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Completed

NCT Number: NCT01673152

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

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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samodzielny Publiczny Dziecięcy Szpital Kliniczny

Warsaw, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oligofructose

Dietary Supplement

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

Maltodextrin

Dietary Supplement

Dosing: children aged 7 to 12 years: 4g/day, children aged 12 to18 years: 6g/day, Duration: 12 weeks

Primary outcomes

  1. BMI z-score difference

    Time frame: after 12 weeks of the intervention

Secondary outcomes

  1. BMI z-score difference

    Time frame: after 24 weeks of the intervention

  2. Percentage of weight reduction

    Time frame: after 12 weeks of the intervention

  3. Difference in total body fat measured by Dual-Energy X-ray Absorptiometry (DEXA)

    Time frame: after 12 weeks of the intervention

  4. Percentage of children with BMI-for-age > 85percentile

    Time frame: after 12 and 24 weeks of the intervention

  5. Mean BMI z-score

    Time frame: after 12 and 24 weeks of the intervention

  6. Self-reported energy intake (3-day diet record)

    Time frame: after 12 weeks of the intervention

  7. Percentage of the children with abnormal fasting glucose

    Time frame: after 12 weeks of the intervention

  8. Percentage of the children with dyslipidemias

    Time frame: after 12 weeks of the intervention

  9. Percentage of the children with hypertension

    Time frame: after 12 weeks of the intervention

  10. Adverse effects

    Time frame: during intervention

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Collaborators

  • Nutricia Foundation

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 27, 2012
Registry last updated
Jan 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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