Effects of a Probiotic on Body Weight

May 25, 2012 updated by: Laval University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 0A6
        • Laval University and Laval Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic
daily probiotic consumption
Other: Probiotic
daily probiotic consumption
Placebo Comparator: Placebo
daily placebo consumption
Other: Placebo
daily placebo consumption

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Nestlé

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

April 19, 2010

First Submitted That Met QC Criteria

April 19, 2010

First Posted (Estimate)

April 20, 2010

Study Record Updates

Last Update Posted (Estimate)

May 28, 2012

Last Update Submitted That Met QC Criteria

May 25, 2012

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 08.22 NRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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