ObesityNCT02893943
Impact of Probiotics on Weight Control and Body Composition in Overweight and Obese Individuals
A study testing Probiotics in people with Obesity, run by University of Manitoba at 1 site in Canada.
Trial summary
The aim of the study is to evaluate the potential of probiotics on weight management. It is hypothesized that the consumption of 1 capsule of probiotics daily will modulate the intestinal gut microbiota thereby reducing body weight and fat compared to those who do not consume probiotics. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2017to 31 Jan 2018
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight, obese men and women volunteers aged between 18-65 yrs
- BMI equal to or greater than 25
- Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits.
- Willingness to discontinue consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements), laxatives, prebiotics and any substances for control body weight.
- Able to provide informed consent.
- Women of childbearing potential with a negative pregnancy test at screening.
Who cannot join
- BMI greater than 35
- Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease.
- Those currently taking (or have taken within the last 3 months) cholesterol-lowering, triglyceride-lowering or hypertension medications.
- Those currently taking (or have taken within the last 3 months) lipid-lowering supplements, (e.g., omega-3 supplements, plant sterols/stanols foods and/or supplements, fibre, etc).
- Smokers.
- Allergic to milk, soy, or yeast (some of our probiotics strains may contains these items).
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- Use of another investigational product within 3 months of the screening visit.
- Positive pregnancy test in women of child-bearing potential.
- Known to be pregnant or breast-feeding or planning on becoming pregnant in the next 18 months.
- Women of child-bearing potential not using effective contraception.
- Use of any other treatments (medication or nutritional program) affecting body weight, food intake and/or energy expenditure.
- Menopausal women.
- Weight gain or loss of at least 10lbs in previous three months.
- Uncontrolled angina within the past six months.
- Cancer treatment (radiation, chemotherapy, surgery) within past six months or any other treatment or condition known to weaken the immune system (such as systemic corticosteroids or HIV/AIDS).
- Any physical condition deemed likely to significantly interfere with individuals' ability to participate in a nutritional intervention.
- Currently or at any point during the study participating in Weight Watcher's or another weight loss program or taking a medication for weight loss.
- History of drug or alcohol (> 2 drinks daily) abuse.
- Abnormal thyroid hormone levels.
- Immune-compromised conditions.
- Participant experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain (past week and chronic).
- Participants exercising > 15 miles/wk or 4,000 kcal/wk.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 2N2
About this study
The aim of the study is to evaluate the potential of probiotics on weight management. It is hypothesized that the consumption of 1 capsule of probiotics daily will modulate the intestinal gut microbiota thereby reducing body weight and fat compared to those who do not consume probiotics. In addition, a diet supplemented with probiotics can be expected to be more beneficial than a diet without probiotic supplementation in impacting biomarkers of obesity-associated disorders including diabetes, hypertension and cardiovascular disease (CVD).
Read the detailed description
Overweight, obese men and women volunteers aged between 18-65 yrs with BMI greater than or equal to 25 will be recruited from the Winnipeg (Manitoba, Canada) area to participate in a two arm crossover, randomized, double-blind, placebo-controlled, free-living intervention study for 60 days per study period following obtainment of informed consent. Participants will be informed to maintain their usual diets as well as their physical activity level.
After obtaining consent, participants will be randomized to receive either 1 capsule containing probiotics, or 1 capsule of placebo daily for 60 days. Compared with the probiotic capsules, the placebo contains the same carrier material and is similar in size, shape and taste.
