ObeseNCT07363148
A Clinical Trial to Investigate the Safety and Efficacy of MB-1 on Metabolic Health in Overweight and Obese Adults
A study testing MB-1 in people with Obese and Overweight Adults, run by Arrae at 1 site in Canada.
Trial 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 from baseline at Day 84 between MB-1 and placebo? Participants will be provided MB-1 or placebo… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obese, Overweight Adults, Obese Adults
- What is being tested?
- MB-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 5 Aug 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
KGK Science Inc.
London, Ontario, N6B3L1
Erin Lewis, PhD, 519-438-9374 x 248, elewis@kgkscience.com
David Crowley, MD
About this study
Official title: 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
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.
- Conditions
- Obese, Overweight Adults, Obese Adults, Body Weight Control, BMI
- Being tested
- MB-1, Placebo
- Keywords
- Arrae, MB-1, Obesity, Overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB-1Dietary supplement
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: MB-1 |
| Placebo | Experimental | Placebo contains white rice flour Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in change in body weight between MB-1 and placebo
The difference in change in body weight from baseline at Day 84 between MB-1 and placebo
Measured: Day 0 to 84
Secondary outcomes (13)
The difference in change in body weight between MB-1 and placebo
The difference in change in body weight from baseline at Day 42 between MB-1 and placebo
Measured: Day 0 to 42
The difference in change in anthropometric measures (waist and hip circumference) between MB-1 and placebo
The difference in change in anthropometric measures (waist and hip circumference) from baseline at Days 42 between MB-1 and placebo
Measured: Day 0 to 42
The difference in change in anthropometric measures (waist and hip circumference) between MB-1 and placebo
The difference in change in anthropometric measures (waist and hip circumference) from baseline at Day 84 between MB-1 and placebo
Measured: 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)
The difference in change in body composition (fat and muscle mass) from baseline at Day 84 between MB-1 and placebo as assessed by Dual-Energy X-Ray Absorption (DEXA)
Measured: Day 0 to 84
The difference in change in fasting blood glucose between MB-1 and placebo as assessed by fasting blood glucose
The difference in change in fasting blood glucose from baseline at Day 84 between MB-1 and placebo as assessed by fasting blood glucose
Measured: Day 0 to 84
The difference in change in lipid profile between MB-1 and placebo
The difference in change in lipid profile: total cholesterol (TC) between MB-1 and placebo
Measured: Day 0 to 84
The difference in change in lipid profile between MB-1 and placebo
The difference in change in lipid profile: low-density lipoprotein cholesterol (LDL-C between MB-1 and placebo
Measured: Day 0 to 84
The difference in change in lipid profile between MB-1 and placebo
The difference in change in lipid profile: high-density lipoprotein cholesterol (HDL-C) between MB-1 and placebo
Measured: Day 0 to 84
The difference in change in lipid profile between MB-1 and placebo
The difference in change in lipid profile: non-HDL-C between MB-1 and placebo
Measured: Day 0 to 84
The difference in change in lipid profile between MB-1 and placebo
The difference in change in lipid profile: triglycerides (TG) between MB-1 and placebo
Measured: Day 0 to 84
The difference in change in lipid profile between MB-1 and placebo
The difference in change in lipid profile: TG/HDL-C, TC/HDL-C and LDL-C/HDL-C between MB-1 and placebo
Measured: 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.
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.
Measured: Day 0 to 84
The difference in change in ratings of energy between MB-1 and placebo as assessed by the weekly Energy Likert scale.
The difference in change in ratings of energy from baseline at Day 84 between MB-1 and placebo as assessed by the weekly Energy Likert scale.
Measured: Day 0 to 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start5 Aug 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arrae
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363148
- Sponsor's protocol ID
- 25ARCCM01
- Status last verified
- Sep 2026
- First submitted
- 15 Jan 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07363148
- Acronym / sponsor ID
- 25ARCCM01
- Conditions
- Obese, Overweight Adults, Obese Adults, Body Weight Control, BMI
- Keywords
- Arrae, MB-1, Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ArraeIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MB-1 | Experimental | Dietary Supplement: MB-1MB-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. |
| Placebo | Experimental | Other: PlaceboPlacebo contains white rice flour |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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:
- Stable body weight defined as a <5% change in body weight in the three months prior to baseline as assessed by the QI
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MB-1Participants 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. | Dietary supplement | MB-1 |
| PlaceboParticipants 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. | Other | Placebo |
Primary outcome
The difference in change in body weight between MB-1 and placebo
Time frame: Day 0 to 84
The difference in change in body weight from baseline at Day 84 between MB-1 and placebo
13 secondary outcomes
The difference in change in body weight between MB-1 and placebo
Time frame: Day 0 to 42
The difference in change in anthropometric measures (waist and hip circumference) between MB-1 and placebo
Time frame: Day 0 to 42
The difference in change in anthropometric measures (waist and hip circumference) between MB-1 and placebo
Time frame: 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)
Time frame: Day 0 to 84
The difference in change in fasting blood glucose between MB-1 and placebo as assessed by fasting blood glucose
Time frame: Day 0 to 84
The difference in change in lipid profile between MB-1 and placebo
Time frame: Day 0 to 84
The difference in change in lipid profile between MB-1 and placebo
Time frame: Day 0 to 84
The difference in change in lipid profile between MB-1 and placebo
Time frame: Day 0 to 84
The difference in change in lipid profile between MB-1 and placebo
Time frame: Day 0 to 84
The difference in change in lipid profile between MB-1 and placebo
Time frame: Day 0 to 84
The difference in change in lipid profile between MB-1 and placebo
Time frame: 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.
Time frame: Day 0 to 84
The difference in change in ratings of energy between MB-1 and placebo as assessed by the weekly Energy Likert scale.
Time frame: Day 0 to 84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MB-1 in people with Obese and Overweight Adults, run by Arrae at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Lewis, PhD (519-438-9374 x 248, elewis@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in change in body weight between MB-1 and placebo (time frame: Day 0 to 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.