Obesity
Conditions
Keywords
Obesity, Overweight, Satiety, Oligofructose, Prebiotic
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.
Interventions
DIETARY_SUPPLEMENTOligofructose
Dosing: children aged 7 to 12 years: 8g/day, children aged 12 to18 years: 15g/day Duration: 12 weeks
DIETARY_SUPPLEMENTMaltodextrin
Dosing: children aged 7 to 12 years: 4g/day, children aged 12 to18 years: 6g/day, Duration: 12 weeks
Sponsors
Nutricia Foundation
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMI z-score difference | after 12 weeks of the intervention |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| BMI z-score difference | after 24 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 |
| Self-reported energy intake (3-day diet record) | after 12 weeks of the intervention |
Countries
Poland
Outcome results
None listed