NCT01673152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 27, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 16, 2014

Status Verified

January 1, 2014

Enrollment Period

1.8 years

First QC Date

June 27, 2012

Last Update Submit

January 15, 2014

Conditions

Obesity

Keywords

ObesityOverweightSatietyOligofructosePrebiotic

Outcome Measures

Primary Outcomes (1)

  • BMI z-score difference

    after 12 weeks of the intervention

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

Maltodextrin

PLACEBO COMPARATOR
Dietary Supplement: Maltodextrin

Oligofructose

EXPERIMENTAL

Orafti P95, Beneo-Orafti, Belgium,

Dietary Supplement: Oligofructose

Interventions

OligofructoseDIETARY_SUPPLEMENT

Dosing: children aged 7 to 12 years: 8g/day, children aged 12 to18 years: 15g/day Duration: 12 weeks

Also known as: Orafti P95, Beneo-Orafti, Belgium
Oligofructose
MaltodextrinDIETARY_SUPPLEMENT

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

Maltodextrin

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children aged 7 to 18 years
  • BMI \> 85 percentile
  • Signed informed consent

You may not qualify if:

  • Overweight / obesity secondary to genetic syndromes and/or endocrine diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samodzielny Publiczny Dziecięcy Szpital Kliniczny

Warsaw, Poland

Location

MeSH Terms

Conditions

ObesityOverweight

Interventions

oligofructosemaltodextrin

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 27, 2012

First Posted

August 27, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 16, 2014

Record last verified: 2014-01

Locations

PL(1)