Obesity, Metabolically BenignPhase 1NCT04507971
Effects of MET-3 and MET-5 on Gut Microbiome and Metabolic Function in Men and Women With Hypertriglyceridemia
A Phase 1 study testing MET-3 in people with Obesity, Metabolically Benign, run by NuBiyota at 1 site in Canada.
Trial summary
The purpose of this pilot study is to determine the effects of two human microbiome formulations (MET-3 and MET-5) on fasting serum TG concentration. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Obesity, Metabolically Benign
- What is being tested?
- MET-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jun 2020to 31 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or non-pregnant, non-lactating females who are taking adequate contraceptive precaution, aged 18 to 49 years inclusive;
- Body Mass Index (BMI) ≥25.0 kg/m2 and ≤40.0 kg/m2;
- Stable body weight (±4 kg) for the past 4 months with no intention to gain or lose weight;
- Fasting serum triglycerides ≥1.5 mmol/L (133 mg/dL) and <8 mmol/L (<709 mg/dL) at screening;
- Fasting serum glucose <7.0 mmol/L (<126 mg/dl);
- HbA1c <6.5% at screening;
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- Blood pressure <160/100;
- AST, ALT and ALP ≤3 times the upper limit of normal (liver function) at screening;
- Serum creatinine < 1.5 times the upper limit of normal (kidney function) at screening;
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial;
- Willing to refrain from taking probiotic supplements throughout the trial;
- Willing to abstain from strenuous exercise, consuming alcoholic drinks 24 hours before study days and during study days;
- Willing to maintain current dietary supplement and medication use throughout the trial. On test days, subject agrees to bring any dietary supplements or medications taken in the morning with them to the clinical site to take just prior to the glucose test meal;
- Subject is not currently participating nor recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement or lifestyle modification;
- Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator and other authorized agents as indicated in the consent form.
Who cannot join
- Failure to meet any one of the inclusion criteria.
- Smokers
- Known history of AIDS, hepatitis, a history or presence of clinically important endocrine conditions (including Type 1 or Type 2 diabetes mellitus), pulmonary, biliary or gastrointestinal (GI) disorders or new onset cardiovascular disease within 6 months of screening (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke).
- Use of antibiotics within 1 week of screening.
- Use of probiotic supplements within 1 week of screening.
- Use of medications known to influence carbohydrate metabolism, GI function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or with any condition which might, in the opinion of the Investigator, either: a) make participation dangerous to the subject or to others, b) affect the results, or c) influence the ability of the subject to comply with study procedures.
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- Major trauma or surgical event within 3 months of screening.
- Unwillingness or inability to comply with the experimental procedures and to follow study safety guidelines.
- Known intolerance, sensitivity or allergy to any ingredients in the investigational agent.
- Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
- History of cancer in the prior two years, except for non-melanoma skin cancer.
- Recent history (within 12 months of screening) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as > 14 drinks per week (1 drink=12 oz beer, 5 oz wine, or 1.5 oz distilled spirits).
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Inquis Clinical Research
Toronto, Ontario, M5C2N8
Catherine Braunstein, MSc, 416 861-0506 ext. 206, cbraunstein@inquis.com
Thomas Wolever, MD/PhD, 416 861-0506 ext. 210, twolever@inquis.com
About this study
The purpose of this pilot study is to determine the effects of two human microbiome formulations (MET-3 and MET-5) on fasting serum TG concentration.
Read the detailed description
Obesity is a condition characterized by an excess amount of body fat, and is defined as a body mass index (BMI) of 30 kg/m² or greater. The rising prevalence of obesity in all parts of the world is of great public health concern due to the fact that obesity is associated with many causes of morbidity and mortality. Excess body fat accumulates when energy intake is greater than energy expenditure and recently, the role of the colonic microbiome has been highlighted as a potential contributor to energy balance. The obese microbiome is suggested to promote obesity due to an excess production of short-chain fatty acids, and, thus, increased colonic energy availability.
The purpose of this pilot study is to determine the effects of two human microbiome formulations (MET-3 and MET-5) on fasting serum TG concentration.
