Effects of a Probiotic on Body Weight

Study Overview
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Brief Summary
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Probiotics administration is associated with health benefits on gut barrier integrity and immunological functions of the gastrointestinal tract. Recently, probiotics consumption was proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al. 2009) as well as abdominal fat in human (Kadooka Y, 2010). The mechanisms explaining the effects of probiotics in weight control are not well understood. The primary objective of the clinical trial is to investigate whether a consumption of a probiotic formula when compared to an intake of a placebo, is associated with a greater reduction of body weight.

Official Title
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Effects of Consumption of a Probiotic Formulation on Weight Control in Obese Subjects

Conditions
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Obesity

Intervention / Treatment
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* Other: Probiotic
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: between 18 and 55 years old Weight: 30.0 kg/m2 ≤ BMI ≤ 39.9 kg/m2 Non smokers Good general health A 2 weeks probiotics washout period prior to treatment initiation Exclusion Criteria: Under antibiotics or treatments (medication or nutritional program) affecting body weight or glucose control for the last 3 months Currently participating or having participated in another clinical trial during the last 6 months prior to the beginning of this study Pregnant women, women who have given birth in the past year, women planning pregnancy in the next 6 months or menopausal women Excessive consumption of products enriched in probiotics (> 4 servings per week). History of drug or alcohol (> 2 drinks daily) abuse Abnormal thyroid hormone levels Intake of medication that could affect body weight and/or energy expenditure Family history of type 2 diabetes in first degree relatives Allergy to the ingredients in the study product and placebo Participant with anaemia Participant with a recent history of large weight fluctuations (e.g., > 10 kg in the past year Immune-compromised conditions Participant experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain Participant with co-morbidity associated with obesity: Hypertension (≥ 140/90 mm Hg) Current use of antihypertensive medications, depression Prediabetes (fasting glucose >100mg/dL) Family history of premature coronary artery disease LDL > 2.0 mmol/L HDL < 1.3 mmol/L Smoking Obstructive sleep apnea Type 2 diabetes Cardiovascular disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>daily probiotic consumption | Other: Probiotic<br>* daily probiotic consumption<br>|
| Placebo Comparator: Placebo<br>daily placebo consumption | Other: Placebo<br>* daily placebo consumption<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight; Body composition (DEXA); Waist circumference |  | PRE and POST | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Weight control, Body composition