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Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01066260
First received: February 9, 2010
Last updated: July 27, 2012
Last verified: February 2010
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066260

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

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01066260     History of Changes
Other Study ID Numbers: 09-24 MET
Study First Received: February 9, 2010
Last Updated: July 27, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Nestlé:
Probiotics
Energy balance

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013