CClinicalTrials.gg
CompletedNCT01106924Updated May 28, 2012

Effects of a Probiotic on Body Weight

An interventional study of Probiotic and Placebo in Obesity, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-28.

Sponsored by Laval University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity

Keywords

  • Probiotics, Weight control, Body composition
03

In context

Lead sponsor

Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Probiotic

    daily probiotic consumption

    Other: Probiotic

  • Placebo comparator
    Placebo

    daily placebo consumption

    Other: Placebo

Interventions

  • OtherProbiotic

    daily probiotic consumption

  • OtherPlacebo

    daily placebo consumption

06

What researchers measure

Primary outcomes

  1. Body weight; Body composition (DEXA); Waist circumference

    Time frame: PRE and POST

07

Study locations

1 site
  • Laval University and Laval Hospital
    Québec, Quebec G1V 0A6, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01106924
Lead sponsor
Laval University
Collaborators
Société des Produits Nestlé (SPN)
Responsible party
Sponsor
First posted
Apr 20, 2010
Start date
Jan 2010
Primary completion
Apr 2012
Completion
May 2012
Last update
May 28, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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