This study is designed to assess the effect of oligofructose administration for 12 weeks on Body Mass Index (BMI) of overweight and obese children.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
Dosing: children aged 7 to 12 years: 8g/day, children aged 12 to18 years: 15g/day Duration: 12 weeks
Dosing: children aged 7 to 12 years: 4g/day, children aged 12 to18 years: 6g/day, Duration: 12 weeks
Samodzielny Publiczny Dziecięcy Szpital Kliniczny
Warsaw, Poland
BMI z-score difference
Time frame: after 12 weeks of the intervention
BMI z-score difference
Time frame: after 24 weeks of the intervention
Percentage of weight reduction
Time frame: after 12 weeks of the intervention
Difference in total body fat measured by Dual-Energy X-ray Absorptiometry (DEXA)
Time frame: after 12 weeks of the intervention
Percentage of children with BMI-for-age > 85percentile
Time frame: after 12 and 24 weeks of the intervention
Mean BMI z-score
Time frame: after 12 and 24 weeks of the intervention
Self-reported energy intake (3-day diet record)
Time frame: after 12 weeks of the intervention
Percentage of the children with abnormal fasting glucose
Time frame: after 12 weeks of the intervention
Percentage of the children with dyslipidemias
Time frame: after 12 weeks of the intervention
Percentage of the children with hypertension
Time frame: after 12 weeks of the intervention
Adverse effects
Time frame: during intervention
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