ObesityNCT01673152
The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children
A study testing Oligofructose and Maltodextrin in people with Obesity, run by Medical University of Warsaw at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Oligofructose and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children aged 7 to 18 years
- BMI > 85 percentile
- Signed informed consent
Who cannot join
- Overweight / obesity secondary to genetic syndromes and/or endocrine diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Oligofructose, Maltodextrin
- Keywords
- Obesity, Overweight, Satiety, Oligofructose, Prebiotic
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OligofructoseDietary supplement
Also called Orafti P95, Beneo-Orafti, Belgium
Dosing: children aged 7 to 12 years: 8g/day, children aged 12 to18 years: 15g/day Duration: 12 weeks
MaltodextrinDietary supplement
Dosing: children aged 7 to 12 years: 4g/day, children aged 12 to18 years: 6g/day, Duration: 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Maltodextrin | Placebo comparator | Not described Receives: Dietary Supplement: Maltodextrin |
| Oligofructose | Experimental | Orafti P95, Beneo-Orafti, Belgium, Receives: Dietary Supplement: Oligofructose |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI z-score difference
Measured: after 12 weeks of the intervention
Secondary outcomes (10)
BMI z-score difference
Measured: after 24 weeks of the intervention
Percentage of weight reduction
Measured: after 12 weeks of the intervention
Difference in total body fat measured by Dual-Energy X-ray Absorptiometry (DEXA)
Measured: after 12 weeks of the intervention
Percentage of children with BMI-for-age > 85percentile
Measured: after 12 and 24 weeks of the intervention
Mean BMI z-score
Measured: after 12 and 24 weeks of the intervention
Self-reported energy intake (3-day diet record)
Measured: after 12 weeks of the intervention
Percentage of the children with abnormal fasting glucose
Measured: after 12 weeks of the intervention
Percentage of the children with dyslipidemias
Measured: after 12 weeks of the intervention
Percentage of the children with hypertension
Measured: after 12 weeks of the intervention
Adverse effects
Measured: during intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia Foundation
- Responsible party
- Principal investigator, Hanna Szajewska, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673152
- Sponsor's protocol ID
- RG 4/2011
- Status last verified
- Jan 2014
- First submitted
- 27 Jun 2012
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children: a Randomized, Double Blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01673152
- Acronym / sponsor ID
- RG 4/2011
- Conditions
- Obesity
- Keywords
- Obesity, Overweight, Satiety, Oligofructose, Prebiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Nutricia Foundation
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the effect of oligofructose administration for 12 weeks on Body Mass Index (BMI) of overweight and obese children.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrin |
| Oligofructose | Experimental | Dietary Supplement: OligofructoseOrafti P95, Beneo-Orafti, Belgium, |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children aged 7 to 18 years
- BMI > 85 percentile
- Signed informed consent
Key exclusion criteria (1 listed)
- Overweight / obesity secondary to genetic syndromes and/or endocrine diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OligofructoseAlso: Orafti P95, Beneo-Orafti, BelgiumDosing: children aged 7 to 12 years: 8g/day, children aged 12 to18 years: 15g/day Duration: 12 weeks | Dietary supplement | Oligofructose |
| MaltodextrinDosing: children aged 7 to 12 years: 4g/day, children aged 12 to18 years: 6g/day, Duration: 12 weeks | Dietary supplement | Maltodextrin |
Primary outcome
BMI z-score difference
Time frame: after 12 weeks of the intervention
10 secondary outcomes
BMI z-score difference
Time frame: after 24 weeks of the intervention
Percentage of weight reduction
Time frame: after 12 weeks of the intervention
Difference in total body fat measured by Dual-Energy X-ray Absorptiometry (DEXA)
Time frame: after 12 weeks of the intervention
Percentage of children with BMI-for-age > 85percentile
Time frame: after 12 and 24 weeks of the intervention
Mean BMI z-score
Time frame: after 12 and 24 weeks of the intervention
Self-reported energy intake (3-day diet record)
Time frame: after 12 weeks of the intervention
Percentage of the children with abnormal fasting glucose
Time frame: after 12 weeks of the intervention
Percentage of the children with dyslipidemias
Time frame: after 12 weeks of the intervention
Percentage of the children with hypertension
Time frame: after 12 weeks of the intervention
Adverse effects
Time frame: during intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oligofructose and Maltodextrin in people with Obesity, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI z-score difference (time frame: after 12 weeks of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2014.