Effects of a Probiotic on Body Weight

NCT01106924 | Completed

• 1 other identifier: 08.22 NRC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Probiotics, Weight control, Body composition

Outcome Measures

Primary Outcomes (1)

• Body weight; Body composition (DEXA); Waist circumference

  PRE and POST

Study Arms (2)

Probiotic

EXPERIMENTAL

daily probiotic consumption

Other: Probiotic

Placebo

PLACEBO COMPARATOR

daily placebo consumption

Other: Placebo

Interventions

Probiotic OTHER

daily probiotic consumption

Probiotic

Placebo OTHER

daily placebo consumption

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Laval University: lead
• Société des Produits Nestlé (SPN): collaborator

Study Sites (1)

Laval University and Laval Hospital

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: April 20, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 28, 2012

Record last verified: 2011-09

Locations

CA (1)