HealthyNCT01066260
Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects
A study testing Probiotic formulation in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
Probiotic administration is associated with health benefits on gut barrier integrity and immunological functions of the gastrointestinal tract. Recently, probiotic consumption was proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al. 2009). Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Probiotic formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2009to Sep 2010
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Masss Index (BMI) 25 - 30 kg/m2
- Healthy (determined by medical questionnaire)
- Able to commit to the duration of the study
- Providing consent for participation
Who cannot join
- History of cardiovascular disease (CVD), diabetes, cancer, renal, thyroid or hepatic disease
- History of gastrointestinal surgery
- History of sleep disorders
- Recent bacterial infection (< 2 weeks)
- Weight loss > 5 kg in the last 3 months
- Under antibiotics or treatments (medical or nutritional program) affecting body weight, appetite, energy expenditure lipid-lowering, hypertension or inflammation or glucose control for the last 3 months or taking hormone replacement therapy
Show all 13Show fewer
- Excessive consumption of products enriched in probiotics (> 4 servings per week) within the last 4 weeks before the start of the study
- History of drug or alcohol abuse (> 2 drinks daily)
- Regular smokers (more than 5 cigarettes a day)
- Not eating breakfast regularly or eating breakfast before 6h00.
- Not willing to eat any of the foods to be served in the study for any reason
- Physical activity level > 150 min of moderate or intense exercise per week
- Concurrent or recent intervention study (within 60 days)
Trial locations and contacts
1 site in 1 country.
About this study
Probiotic administration is associated with health benefits on gut barrier integrity and immunological functions of the gastrointestinal tract. Recently, probiotic consumption was proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al. 2009). Changes in energy metabolism might be involved in the effects of probiotics on weight control.
The objective of this study was to assess the efficacy of the consumption of a probiotic formulation on energy balance in overweight subjects.
- Conditions
- Healthy
- Being tested
- Probiotic formulation, Placebo
- Keywords
- Probiotics, Energy balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic formulationDietary supplement
Twice a day for 24 days
PlaceboOther
Twice a day for 24 days
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Not described Receives: Dietary Supplement: Probiotic formulation |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake
Measured: Lunch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionMay 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maurice Beaumont, MD, Principal investigator, Société des Produits Nestlé (SPN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066260
- Sponsor's protocol ID
- 09-24 MET
- Status last verified
- Jun 2013
- First submitted
- 9 Feb 2010
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects
- ClinicalTrials.gov ID
- NCT01066260
- Acronym / sponsor ID
- 09-24 MET
- Conditions
- Healthy
- Keywords
- Probiotics, Energy balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 10 Feb 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.
Probiotic administration is associated with health benefits on gut barrier integrity and immunological functions of the gastrointestinal tract. Recently, probiotic consumption was proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al. 2009). Changes in energy metabolism might be involved in the effects of probiotics on weight control.
The objective of this study was to assess the efficacy of the consumption of a probiotic formulation on energy balance in overweight subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic formulation |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body Masss Index (BMI) 25 - 30 kg/m2
- Healthy (determined by medical questionnaire)
- Able to commit to the duration of the study
- Providing consent for participation
Key exclusion criteria (13 listed)
- History of cardiovascular disease (CVD), diabetes, cancer, renal, thyroid or hepatic disease
- History of gastrointestinal surgery
- History of sleep disorders
- Recent bacterial infection (< 2 weeks)
- Weight loss > 5 kg in the last 3 months
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 |
|---|---|---|
| Probiotic formulationTwice a day for 24 days | Dietary supplement | Probiotic |
| PlaceboTwice a day for 24 days | Other | Placebo |
Primary outcome
Energy intake
Time frame: Lunch
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 4 Jun 2013.
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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.
Maurice Beaumont, MD principal investigator
Société des Produits Nestlé (SPN)
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 formulation in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 4 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: finished, as of the sponsor's last update on 4 Jun 2013. 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 Switzerland. 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?
Energy intake (time frame: Lunch). 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 4 Jun 2013.