Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects

Healthy Clinical Trial

Official title:

Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066260
• Other study ID #: 09-24 MET
• Status: Completed
• Phase: N/A
• First received: February 9, 2010
• Last updated: June 3, 2013
• Start date: October 2009
• Est. completion date: September 2010

Study information

• Verified date: June 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Probiotic formulation
Twice a day for 24 days

Other:
• Placebo
Twice a day for 24 days

Locations

Country	Name	City	State
Switzerland	Nestlé Research Center	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy intake		Lunch	No