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Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Probiotic formulation
Placebo
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring Probiotics, Energy balance

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Nestlé Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Energy intake

Secondary Outcome Measures

Full Information

First Posted
February 9, 2010
Last Updated
June 3, 2013
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT01066260
Brief Title
Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects
Official Title
Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Probiotics, Energy balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic formulation
Intervention Description
Twice a day for 24 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Twice a day for 24 days
Primary Outcome Measure Information:
Title
Energy intake
Time Frame
Lunch

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurice Beaumont, MD
Organizational Affiliation
Société des Produits Nestlé (SPN)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nestlé Research Center
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1000
Country
Switzerland

12. IPD Sharing Statement

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Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects

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