Effects of a Probiotic on Body Weight

NCT ID: NCT01106924

Last Updated: 2012-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-05-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotic

daily probiotic consumption

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: OTHER

daily probiotic consumption

Placebo

daily placebo consumption

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

daily placebo consumption

Interventions

Probiotic

daily probiotic consumption

Intervention Type: OTHER

Placebo

daily placebo consumption

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Laval University and Laval Hospital

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

08.22 NRC

Identifier Type: -

Identifier Source: org_study_id