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Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects

This study has been completed.
Information provided by (Responsible Party):
Nestlé Identifier:
First received: February 9, 2010
Last updated: June 3, 2013
Last verified: June 2013

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 Intervention
Healthy Dietary Supplement: Probiotic formulation Other: Placebo

Study Type: Interventional
Study Design: 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

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Energy intake [ Time Frame: Lunch ]

Enrollment: 80
Study Start Date: October 2009
Study Completion Date: September 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic Dietary Supplement: Probiotic formulation
Twice a day for 24 days
Placebo Comparator: Placebo Other: Placebo
Twice a day for 24 days


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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01066260

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

Responsible Party: Nestlé Identifier: NCT01066260     History of Changes
Other Study ID Numbers: 09-24 MET
Study First Received: February 9, 2010
Last Updated: June 3, 2013

Keywords provided by Nestlé:
Energy balance

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms processed this record on August 22, 2017