
Time frame: Day 0 to 84
The difference in change in body composition (fat and muscle mass) between MB-1 and placebo as assessed by Dual-Energy X-Ray Absorption (DEXA)
The difference in change in body composition (fat and muscle mass) from baseline at Day 84 between MB-1 and placebo as assessed by Dual-Energy X-Ray Absorption (DEXA)
Time frame: Day 0 to 84
The difference in change in fasting blood glucose between MB-1 and placebo as assessed by fasting blood glucose
The difference in change in fasting blood glucose from baseline at Day 84 between MB-1 and placebo as assessed by fasting blood glucose
Time frame: Day 0 to 84
The difference in change in lipid profile between MB-1 and placebo
The difference in change in lipid profile: total cholesterol (TC) between MB-1 and placebo
Time frame: Day 0 to 84
The difference in change in lipid profile between MB-1 and placebo
The difference in change in lipid profile: low-density lipoprotein cholesterol (LDL-C between MB-1 and placebo
Time frame: Day 0 to 84
The difference in change in lipid profile between MB-1 and placebo
The difference in change in lipid profile: high-density lipoprotein cholesterol (HDL-C) between MB-1 and placebo
Time frame: Day 0 to 84
The difference in change in lipid profile between MB-1 and placebo
The difference in change in lipid profile: non-HDL-C between MB-1 and placebo
Time frame: Day 0 to 84
The difference in change in lipid profile between MB-1 and placebo
The difference in change in lipid profile: triglycerides (TG) between MB-1 and placebo
Time frame: Day 0 to 84
The difference in change in lipid profile between MB-1 and placebo
The difference in change in lipid profile: TG/HDL-C, TC/HDL-C and LDL-C/HDL-C between MB-1 and placebo
Time frame: Day 0 to 84
The difference in change in ratings of appetite, satiety, and cravings between MB-1 and placebo as assessed by the weekly Appetite, Satiety and Cravings Likert scales.
The difference in change in ratings of appetite, satiety, and cravings between MB-1 and placebo as assessed by the weekly Appetite, Satiety and Cravings Likert scales.
Time frame: Day 0 to 84
The difference in change in ratings of energy between MB-1 and placebo as assessed by the weekly Energy Likert scale.
The difference in change in ratings of energy from baseline at Day 84 between MB-1 and placebo as assessed by the weekly Energy Likert scale.
Time frame: Day 0 to 84
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