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

Study Overview
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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.

Official Title
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The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children: a Randomized, Double Blind, Placebo-controlled Trial

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Oligofructose
* Dietary Supplement: Maltodextrin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Maltodextrin<br> | Dietary Supplement: Maltodextrin<br>* Dosing: children aged 7 to 12 years: 4g/day, children aged 12 to18 years: 6g/day, Duration: 12 weeks<br>|
| Experimental: Oligofructose<br>Orafti P95, Beneo-Orafti, Belgium, | Dietary Supplement: Oligofructose<br>* Dosing: children aged 7 to 12 years: 8g/day, children aged 12 to18 years: 15g/day Duration: 12 weeks<br>* Other names: Orafti P95, Beneo-Orafti, Belgium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI z-score difference |  | after 12 weeks of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI z-score difference |  | after 24 weeks of the intervention | 
| Percentage of weight reduction |  | after 12 weeks of the intervention | 
| Difference in total body fat measured by Dual-Energy X-ray Absorptiometry (DEXA) |  | after 12 weeks of the intervention | 
| Percentage of children with BMI-for-age > 85percentile |  | after 12 and 24 weeks of the 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 the children with abnormal fasting glucose |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Overweight, Satiety, Oligofructose, Prebiotic