Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotic

Group Type EXPERIMENTAL

Probiotic formulation

Intervention Type DIETARY_SUPPLEMENT

Twice a day for 24 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Twice a day for 24 days

Interventions

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Probiotic formulation

Twice a day for 24 days

Intervention Type DIETARY_SUPPLEMENT

Placebo

Twice a day for 24 days

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes