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Effects of a Probiotic on Body Weight

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01106924
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : May 28, 2012
Sponsor:
Collaborator:
Nestlé
Information provided by (Responsible Party):
Laval University

Tracking Information
First Submitted Date  ICMJE April 19, 2010
First Posted Date  ICMJE April 20, 2010
Last Update Posted Date May 28, 2012
Study Start Date  ICMJE January 2010
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2010)
Body weight; Body composition (DEXA); Waist circumference [ Time Frame: PRE and POST ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of a Probiotic on Body Weight
Official Title  ICMJE Effects of Consumption of a Probiotic Formulation on Weight Control in Obese Subjects
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Other: Probiotic
    daily probiotic consumption
  • Other: Placebo
    daily placebo consumption
Study Arms  ICMJE
  • Experimental: Probiotic
    daily probiotic consumption
    Intervention: Other: Probiotic
  • Placebo Comparator: Placebo
    daily placebo consumption
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2010)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01106924
Other Study ID Numbers  ICMJE 08.22 NRC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laval University
Study Sponsor  ICMJE Laval University
Collaborators  ICMJE Nestlé
Investigators  ICMJE Not Provided
PRS Account Laval University
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP