Back to resultsThe Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Oligofructose
Maltodextrin
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Overweight, Satiety, Oligofructose, Prebiotic
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
Sites / Locations
- Samodzielny Publiczny Dziecięcy Szpital Kliniczny
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Maltodextrin
Oligofructose
Arm Description
Orafti P95, Beneo-Orafti, Belgium,
Outcomes
Primary Outcome Measures
BMI z-score difference
Secondary Outcome Measures
BMI z-score difference
Percentage of weight reduction
Difference in total body fat measured by Dual-Energy X-ray Absorptiometry (DEXA)
Percentage of children with BMI-for-age > 85percentile
Mean BMI z-score
Self-reported energy intake (3-day diet record)
Percentage of the children with abnormal fasting glucose
Percentage of the children with dyslipidemias
Percentage of the children with hypertension
Adverse effects
Full Information
NCT ID
NCT01673152
First Posted
June 27, 2012
Last Updated
January 15, 2014
Sponsor
Medical University of Warsaw
Collaborators
Nutricia Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01673152
Brief Title
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
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw
Collaborators
Nutricia Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Overweight, Satiety, Oligofructose, Prebiotic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Title
Oligofructose
Arm Type
Experimental
Arm Description
Orafti P95, Beneo-Orafti, Belgium,
Intervention Type
Dietary Supplement
Intervention Name(s)
Oligofructose
Other Intervention Name(s)
Orafti P95, Beneo-Orafti, Belgium
Intervention Description
Dosing: children aged 7 to 12 years: 8g/day, children aged 12 to18 years: 15g/day Duration: 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
Dosing: children aged 7 to 12 years: 4g/day, children aged 12 to18 years: 6g/day, Duration: 12 weeks
Primary Outcome Measure Information:
Title
BMI z-score difference
Time Frame
after 12 weeks of the intervention
Secondary Outcome Measure Information:
Title
BMI z-score difference
Time Frame
after 24 weeks of the intervention
Title
Percentage of weight reduction
Time Frame
after 12 weeks of the intervention
Title
Difference in total body fat measured by Dual-Energy X-ray Absorptiometry (DEXA)
Time Frame
after 12 weeks of the intervention
Title
Percentage of children with BMI-for-age > 85percentile
Time Frame
after 12 and 24 weeks of the intervention
Title
Mean BMI z-score
Time Frame
after 12 and 24 weeks of the intervention
Title
Self-reported energy intake (3-day diet record)
Time Frame
after 12 weeks of the intervention
Title
Percentage of the children with abnormal fasting glucose
Time Frame
after 12 weeks of the intervention
Title
Percentage of the children with dyslipidemias
Time Frame
after 12 weeks of the intervention
Title
Percentage of the children with hypertension
Time Frame
after 12 weeks of the intervention
Title
Adverse effects
Time Frame
during intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Samodzielny Publiczny Dziecięcy Szpital Kliniczny
City
Warsaw
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children
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