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Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Glucomannan
Maltodextrin
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring glucomannan, obesity, children, overweight, adolescents, treatment

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Medical University of Warsaw, Department of Paediatrics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Glucomannan

Maltodextrin

Arm Description

Glucomannan orally, 3g/day (in three divided doses), for 12 weeks

Maltodextrin orally, 3g/day (in three divided doses), for 12 weeks

Outcomes

Primary Outcome Measures

BMI-for-age z-score difference
Baseline versus end of the intervention

Secondary Outcome Measures

Body composition
Whole body fat, central body fat, fat-free mass (grams) assessed by a dual energy X-ray absorption (DXA)
BMI-for-age z-score difference
Baseline versus end of the follow-up
Proportion of participants with dyslipidemia
Proportion of participants with dyslipidemia from baseline to week 12 and week 24 (mean change, SD)
Proportion of participants with impaired fasting plasma glucose (FPG)
Proportion of participants with impaired fasting plasma glucose (FPG) from baseline to week 12 and week 24 (mean change, SD).
Energy intake (kJ/d)
Based on self-written, 3-day food records
Physical activity
Measured using an accelerometer
Adverse events
Blood pressure (systolic and diastolic)
The mean change from baseline to week 12, and week 24

Full Information

First Posted
October 29, 2014
Last Updated
July 19, 2018
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT02280772
Brief Title
Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children
Official Title
Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 27, 2015 (Actual)
Primary Completion Date
January 2, 2018 (Actual)
Study Completion Date
March 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Glucomannan (GNN), a water-soluble dietary fiber derived from the plant Amorphophallus konjac, is marketed for weight reduction. The exact mechanisms by which GNN might exert its actions are unclear. Nonetheless, it has been shown that GNN slows gastric emptying by forming a viscous gel of large volume, which increases the feeling of satiety. Current evidence on the effectiveness of GNN for weight reduction is sparse, and well-designed trials performed in children are needed to assess the efficacy of this modality. We aim to systematically evaluate the efficacy of GNN consumption for the management of overweight and obesity in children.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
glucomannan, obesity, children, overweight, adolescents, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucomannan
Arm Type
Experimental
Arm Description
Glucomannan orally, 3g/day (in three divided doses), for 12 weeks
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
Maltodextrin orally, 3g/day (in three divided doses), for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucomannan
Other Intervention Name(s)
Amorphophallus konjac
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Primary Outcome Measure Information:
Title
BMI-for-age z-score difference
Description
Baseline versus end of the intervention
Time Frame
0-12 weeks
Secondary Outcome Measure Information:
Title
Body composition
Description
Whole body fat, central body fat, fat-free mass (grams) assessed by a dual energy X-ray absorption (DXA)
Time Frame
0-13 weeks
Title
BMI-for-age z-score difference
Description
Baseline versus end of the follow-up
Time Frame
0-24 weeks
Title
Proportion of participants with dyslipidemia
Description
Proportion of participants with dyslipidemia from baseline to week 12 and week 24 (mean change, SD)
Time Frame
At baseline, 12 weeks and 24 weeks
Title
Proportion of participants with impaired fasting plasma glucose (FPG)
Description
Proportion of participants with impaired fasting plasma glucose (FPG) from baseline to week 12 and week 24 (mean change, SD).
Time Frame
At baseline, 12 weeks and 24 weeks
Title
Energy intake (kJ/d)
Description
Based on self-written, 3-day food records
Time Frame
At baseline and at week 12, week 24.
Title
Physical activity
Description
Measured using an accelerometer
Time Frame
at baseline and at week 12
Title
Adverse events
Time Frame
0-12 weeks
Title
Blood pressure (systolic and diastolic)
Description
The mean change from baseline to week 12, and week 24
Time Frame
Baseline, week 12, 24 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bartlomiej M Zalewski, MD
Organizational Affiliation
The Medical University of Warsaw
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hanna Szajewska, Professor
Organizational Affiliation
The Medical University of Warsaw
Official's Role
Study Chair
Facility Information:
Facility Name
The Medical University of Warsaw, Department of Paediatrics
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-091
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31036412
Citation
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.
Results Reference
derived
PubMed Identifier
25869689
Citation
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.
Results Reference
derived

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Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children

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