Trials / Completed
CompletedNCT01673152
The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children
The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children: a Randomized, Double Blind, Placebo-controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- Sponsor
- Medical University of Warsaw · Academic / Other
- Sex
- All
- Age
- 7 Years – 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Oligofructose | Dosing: children aged 7 to 12 years: 8g/day, children aged 12 to18 years: 15g/day Duration: 12 weeks |
| DIETARY_SUPPLEMENT | Maltodextrin | Dosing: children aged 7 to 12 years: 4g/day, children aged 12 to18 years: 6g/day, Duration: 12 weeks |
Timeline
- Start date
- 2012-02-01
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
- First posted
- 2012-08-27
- Last updated
- 2014-01-16
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT01673152. Inclusion in this directory is not an endorsement.