The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children

Medical University of Warsaw

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Oligofructose; Dietary Supplement: Maltodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT01673152

RG 4/2011

Details and patient eligibility

About

This study is designed to assess the effect of oligofructose administration for 12 weeks on Body Mass Index (BMI) of overweight and obese children.

Full description

The prevalence of childhood overweight and obesity is reaching epidemic proportions. There have been no effective methods for preventing or treating obesity in childhood so far prompting interest in new interventions. One potential option for obesity prevention is the use of the prebiotic oligofructose. Data from research on rodents shows that a high-fat diet enriched with oligofructose causes a decrease in energy intake, less weight gain and a lower level of triglycerides . A similar effect has been observed in healthy adults. Available evidence suggests that the addition of oligofructose to the diets of overweight or obese adults may increase satiety and thus reduce energy intake. Currently, there are no data on the effect of oligofructose in overweight and obese children.

Enrollment: 96 estimated patients

Sex: All

Ages: 7 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children aged 7 to 18 years
• BMI > 85 percentile
• Signed informed consent

Exclusion criteria

• Overweight / obesity secondary to genetic syndromes and/or endocrine diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

Maltodextrin

Placebo Comparator group

Treatment:

Dietary Supplement: Maltodextrin

Oligofructose

Experimental group

Description:

Orafti P95, Beneo-Orafti, Belgium,

Treatment:

Dietary Supplement: Oligofructose