Effects of a Probiotic on Body Weight

Laval University

Status: Completed

Conditions: Obesity

Treatments: Other: Placebo; Other: Probiotic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01106924

08.22 NRC

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

daily probiotic consumption

Treatment:

Other: Probiotic

Placebo

Placebo Comparator group

Description:

daily placebo consumption

Treatment:

Other: Placebo