Clinical trial NCT01106924: Effects of a Probiotic on Body Weight
Official title: Effects of Consumption of a Probiotic Formulation on Weight Control in Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Probiotics, Weight control, Body composition
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Société des Produits Nestlé (SPN)
First posted: 2010-04-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Body weight; Body composition (DEXA); Waist circumference
timeFrame: PRE and POST
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Laval University and Laval Hospital
state: Quebec
Study officials:
References: