ObesityNCT01106924
Effects of a Probiotic on Body Weight
A study testing Probiotic in people with Obesity, run by Laval University at 1 site in Canada.
Trial summary
Probiotics administration is associated with health benefits on gut barrier integrity and immunological functions of the gastrointestinal tract. Recently, probiotics consumption was proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al. 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?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to May 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: between 18 and 55 years old
- Weight: 30.0 kg/m2 ≤ BMI ≤ 39.9 kg/m2
- Non smokers
- Good general health
- A 2 weeks probiotics washout period prior to treatment initiation
Who cannot join
- Under antibiotics or treatments (medication or nutritional program) affecting body weight or glucose control for the last 3 months
- Currently participating or having participated in another clinical trial during the last 6 months prior to the beginning of this study
- Pregnant women, women who have given birth in the past year, women planning pregnancy in the next 6 months or menopausal women
- Excessive consumption of products enriched in probiotics (> 4 servings per week).
- History of drug or alcohol (> 2 drinks daily) abuse
- Abnormal thyroid hormone levels
Show all 24Show fewer
- Intake of medication that could affect body weight and/or energy expenditure
- Family history of type 2 diabetes in first degree relatives
- Allergy to the ingredients in the study product and placebo
- Participant with anaemia
- Participant with a recent history of large weight fluctuations (e.g., > 10 kg in the past year
- Immune-compromised conditions
- Participant experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain
- Participant with co-morbidity associated with obesity:
- Hypertension (≥ 140/90 mm Hg)
- Current use of antihypertensive medications, depression
- Prediabetes (fasting glucose >100mg/dL)
- Family history of premature coronary artery disease
- LDL > 2.0 mmol/L
- HDL < 1.3 mmol/L
- Smoking
- Obstructive sleep apnea
- Type 2 diabetes
- Cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Consumption of a Probiotic Formulation on Weight Control in Obese Subjects
Probiotics administration is associated with health benefits on gut barrier integrity and immunological functions of the gastrointestinal tract. Recently, probiotics consumption was proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al. 2009) as well as abdominal fat in human (Kadooka Y, 2010). The mechanisms explaining the effects of probiotics in weight control are not well understood.
The primary objective of the clinical trial is to investigate whether a consumption of a probiotic formula when compared to an intake of a placebo, is associated with a greater reduction of body weight.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticOther
daily probiotic consumption
PlaceboOther
daily placebo consumption
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | daily probiotic consumption Receives: Other: Probiotic |
| Placebo | Placebo comparator | daily placebo consumption Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight; Body composition (DEXA); Waist circumference
Measured: PRE and POST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2012
- Study completionMay 2012
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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106924
- Sponsor's protocol ID
- 08.22 NRC
- Status last verified
- Sep 2011
- First submitted
- 19 Apr 2010
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Consumption of a Probiotic Formulation on Weight Control in Obese Subjects
- ClinicalTrials.gov ID
- NCT01106924
- Acronym / sponsor ID
- 08.22 NRC
- Conditions
- Obesity
- Keywords
- Probiotics, Weight control, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Study start
- Jan 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 20 Apr 2010 (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.
Probiotics administration is associated with health benefits on gut barrier integrity and immunological functions of the gastrointestinal tract. Recently, probiotics consumption was proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al. 2009) as well as abdominal fat in human (Kadooka Y, 2010). The mechanisms explaining the effects of probiotics in weight control are not well understood.
The primary objective of the clinical trial is to investigate whether a consumption of a probiotic formula when compared to an intake of a placebo, is associated with a greater reduction of body weight.
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: Probioticdaily probiotic consumption |
| Placebo | Placebo comparator | Other: Placebodaily placebo consumption |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: between 18 and 55 years old
- Weight: 30.0 kg/m2 ≤ BMI ≤ 39.9 kg/m2
- Non smokers
- Good general health
- A 2 weeks probiotics washout period prior to treatment initiation
Key exclusion criteria (24 listed)
- Under antibiotics or treatments (medication or nutritional program) affecting body weight or glucose control for the last 3 months
- Currently participating or having participated in another clinical trial during the last 6 months prior to the beginning of this study
- Pregnant women, women who have given birth in the past year, women planning pregnancy in the next 6 months or menopausal women
- Excessive consumption of products enriched in probiotics (> 4 servings per week).
- History of drug or alcohol (> 2 drinks daily) abuse
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 |
|---|---|---|
| Probioticdaily probiotic consumption | Other | Probiotic |
| Placebodaily placebo consumption | Other | Placebo |
Primary outcome
Body weight; Body composition (DEXA); Waist circumference
Time frame: PRE and POST
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 28 May 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic 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 5 inclusion and 24 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 28 May 2012. 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; Body composition (DEXA); Waist circumference (time frame: PRE and POST). 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 28 May 2012.