- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02280772
Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children
Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Methods and analysis
Children aged 6 to 17 years with overweight and obesity (based on the WHO growth criteria) will be randomly assigned to receive GNN or placebo (maltodextrin) (both at a dose of 3 g/day) for 3 months and will be followed up for 3 months. Prior to the intervention, all children will receive dietetic advice, and they will be encouraged to engage in physical activity. The primary outcome measure will be the BMI-for-age z-score difference between the groups at the end of the intervention.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Mazowieckie
-
Warsaw, Mazowieckie, Poland, 02-091
- The Medical University of Warsaw, Department of Paediatrics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 6-17 years;
- overweight or obesity based on the WHO (World Health Organization) growth charts/references (>+1 standard deviation [SD] or >+2 SD, respectively)
Exclusion Criteria:
- drug therapy for a chronic disease (including drugs that influence appetite or body weight);
- type 1 or 2 diabetes;
- history of surgical treatment of obesity;
- participation in another program for treating obesity during the project and/or 3 months prior to recruitment;
- secondary causes of obesity;
- pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Glucomannan
Glucomannan orally, 3g/day (in three divided doses), for 12 weeks
|
Other Names:
|
Placebo Comparator: Maltodextrin
Maltodextrin orally, 3g/day (in three divided doses), for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI-for-age z-score difference
Time Frame: 0-12 weeks
|
Baseline versus end of the intervention
|
0-12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body composition
Time Frame: 0-13 weeks
|
Whole body fat, central body fat, fat-free mass (grams) assessed by a dual energy X-ray absorption (DXA)
|
0-13 weeks
|
BMI-for-age z-score difference
Time Frame: 0-24 weeks
|
Baseline versus end of the follow-up
|
0-24 weeks
|
Proportion of participants with dyslipidemia
Time Frame: At baseline, 12 weeks and 24 weeks
|
Proportion of participants with dyslipidemia from baseline to week 12 and week 24 (mean change, SD)
|
At baseline, 12 weeks and 24 weeks
|
Proportion of participants with impaired fasting plasma glucose (FPG)
Time Frame: At baseline, 12 weeks and 24 weeks
|
Proportion of participants with impaired fasting plasma glucose (FPG) from baseline to week 12 and week 24 (mean change, SD).
|
At baseline, 12 weeks and 24 weeks
|
Energy intake (kJ/d)
Time Frame: At baseline and at week 12, week 24.
|
Based on self-written, 3-day food records
|
At baseline and at week 12, week 24.
|
Physical activity
Time Frame: at baseline and at week 12
|
Measured using an accelerometer
|
at baseline and at week 12
|
Adverse events
Time Frame: 0-12 weeks
|
0-12 weeks
|
|
Blood pressure (systolic and diastolic)
Time Frame: Baseline, week 12, 24 weeks.
|
The mean change from baseline to week 12, and week 24
|
Baseline, week 12, 24 weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bartlomiej M Zalewski, MD, The Medical University of Warsaw
- Study Chair: Hanna Szajewska, Professor, The Medical University of Warsaw
Publications and helpful links
General Publications
- Zalewski BM, Szajewska H. No Effect of Glucomannan on Body Weight Reduction in Children and Adolescents with Overweight and Obesity: A Randomized Controlled Trial. J Pediatr. 2019 Aug;211:85-91.e1. doi: 10.1016/j.jpeds.2019.03.044. Epub 2019 Apr 26.
- Zalewski BM, Szajewska H. Effect of glucomannan supplementation on body weight in overweight and obese children: protocol of a randomised controlled trial. BMJ Open. 2015 Apr 13;5(4):e007244. doi: 10.1136/bmjopen-2014-007244.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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