Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects

NCT01066260 | Completed DMC

• 1 other identifier: 09-24 MET
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Probiotics; Energy balance

Outcome Measures

Primary Outcomes (1)

• Energy intake

  Lunch

Study Arms (2)

Probiotic

EXPERIMENTAL

Dietary Supplement: Probiotic formulation

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Probiotic formulation DIETARY_SUPPLEMENT

Twice a day for 24 days

Probiotic

Placebo OTHER

Twice a day for 24 days

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Nestlé Research Center

Lausanne, Canton of Vaud, 1000, Switzerland

Location

Study Officials

• Maurice Beaumont, MD

  Société des Produits Nestlé (SPN)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 10, 2010
• Study Start: October 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

CH (1)