ObesityPhase 2NCT02962583
The Addition of Probiotic Consumption to a Nutritional Intervention and Caloric Restriction on Body Weight and Composition in Overweight Participants
A Phase 2 study testing Weight loss and Probiotic Formula in people with Obesity, run by Laval University at 1 site in Canada.
Trial summary
Limited interventional human studies suggest that probiotic supplementation may be a beneficial strategy for promoting weight loss when added to a nutritional intervention via their effects on lipid absorption and metabolic signaling molecules. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Weight loss and Probiotic Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to 6 Jun 2019
- Phase
- Phase 2
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 55 years
- BMI between 27.0 and 39.9 kg/m2
- Sedentary to moderate active (less than 30 minutes of physical activity, 3 times per week)
- Willingness to complete questionnaires, records, and diaries associated with the study and to complete all study visits
- Willingness to discontinue consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements), laxatives, prebiotics and any substance for body weight control
- Willingness and ability to provide informed consent in French
- Willingness to receive random assignment to probiotic or placebo supplementation
- Committed to losing weight over the 12-week study period
Who cannot join
- Smokers
- Use of another investigational product within three months of the pre-baseline period.
- 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 which include:
- Hormonal contraceptives including combined oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormonal implants
- Intrauterine devices (IUD) or Intrauterine system (IUS)
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- Tubal ligation
- Vasectomy of partner
- Double barrier method (use of physical barrier by both partners, e.g. male condom and diaphragm, male condom and cervical cap)
- Positive pregnancy test in women of child-bearing potential
- Menopausal women
- Allergic to milk, soy, or yeast
- Weight gain or loss of at least 10 lbs in previous three months
- Inflammatory bowel syndrome, celiac disease, short bowel syndrome, or any other malabsorptive syndrome
- Uncontrolled angina within the past six months
- Insulin-dependent diabetes (oral medications are not exclusionary)
- Serious and/or unstable medical conditions (e.g. cardiovascular, renal, lung, psychiatric illness, bleeding disorders, etc.)
- 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 HIVIAIDS).
- 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.
- Under antibiotics or treatments (medication or nutritional program) affecting body weight Intake and/or energy expenditure
- History of drug or alcohol (> 9 drinks weekly) abuse
- Abnormal thyroid hormone levels
- Immune-compromised conditions
- Participant experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Addition of Probiotic Consumption to a Nutritional Intervention and Caloric Restriction on Body Weight and Composition in Overweight Participants: A Randomized, Double-blind, Placebo Controlled Study
Limited interventional human studies suggest that probiotic supplementation may be a beneficial strategy for promoting weight loss when added to a nutritional intervention via their effects on lipid absorption and metabolic signaling molecules. The purpose of this study is to evaluate the effects of addition of a probiotic supplementation to a weight loss intervention on body weight, body composition and overall health in overweight adults.
- Conditions
- Obesity
- Being tested
- Weight loss, Probiotic Formula, Placebos
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight lossOther
Probiotic FormulaDrug
PlacebosDrug
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Daily probiotic consumption Receives: Other: Weight loss; Drug: Probiotic Formula |
| Placebo | Placebo comparator | Daily placebo consumption Receives: Other: Weight loss; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline body weight at 12 weeks
Measured: 12 weeks
Secondary outcomes (13)
Change from Baseline BMI at 12 weeks
Measured: 12 weeks
Change from Baseline waist circumference data at 12 weeks
Measured: 12 weeks
Change from Baseline sagittal abdominal diameter data at 12 weeks
Measured: 12 weeks
Change from Baseline body composition at 12 weeks
DXA
Measured: 12 weeks
Change from Baseline stress level at 12 weeks
Questionnaire
Measured: 12 weeks
Change from Baseline anxiety level at 12 weeks
Questionnaire
Measured: 12 weeks
Change from Baseline depression symptoms at 12 weeks
Questionnaire
Measured: 12 weeks
Change from Baseline sleeping habits at 12 weeks
Questionnaire
Measured: 12 weeks
Change from Baseline intestinal microbiota composition at 12 weeks
Changes in the concentrations of the probiotic strains in the stools will be measured with strain specific DNA in fecal samples.
