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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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, 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
• Healthy as determined by medical history as assessed by Qualified Investigator (QI)

🚫 You may not be able to join 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 or Type II diabetes
• 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
• Self reported confirmation of glaucoma
• Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
• Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
• Individuals with an autoimmune disease or are immune compromised as assessed by the QI
• Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
• Self-reported confirmation of blood/bleeding disorders as assessed by the QI

+ 9 more criteria — see the full checklist in the app.

Where this trial is running

• KGK Science Inc., London, Ontario, Canada

Who to contact

Marc Moulin, PhD · 2267819094 · mmoulin@kgkscience.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07363148.