- Conditions
- Obesity
- Being tested
- Probiotics, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Active comparator | 1 capsule per day containing probiotics Receives: Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | 1 capsule per day without probiotics Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: 60 days
Secondary outcomes (16)
Body mass index
Measured: 60 days
Body fat percentage
Measured: 60 days
Waist circumference
Measured: 60 days
Hip circumference
Measured: 60 days
Total fat mass
Measured: 60 days
Total lean mass
Measured: 60 days
Gut microbiome
Stool samples will be collected from participants to analyze intestinal microbiota community composition
Measured: 60 days
Blood pressure
Measured: 60 days
Blood total cholesterol
Measured: 60 days
Blood low-density lipoprotein cholesterol
Measured: 60 days
Blood high-density lipoprotein cholesterol
Measured: 60 days
Blood triglycerides
Measured: 60 days
Blood glucose
Measured: 60 days
Blood insulin
Measured: 60 days
Aspartate aminotransferase
Measured: 60 days
Alanine transaminase
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start1 Jan 2017
- Primary completion31 Jul 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Lallemand Health Solutions
- Responsible party
- Sponsor
- Investigators
- Rotimi Aluko, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893943
- Sponsor's protocol ID
- B2016:033
- Status last verified
- Apr 2021
- First submitted
- 29 Aug 2016
- Last updated
- 17 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Probiotics on Weight Control and Body Composition in Overweight and Obese Individuals
- ClinicalTrials.gov ID
- NCT02893943
- Acronym / sponsor ID
- B2016:033
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Lallemand Health Solutions
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 9 Sep 2016 (estimated)
- 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 aim of the study is to evaluate the potential of probiotics on weight management. It is hypothesized that the consumption of 1 capsule of probiotics daily will modulate the intestinal gut microbiota thereby reducing body weight and fat compared to those who do not consume probiotics. In addition, a diet supplemented with probiotics can be expected to be more beneficial than a diet without probiotic supplementation in impacting biomarkers of obesity-associated disorders including diabetes, hypertension and cardiovascular disease (CVD).
Detailed description
Overweight, obese men and women volunteers aged between 18-65 yrs with BMI greater than or equal to 25 will be recruited from the Winnipeg (Manitoba, Canada) area to participate in a two arm crossover, randomized, double-blind, placebo-controlled, free-living intervention study for 60 days per study period following obtainment of informed consent. Participants will be informed to maintain their usual diets as well as their physical activity level.
After obtaining consent, participants will be randomized to receive either 1 capsule containing probiotics, or 1 capsule of placebo daily for 60 days. Compared with the probiotic capsules, the placebo contains the same carrier material and is similar in size, shape and taste.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Active comparator | Dietary Supplement: Probiotics1 capsule per day containing probiotics |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 capsule per day without probiotics |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Overweight, obese men and women volunteers aged between 18-65 yrs
- BMI equal to or greater than 25
- Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits.
- Willingness to discontinue consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements), laxatives, prebiotics and any substances for control body weight.
- Able to provide informed consent.
Key exclusion criteria (22 listed)
- BMI greater than 35
- Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease.
- Those currently taking (or have taken within the last 3 months) cholesterol-lowering, triglyceride-lowering or hypertension medications.
- Those currently taking (or have taken within the last 3 months) lipid-lowering supplements, (e.g., omega-3 supplements, plant sterols/stanols foods and/or supplements, fibre, etc).
- Smokers.
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 |
|---|---|---|
| Probiotics | Dietary supplement | Probiotics |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Body weight
Time frame: 60 days
16 secondary outcomes
Body mass index
Time frame: 60 days
Body fat percentage
Time frame: 60 days
Waist circumference
Time frame: 60 days
Hip circumference
Time frame: 60 days
Total fat mass
Time frame: 60 days
Total lean mass
Time frame: 60 days
Gut microbiome
Time frame: 60 days
Blood pressure
Time frame: 60 days
Blood total cholesterol
Time frame: 60 days
Blood low-density lipoprotein cholesterol
Time frame: 60 days
Blood high-density lipoprotein cholesterol
Time frame: 60 days
Blood triglycerides
Time frame: 60 days
Blood glucose
Time frame: 60 days
Blood insulin
Time frame: 60 days
Aspartate aminotransferase
Time frame: 60 days
Alanine transaminase
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
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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.
Rotimi Aluko, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Obesity, run by University of Manitoba 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 6 inclusion and 22 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: finished, as of the sponsor's last update on 17 Mar 2023. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 60 days). 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 17 Mar 2023.