Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Probiotic formulation; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1000
      • Nestlé Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Twice a day for 24 days
Experimental: Probiotic	Dietary supplement: Probiotic formulation; Twice a day for 24 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Energy intake	Lunch

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Maurice Beaumont, MD, Nestle

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: February 9, 2010
• First Submitted That Met QC Criteria: February 9, 2010
• First Posted (Estimate): February 10, 2010

Study Record Updates

• Last Update Posted (Estimate): June 4, 2013
• Last Update Submitted That Met QC Criteria: June 3, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Probiotics; Energy balance
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 09-24 MET