A Clinical Trial to Investigate the Safety and Efficacy of MB-1 on Metabolic Health in Overweight and Obese Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorArrae
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males & females aged 18-50 years, inclusive
BMI of 25.0 to ≤ 34.9 kg/m²
Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Disqualifiers
Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
Allergy, sensitivity, or intolerance preventing consumption of the investigational product or placebo ingredients
Gastric bypass surgery or other surgeries to induce weight loss
Metal implants or other physical characteristics/limitations that may affect DEXA scan results as assessed by the QI
Trial design
Design model
Parallel
Treatments tested in this trial
MB-1
Dietary supplementParticipants 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.
Placebo
Other interventionParticipants 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: MB-1Experimental treatment 1 intervention
Group B: PlaceboExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 84Secondary outcomes
1
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 422
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 423
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 844
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 84Other outcomes
1
Incidence of post-emergent adverse events (AE)
Incidence of post-emergent adverse events (AE)
Time frame
Day 0 to 842
Clinically relevant changes in heart rate (HR) after supplementation
Clinically relevant changes in heart rate (HR) after supplementation
Time frame
Day 0 to 843
Clinically relevant changes in blood pressure (BP) after supplementation
Clinically relevant changes in blood pressure (BP) after supplementation
Time frame
Day 0 to 844
Clinically relevant changes in liver function
Clinically relevant changes in liver function.
Time frame
Day 0 to 84Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Arrae
Lead sponsor
KGK Science Inc.
Collaborator
Source ClinicalTrials.gov