- Conditions
- Obesity, Metabolically Benign
- Being tested
- MET-3
- Medical subject headings
- Obesity, Metabolically Benign
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MET-3Biological
Also called MET-5
Human microbiome supplementation derived from bacterial strains isolated from fecal matter and grown in a laboratory environment
| Study group | Role | What they receive |
|---|---|---|
| MET-3 2.5 g daily for 4 weeks | Experimental | MET-3 is composed of twenty-two strains of bacteria and was designed to treat metabolic syndrome. The strains that were selected are based on strains that are known butyrate producers, associated with healthy subjects and improved gut barrier function. MET-3 is provided in capsule form and 5 capsules will be swallowed by each subject once daily for 4 weeks. Receives: Biological: MET-3 |
| MET-5 2.5 g daily for 4 weeks | Experimental | MET-5 is a new product composed of twenty-six strains of bacteria isolated from the stool of a different healthy donor than MET-3. Although it is expected to work in a similar fashion to MET-3, it contains some strains that are unique in comparison to the original MET-3 formulation and have been associated with leanness in the scientific literature. MET-5 is provided in capsule form and 5 capsules will be swallowed by each subject once daily for 4 weeks. Receives: Biological: MET-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood lipid levels
triglycerides, HDL and LDL cholesterol
Measured: Baseline vs. Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start22 Jun 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, Metabolically BenignStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two parallel treatment arms. Responders to either treatment will continue with their assigned treatment through to the end of the study. Non-responders will cross-over to the other treatment at week 4 of the study.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuBiyota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Wolever, MD/PhD, Principal investigator, INQUIS Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507971
- Sponsor's protocol ID
- MET-5 101
- Status last verified
- Aug 2020
- First submitted
- 7 Aug 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of MET-3 and MET-5 on Gut Microbiome and Metabolic Function in Men and Women With Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT04507971
- Acronym / sponsor ID
- MET-5 101
- Conditions
- Obesity, Metabolically Benign
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NuBiyotaUniversity, hospital or other
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Aug 2020 (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 purpose of this pilot study is to determine the effects of two human microbiome formulations (MET-3 and MET-5) on fasting serum TG concentration.
Detailed description
Obesity is a condition characterized by an excess amount of body fat, and is defined as a body mass index (BMI) of 30 kg/m² or greater. The rising prevalence of obesity in all parts of the world is of great public health concern due to the fact that obesity is associated with many causes of morbidity and mortality. Excess body fat accumulates when energy intake is greater than energy expenditure and recently, the role of the colonic microbiome has been highlighted as a potential contributor to energy balance. The obese microbiome is suggested to promote obesity due to an excess production of short-chain fatty acids, and, thus, increased colonic energy availability.
The purpose of this pilot study is to determine the effects of two human microbiome formulations (MET-3 and MET-5) on fasting serum TG concentration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two parallel treatment arms. Responders to either treatment will continue with their assigned treatment through to the end of the study. Non-responders will cross-over to the other treatment at week 4 of the study.
| Arm | Type | Receives |
|---|---|---|
| MET-3 2.5 g daily for 4 weeks | Experimental | Biological: MET-3MET-3 is composed of twenty-two strains of bacteria and was designed to treat metabolic syndrome. The strains that were selected are based on strains that are known butyrate producers, associated with healthy subjects and improved gut barrier function. MET-3 is provided in capsule form and 5 capsules will be swallowed by each subject once daily for 4 weeks. |
| MET-5 2.5 g daily for 4 weeks | Experimental | Biological: MET-3MET-5 is a new product composed of twenty-six strains of bacteria isolated from the stool of a different healthy donor than MET-3. Although it is expected to work in a similar fashion to MET-3, it contains some strains that are unique in comparison to the original MET-3 formulation and have been associated with leanness in the scientific literature. MET-5 is provided in capsule form and 5 capsules will be swallowed by each subject once daily for 4 weeks. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Male or non-pregnant, non-lactating females who are taking adequate contraceptive precaution, aged 18 to 49 years inclusive;
- Body Mass Index (BMI) ≥25.0 kg/m2 and ≤40.0 kg/m2;
- Stable body weight (±4 kg) for the past 4 months with no intention to gain or lose weight;
- Fasting serum triglycerides ≥1.5 mmol/L (133 mg/dL) and <8 mmol/L (<709 mg/dL) at screening;
- Fasting serum glucose <7.0 mmol/L (<126 mg/dl);
Key exclusion criteria (13 listed)
- Failure to meet any one of the inclusion criteria.
- Smokers
- Known history of AIDS, hepatitis, a history or presence of clinically important endocrine conditions (including Type 1 or Type 2 diabetes mellitus), pulmonary, biliary or gastrointestinal (GI) disorders or new onset cardiovascular disease within 6 months of screening (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke).
- Use of antibiotics within 1 week of screening.
- Use of probiotic supplements within 1 week of screening.
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 |
|---|---|---|
| MET-3Also: MET-5Human microbiome supplementation derived from bacterial strains isolated from fecal matter and grown in a laboratory environment | Biological | MET-3 2.5 g daily for 4 weeks, MET-5 2.5 g daily for 4 weeks |
Primary outcome
Fasting blood lipid levels
Time frame: Baseline vs. Week 7
triglycerides, HDL and LDL cholesterol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Thomas Wolever, MD/PhD principal investigator
INQUIS Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MET-3 in people with Obesity, Metabolically Benign, run by NuBiyota 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 15 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 11 Aug 2020. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Braunstein, MSc (416.861.0506 ext. 206, cbraunstein@inquis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood lipid levels (time frame: Baseline vs. Week 7). 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 11 Aug 2020; AzTrials last refreshed its copy on 7 Nov 2026.