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Completed

NCT Number: NCT01066260

Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects

Probiotic administration is associated with health benefits on gut barrier integrity and immunological functions of the gastrointestinal tract. Recently, probiotic consumption was proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al. 2009). Changes in energy metabolism might be involved in the effects of probiotics on weight control.

The objective of this study was to assess the efficacy of the consumption of a probiotic formulation on energy balance in overweight subjects.

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Key information

Conditions

Healthy

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Nestlé Research Center

Lausanne, Canton of Vaud, 1000, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body Masss Index (BMI) 25 - 30 kg/m2
  • Healthy (determined by medical questionnaire)
  • Able to commit to the duration of the study
  • Providing consent for participation

Exclusion criteria

  • History of cardiovascular disease (CVD), diabetes, cancer, renal, thyroid or hepatic disease
  • History of gastrointestinal surgery
  • History of sleep disorders
  • Recent bacterial infection (< 2 weeks)
  • Weight loss > 5 kg in the last 3 months
  • Under antibiotics or treatments (medical or nutritional program) affecting body weight, appetite, energy expenditure lipid-lowering, hypertension or inflammation or glucose control for the last 3 months or taking hormone replacement therapy
  • Excessive consumption of products enriched in probiotics (> 4 servings per week) within the last 4 weeks before the start of the study
  • History of drug or alcohol abuse (> 2 drinks daily)
  • Regular smokers (more than 5 cigarettes a day)
  • Not eating breakfast regularly or eating breakfast before 6h00.
  • Not willing to eat any of the foods to be served in the study for any reason
  • Physical activity level > 150 min of moderate or intense exercise per week
  • Concurrent or recent intervention study (within 60 days)

Treatment and study plan

Probiotic formulation

Dietary Supplement

Twice a day for 24 days

Placebo

Other

Twice a day for 24 days

Primary outcomes

  1. Energy intake

    Time frame: Lunch

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 10, 2010
Registry last updated
Jun 4, 2013

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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