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

Официальное название

A 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

Обзор

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.

Вмешательства

• Пищевая добавка MB-1
  Participants 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.
• Другое Placebo
  Participants 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.

Первичные конечные точки

• The difference in change in body weight between MB-1 and placebo [Срок оценки: Day 0 to 84]

Вторичные конечные точки (12)

• The difference in change in body weight between MB-1 and placebo [Срок оценки: Day 0 to 42]
• The difference in change in anthropometric measures (waist and hip circumference) between MB-1 and placebo [Срок оценки: Day 0 to 42]
• The difference in change in anthropometric measures (waist and hip circumference) between MB-1 and placebo [Срок оценки: 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) [Срок оценки: Day 0 to 84]
• The difference in change in fasting blood glucose between MB-1 and placebo as assessed by fasting blood glucose [Срок оценки: Day 0 to 84]
• The difference in change in lipid profile between MB-1 and placebo [Срок оценки: Day 0 to 84]
• The difference in change in lipid profile between MB-1 and placebo [Срок оценки: Day 0 to 84]
• The difference in change in lipid profile between MB-1 and placebo [Срок оценки: Day 0 to 84]
• The difference in change in lipid profile between MB-1 and placebo [Срок оценки: Day 0 to 84]
• The difference in change in lipid profile between MB-1 and placebo [Срок оценки: Day 0 to 84]
• The difference in change in lipid profile between MB-1 and placebo [Срок оценки: Day 0 to 84]
• The difference in change in ratings of appetite, satiety, and cravings between MB-1 and placebo as assessed by the weekly Appetite, Satiety and Cravings Likert scales. [Срок оценки: Day 0 to 84]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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
• Chronic use of cannabinoid products (>2 times/week) as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
• Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
• Alcohol intake average of >2 standard drinks per day as assessed by the QI
• Alcohol or drug abuse within the last 12 months
• Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Section 7.3)
• Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
• Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
• Individuals who are unable to give informed consent
• Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• KGK Science Inc. — London

Идентификаторы

NCT: NCT07363148 · 25ARCCM01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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