Effects of a Probiotic on Body Weight

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: Probiotic; Other: Placebo

• Registration Number: NCT01106924
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Status Verified: 2011-09
• Primary Completion: 2012-04
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-25
• Last Update Posted: 2012-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	daily probiotic consumption
Placebo	Placebo	daily placebo consumption

Primary Outcome Measures

Name	Time	Method
Body weight; Body composition (DEXA); Waist circumference	PRE and POST

Trial Locations

Locations (1)

Laval University and Laval Hospital; 🇨🇦 Québec, Quebec, Canada