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Effects of a Probiotic on Body Weight

This study has been completed.
Sponsor:
Collaborator:
Nestlé
Information provided by (Responsible Party):
Laval University
ClinicalTrials.gov Identifier:
NCT01106924
First received: April 19, 2010
Last updated: May 25, 2012
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Other: Probiotic
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Consumption of a Probiotic Formulation on Weight Control in Obese Subjects

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Laval University:

Primary Outcome Measures:
  • Body weight; Body composition (DEXA); Waist circumference [ Time Frame: PRE and POST ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: January 2010
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic
daily probiotic consumption
 Other: Probiotic
daily probiotic consumption
Placebo Comparator: Placebo
daily placebo consumption
 Other: Placebo
daily placebo consumption

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106924

Locations
Canada, Quebec
Laval University and Laval Hospital
Québec, Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
Nestlé
  More Information

No publications provided

Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT01106924     History of Changes
Other Study ID Numbers: 08.22 NRC
Study First Received: April 19, 2010
Last Updated: May 25, 2012
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Health Canada

Keywords provided by Laval University:
Probiotics, Weight control, Body composition

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013