The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children

This study has been completed.
Sponsor:
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: January 15, 2014
Last verified: January 2014
  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
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673152

Locations
Poland
Samodzielny Publiczny Dziecięcy Szpital Kliniczny
Warsaw, Poland
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: January 15, 2014
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Warsaw:
Obesity
Overweight
Satiety
Oligofructose
Prebiotic

Additional relevant MeSH terms:
Obesity
Overweight
Body Weight
Overnutrition
Nutrition Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014