A Clinical Trial to Investigate the Safety and Efficacy of MB-1 on Metabolic Health in Overweight and Obese Adults

NCT07363148 | Not Yet Recruiting

• 1 other identifier: 25ARCCM01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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 and body mass index (BMI) 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.

Conditions

Obese; Overweight Adults; Obese Adults; Body Weight Control; BMI

Keywords

Arrae; MB-1; Obesity; Overweight

Outcome Measures

Primary Outcomes (1)

• The difference in change in body weight and body mass index (BMI) between MB-1 and placebo

  The difference in change in body weight and body mass index (BMI) from baseline at Day 84 between MB-1 and placebo

  Day 0 to 84

Secondary Outcomes (16)

• The difference in change in body weight and BMI between MB-1 and placebo

  Day 0 to 42

• The difference in change in anthropometric measures (waist, arm, thigh, and hip circumference) between MB-1 and placebo

  Day 0 to 42

• The difference in change in anthropometric measures (waist, arm, thigh, and hip circumference) between MB-1 and placebo

  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)

  Day 0 to 84

• The difference in change in Resting Energy Expenditure (REE), adjusted for bodyweight and body composition between MB-1 and placebo

  Day 0 to 84

Other Outcomes (3)

• Incidence of post-emergent adverse events (AE)

  Day 0 to 84

• Clinically relevant changes in heart rate (HR) after supplementation

  Day 0 to 84

• Clinically relevant changes in blood pressure (BP) after supplementation

  Day 0 to 84

Study Arms (2)

MB-1

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.

Dietary Supplement: MB-1

Placebo

EXPERIMENTAL

Placebo contains white rice flour

Other: Placebo

Interventions

MB-1 DIETARY_SUPPLEMENT

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

MB-1

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males \& females aged 18-65 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,
• 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
• Willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits
• Agrees to maintain current lifestyle habits (diet, medications, supplements, and sleep) as much as possible throughout the study
• Provided voluntary, written, informed consent to participate in the study

You may not qualify if:

• 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
• Currently taking weight loss medications or participated in a weight loss program within the past three months as assessed by the QI
• Current or history of eating disorders as assessed by the QI
• Unstable metabolic disease or chronic diseases as assessed by the QI
• Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
• Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Participants residing in the same household as another study participant unless they are enrolled consecutively (e.g. not actively enrolled at the same time)
• Type I diabetes
• Type II diabetes with HbA1c of ≥ 6.5% and/or if \< 6 months of stable medication use
• Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
• History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
• Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI

Sponsors & Collaborators

• Arrae: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B3L1, Canada

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Moulin, PhD

CONTACT

2267819094; mmoulin@kgkscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 23, 2026
• Study Start: April 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

CA (1)