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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Maltodextrin; Dietary Supplement: Oligofructose

• Registration Number: NCT01673152
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-06-27
• Study First Submitted QC: 2012-08-23
• Study First Posted: 2012-08-27
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-15
• Last Update Posted: 2014-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maltodextrin	Maltodextrin	-
Oligofructose	Oligofructose	Orafti P95, Beneo-Orafti, Belgium,

Primary Outcome Measures

Name	Time	Method
BMI z-score difference	after 12 weeks of the intervention

Secondary Outcome Measures

Name	Time	Method
Percentage of weight reduction	after 12 weeks of the intervention
Percentage of the children with dyslipidemias	after 12 weeks of the intervention
Percentage of the children with hypertension	after 12 weeks of the intervention
Adverse effects	during intervention
Mean BMI z-score	after 12 and 24 weeks of the intervention
Self-reported energy intake (3-day diet record)	after 12 weeks of the intervention
Percentage of children with BMI-for-age > 85percentile	after 12 and 24 weeks of the intervention
Percentage of the children with abnormal fasting glucose	after 12 weeks of the intervention
BMI z-score difference	after 24 weeks of the intervention
Difference in total body fat measured by Dual-Energy X-ray Absorptiometry (DEXA)	after 12 weeks of the intervention

Trial Locations

Locations (1)

Samodzielny Publiczny Dziecięcy Szpital Kliniczny; 🇵🇱 Warsaw, Poland