Measured: 12 weeks
Change from Baseline C-reactive protein at 12 weeks
Measured: 12 weeks
Change from Baseline TNF-a at 12 weeks
Measured: 12 weeks
Change from Baseline interleukin-6 at 12 weeks
Measured: 12 weeks
Change from Baseline lipopolysaccharide (LPS) at 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startJan 2017
- Primary completion6 Jun 2019
- Study completion6 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Lallemand Health Solutions
- Responsible party
- Principal investigator, Angelo Tremblay, Laval University
- Investigators
- Angelo Tremblay, Ph.D, Study director, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962583
- Sponsor's protocol ID
- CLIN-21-012
- Status last verified
- Aug 2020
- First submitted
- 2 Nov 2016
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Choi BS, Brunelle L, Pilon G, Cautela BG, Tompkins TA, Drapeau V, Marette A, Tremblay A. Lacticaseibacillus rhamnosus HA-114 improves eating behaviors and mood-related factors in adults with overweight during weight loss: a randomized controlled trial. Nutr Neurosci. 2023 Jul;26(7):667-679. doi: 10.1080/1028415X.2022.2081288. Epub 2022 Jun 17.
PubMed 35714163
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Addition of Probiotic Consumption to a Nutritional Intervention and Caloric Restriction on Body Weight and Composition in Overweight Participants: A Randomized, Double-blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT02962583
- Acronym / sponsor ID
- CLIN-21-012
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Lallemand Health Solutions
- Study start
- Jan 2017
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 11 Nov 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.
Limited interventional human studies suggest that probiotic supplementation may be a beneficial strategy for promoting weight loss when added to a nutritional intervention via their effects on lipid absorption and metabolic signaling molecules. The purpose of this study is to evaluate the effects of addition of a probiotic supplementation to a weight loss intervention on body weight, body composition and overall health in overweight adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Other: Weight loss, Drug: Probiotic FormulaDaily probiotic consumption |
| Placebo | Placebo comparator | Other: Weight loss, Drug: PlacebosDaily placebo consumption |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Aged 18 to 55 years
- BMI between 27.0 and 39.9 kg/m2
- Sedentary to moderate active (less than 30 minutes of physical activity, 3 times per week)
- Willingness to complete questionnaires, records, and diaries associated with the study and to complete all study visits
- Willingness to discontinue consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements), laxatives, prebiotics and any substance for body weight control
Key exclusion criteria (25 listed)
- Smokers
- Use of another investigational product within three months of the pre-baseline period.
- Known to be pregnant or breast-feeding or planning on becoming pregnant in the next 18 months.
- Positive pregnancy test in women of child-bearing potential
- Menopausal women
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 |
|---|---|---|
| Weight loss | Other | Placebo, Probiotic |
| Probiotic Formula | Drug | Probiotic |
| Placebos | Drug | Placebo |
Primary outcome
Change from Baseline body weight at 12 weeks
Time frame: 12 weeks
13 secondary outcomes
Change from Baseline BMI at 12 weeks
Time frame: 12 weeks
Change from Baseline waist circumference data at 12 weeks
Time frame: 12 weeks
Change from Baseline sagittal abdominal diameter data at 12 weeks
Time frame: 12 weeks
Change from Baseline body composition at 12 weeks
Time frame: 12 weeks
Change from Baseline stress level at 12 weeks
Time frame: 12 weeks
Change from Baseline anxiety level at 12 weeks
Time frame: 12 weeks
Change from Baseline depression symptoms at 12 weeks
Time frame: 12 weeks
Change from Baseline sleeping habits at 12 weeks
Time frame: 12 weeks
Change from Baseline intestinal microbiota composition at 12 weeks
Time frame: 12 weeks
Change from Baseline C-reactive protein at 12 weeks
Time frame: 12 weeks
Change from Baseline TNF-a at 12 weeks
Time frame: 12 weeks
Change from Baseline interleukin-6 at 12 weeks
Time frame: 12 weeks
Change from Baseline lipopolysaccharide (LPS) at 12 weeks
Time frame: 12 weeks
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 2 Sep 2020.
- Derived from this study: PubMed 35714163Choi BS, Brunelle L, Pilon G, Cautela BG, Tompkins TA, Drapeau V, Marette A, Tremblay A. Lacticaseibacillus rhamnosus HA-114 improves eating behaviors and mood-related factors in adults with overweight during weight loss: a randomized controlled trial. Nutr Neurosci. 2023 Jul;26(7):667-679. doi: 10.1080/1028415X.2022.2081288. Epub 2022 Jun 17.
- 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.
Angelo Tremblay, Ph.D study director
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Weight loss and Probiotic Formula in people with Obesity, run by Laval University 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 8 inclusion and 25 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 2 Sep 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from Baseline body weight at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02962583, which also lists 1 linked publication.
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 2 Sep 2020.