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

NCT ID: NCT01673152

Last Updated: 2014-01-16

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

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity

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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Maltodextrin

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Dosing: children aged 7 to 12 years: 4g/day, children aged 12 to18 years: 6g/day, Duration: 12 weeks

Oligofructose

Orafti P95, Beneo-Orafti, Belgium,

Group Type EXPERIMENTAL

Oligofructose

Intervention Type DIETARY_SUPPLEMENT

Dosing: children aged 7 to 12 years: 8g/day, children aged 12 to18 years: 15g/day Duration: 12 weeks

Interventions

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Oligofructose

Dosing: children aged 7 to 12 years: 8g/day, children aged 12 to18 years: 15g/day Duration: 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Dosing: children aged 7 to 12 years: 4g/day, children aged 12 to18 years: 6g/day, Duration: 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Orafti P95, Beneo-Orafti, Belgium

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nutricia Foundation

OTHER

Sponsor Role collaborator

Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Hanna Szajewska

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samodzielny Publiczny Dziecięcy Szpital Kliniczny

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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RG 4/2011

Identifier Type: -

Identifier Source: org_study_id

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