The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children
This study is currently recruiting participants.
Verified August 2012 by Medical University of Warsaw
Sponsor:
Medical University of Warsaw
Collaborator:
Nutricia Foundation
Information provided by (Responsible Party):
Hanna Szajewska, Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01673152
First received: June 27, 2012
Last updated: August 23, 2012
Last verified: August 2012
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Purpose
This study is designed to assess the effect of oligofructose administration for 12 weeks on Body Mass Index (BMI) of overweight and obese children.
| Condition | Intervention |
|---|---|
|
Obesity |
Dietary Supplement: Oligofructose Dietary Supplement: Maltodextrin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children: a Randomized, Double Blind, Placebo-controlled Trial |
Resource links provided by NLM:
Further study details as provided by Medical University of Warsaw:
Primary Outcome Measures:
- BMI z-score difference [ Time Frame: after 12 weeks of the intervention ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- BMI z-score difference [ Time Frame: after 24 weeks of the intervention ] [ Designated as safety issue: No ]
- Percentage of weight reduction [ Time Frame: after 12 weeks of the intervention ] [ Designated as safety issue: No ]
- Difference in total body fat measured by Dual-Energy X-ray Absorptiometry (DEXA) [ Time Frame: after 12 weeks of the intervention ] [ Designated as safety issue: No ]
- Percentage of children with BMI-for-age > 85percentile [ Time Frame: after 12 and 24 weeks of the intervention ] [ Designated as safety issue: No ]
- Mean BMI z-score [ Time Frame: after 12 and 24 weeks of the intervention ] [ Designated as safety issue: No ]
- Self-reported energy intake (3-day diet record) [ Time Frame: after 12 weeks of the intervention ] [ Designated as safety issue: No ]
- Percentage of the children with abnormal fasting glucose [ Time Frame: after 12 weeks of the intervention ] [ Designated as safety issue: No ]
- Percentage of the children with dyslipidemias [ Time Frame: after 12 weeks of the intervention ] [ Designated as safety issue: No ]
- Percentage of the children with hypertension [ Time Frame: after 12 weeks of the intervention ] [ Designated as safety issue: No ]
- Adverse effects [ Time Frame: during intervention ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 96 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Maltodextrin |
Dietary Supplement: Maltodextrin
Dosing: children aged 7 to 12 years: 4g/day, children aged 12 to18 years: 6g/day, Duration: 12 weeks
|
|
Experimental: Oligofructose
Orafti P95, Beneo-Orafti, Belgium,
|
Dietary Supplement: Oligofructose
Dosing: children aged 7 to 12 years: 8g/day, children aged 12 to18 years: 15g/day Duration: 12 weeks
Other Name: Orafti P95, Beneo-Orafti, Belgium
|
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| Ages Eligible for Study: | 7 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673152
Locations
| Poland | |
| Samodzielny Publiczny Dziecięcy Szpital Kliniczny | Recruiting |
| Warsaw, Poland | |
| Contact: Anna Liber, MD anna.liber@wp.pl | |
| Sub-Investigator: Anna Liber, MD | |
Sponsors and Collaborators
Medical University of Warsaw
Nutricia Foundation
More Information
No publications provided
| Responsible Party: | Hanna Szajewska, Professor, Medical University of Warsaw |
| ClinicalTrials.gov Identifier: | NCT01673152 History of Changes |
| Other Study ID Numbers: | RG 4/2011 |
| Study First Received: | June 27, 2012 |
| Last Updated: | August 23, 2012 |
| Health Authority: | Poland: Ethics Committee |
Keywords provided by Medical University of Warsaw:
|
Obesity Overweight Satiety Oligofructose Prebiotic |
Additional relevant MeSH terms:
|
Body Weight Obesity Overweight |
Signs and Symptoms Overnutrition Nutrition Disorders |
ClinicalTrials.gov processed this record on May 21, 2013