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

This study is designed to assess the effect of oligofructose administration for 12 weeks on Body Mass Index (BMI) of overweight and obese children.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Maltodextrin; Dietary supplement: Oligofructose

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.

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland
    • Samodzielny Publiczny Dzieciecy Szpital Kliniczny

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Orafti P95, Beneo-Orafti, Belgium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
BMI z-score difference	after 12 weeks of the intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
BMI z-score difference	after 24 weeks of the intervention
Percentage of weight reduction	after 12 weeks of the intervention
Difference in total body fat measured by Dual-Energy X-ray Absorptiometry (DEXA)	after 12 weeks of the intervention
Percentage of children with BMI-for-age > 85percentile	after 12 and 24 weeks of the intervention
Mean BMI z-score	after 12 and 24 weeks of the intervention
Self-reported energy intake (3-day diet record)	after 12 weeks of the intervention
Percentage of the children with abnormal fasting glucose	after 12 weeks of the intervention
Percentage of the children with dyslipidemias	after 12 weeks of the intervention
Percentage of the children with hypertension	after 12 weeks of the intervention
Adverse effects	during intervention

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Collaborators: Nutricia Foundation

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: June 27, 2012
• First Submitted That Met QC Criteria: August 23, 2012
• First Posted (Estimate): August 27, 2012

Study Record Updates

• Last Update Posted (Estimate): January 16, 2014
• Last Update Submitted That Met QC Criteria: January 15, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Prebiotic; Satiety; Oligofructose
• Additional Relevant MeSH Terms: Overweight; Body Weight
• Other Study ID Numbers: RG 4/2011