Clinical trial NCT01673152: The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children
Official title: The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children: a Randomized, Double Blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Overweight
Satiety
Oligofructose
Prebiotic
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Nutricia Foundation
First posted: 2012-08-27
Enrollment: 96
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: BMI z-score difference
timeFrame: after 12 weeks of the intervention
Secondary outcomes:
measure: BMI z-score difference
timeFrame: after 24 weeks of the intervention
measure: Percentage of weight reduction
timeFrame: after 12 weeks of the intervention
measure: Difference in total body fat measured by Dual-Energy X-ray Absorptiometry (DEXA)
timeFrame: after 12 weeks of the intervention
measure: Percentage of children with BMI-for-age > 85percentile
timeFrame: after 12 and 24 weeks of the intervention
measure: Mean BMI z-score
timeFrame: after 12 and 24 weeks of the intervention
measure: Self-reported energy intake (3-day diet record)
timeFrame: after 12 weeks of the intervention
measure: Percentage of the children with abnormal fasting glucose
timeFrame: after 12 weeks of the intervention
measure: Percentage of the children with dyslipidemias
timeFrame: after 12 weeks of the intervention
measure: Percentage of the children with hypertension
timeFrame: after 12 weeks of the intervention
measure: Adverse effects
timeFrame: during intervention
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Samodzielny Publiczny Dziecięcy Szpital Kliniczny
Study officials:
References: