Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects

Nestlé

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Probiotic formulation; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01066260

09-24 MET

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Treatment:

Dietary Supplement: Probiotic formulation

Placebo

Placebo Comparator group

Treatment:

Other: Placebo