Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01066260

Enrollment

Registered

2010-02-10

Start date

2009-10-31

Completion date

2010-09-30

Last updated

2013-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Probiotics, Energy balance

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTProbiotic formulation

Twice a day for 24 days

OTHERPlacebo

Twice a day for 24 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Energy intake	Lunch

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026