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Effects of a Probiotic on Body Weight

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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

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.


Condition or disease Intervention/treatment Phase
Obesity Other: Probiotic Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Consumption of a Probiotic Formulation on Weight Control in Obese Subjects
Study Start Date : January 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Probiotic
daily probiotic consumption
Other: Probiotic
daily probiotic consumption
Placebo Comparator: Placebo
daily placebo consumption
Other: Placebo
daily placebo consumption



Primary Outcome Measures :
  1. Body weight; Body composition (DEXA); Waist circumference [ Time Frame: PRE and POST ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106924


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

Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT01106924     History of Changes
Other Study ID Numbers: 08.22 NRC
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: September 2011

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