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OpenTrials
Completed

NCT Number: NCT01106924

Effects of a Probiotic on Body Weight

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laval University and Laval Hospital

Québec, Quebec, G1V 0A6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Other

daily probiotic consumption

Placebo

Other

daily placebo consumption

Primary outcomes

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

    Time frame: PRE and POST

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Société des Produits Nestlé (SPN)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2010
Registry last updated
May 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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