Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01066260
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : June 4, 2013
Information provided by (Responsible Party):

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Probiotic formulation Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects
Study Start Date : October 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : September 2010

Arm Intervention/treatment
Experimental: Probiotic Dietary Supplement: Probiotic formulation
Twice a day for 24 days

Placebo Comparator: Placebo Other: Placebo
Twice a day for 24 days

Primary Outcome Measures :
  1. Energy intake [ Time Frame: Lunch ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01066260

Nestlé Research Center
Lausanne, Vaud, Switzerland, 1000
Sponsors and Collaborators
Principal Investigator: Maurice Beaumont, MD Nestlé

Responsible Party: Nestlé Identifier: NCT01066260     History of Changes
Other Study ID Numbers: 09-24 MET
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: June 2013

Keywords provided by Nestlé:
Energy balance

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms