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

Obesity Clinical Trial

Official title:

The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children: a Randomized, Double Blind, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673152
• Other study ID #: RG 4/2011
• Status: Completed
• Phase: N/A
• First received: June 27, 2012
• Last updated: January 15, 2014
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight

Intervention

Dietary Supplement:
• Oligofructose
Dosing: children aged 7 to 12 years: 8g/day, children aged 12 to18 years: 15g/day Duration: 12 weeks
• Maltodextrin
Dosing: children aged 7 to 12 years: 4g/day, children aged 12 to18 years: 6g/day, Duration: 12 weeks

Locations

Country	Name	City	State
Poland	Samodzielny Publiczny Dzieciecy Szpital Kliniczny	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Nutricia Foundation

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI z-score difference		after 12 weeks of the intervention	No
Secondary	BMI z-score difference		after 24 weeks of the intervention	No
Secondary	Percentage of weight reduction		after 12 weeks of the intervention	No
Secondary	Difference in total body fat measured by Dual-Energy X-ray Absorptiometry (DEXA)		after 12 weeks of the intervention	No
Secondary	Percentage of children with BMI-for-age > 85percentile		after 12 and 24 weeks of the intervention	No
Secondary	Mean BMI z-score		after 12 and 24 weeks of the intervention	No
Secondary	Self-reported energy intake (3-day diet record)		after 12 weeks of the intervention	No
Secondary	Percentage of the children with abnormal fasting glucose		after 12 weeks of the intervention	No
Secondary	Percentage of the children with dyslipidemias		after 12 weeks of the intervention	No
Secondary	Percentage of the children with hypertension		after 12 weeks of the intervention	No
Secondary	Adverse effects		during intervention	Yes