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MB-1 Impact on Metabolic Health in Overweight and Obese Adults

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What is being tested

MB-1

+ Placebo
Dietary Supplement
Other
Who is being recruted

Body Weight
+5

+ Nutrition Disorders
+ Nutritional and Metabolic Diseases
From 18 to 65 Years
+38 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2026
See protocol details

Summary

Principal SponsorArrae
Study ContactMarc Moulin, PhD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2026Actual date on which the first participant was enrolled.

This clinical trial focuses on exploring the safety and efficacy of a treatment called MB-1 in improving metabolic health among adults who are overweight or obese. The primary aim is to understand if MB-1 can lead to significant changes in body weight and Body Mass Index (BMI) when compared to a placebo. This study is important as it could potentially offer a new approach to manage weight and related health issues in overweight and obese individuals, thereby addressing a common health challenge. In this trial, participants are given either MB-1 or a placebo. Throughout the study, various measurements are taken such as body weight, BMI, blood pressure, and heart rate. Participants are also asked to complete questionnaires about their appetite and feelings of fullness, and undergo a DEXA scan, which is a type of X-ray that measures body composition. The study's main outcome measure is the difference in body weight and BMI changes from the start of the trial to Day 84 between the MB-1 and placebo groups.

Official TitleA Randomized, Double-blind, Placebo-controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of MB-1 on Metabolic Health in Overweight and Obese Adults 
NCT07363148
Principal SponsorArrae
Study ContactMarc Moulin, PhD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
100 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Body Weight
Nutrition Disorders
Nutritional and Metabolic Diseases
Obesity
Signs and Symptoms
Pathological Conditions, Signs and Symptoms
Overnutrition
Overweight
Criteria
9 inclusion criteria required to participate
Males & females aged 18-65 years, inclusive
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, Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically-approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include: 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), Double-barrier method, Intrauterine devices, Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s), Vasectomy of partner at least 6 months prior to screening, Abstinence and agrees to use contraception if planning on becoming sexually active during the study
Stable body weight defined as a <5% change in body weight in the three months prior to baseline as assessed by the QI
Abdominal obesity: Waist circumference of > 94 cm (37 inches) in men and > 80 cm (31.5 inches) in women

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29 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
MB-1 contains African mango seed (Irvingia Gabonensis), Cissus leaf (Cissus quadrangularis) extract, Grains of Paradise (Aframomum melegueta), Bifidobacterium Lactis (B. lactis) B420, Green tea extract (standardized to 92 ± 2.5 % caffeine), Green tea extract (Camellia sinensis), Vitamin B6, and Chromium Picolinate.

Participants will be instructed to take two capsules every morning with a meal for the duration of the study starting on Day 1.
Group II
Experimental
Placebo contains white rice flour

Participants will be instructed to take two capsules every morning with a meal for the duration of the study starting on Day 1.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
KGK Science Inc.London, CanadaSee the location
Recruiting soonOne Study Center