Recruiting soon

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

What is being tested

MB-1

+ Placebo

Dietary SupplementOther

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 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2026

Actual 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 28, 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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

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

Show More Criteria

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

Show More Criteria

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.

Group II

Experimental

Placebo contains white rice flour

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, CanadaOpen KGK Science Inc. in Google Maps

Recruiting soonOne Study Center