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

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ClinicalTrials.gov Identifier: NCT02280772
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

Tracking Information
First Submitted Date  ICMJE October 29, 2014
First Posted Date  ICMJE October 31, 2014
Last Update Posted Date July 20, 2018
Actual Study Start Date  ICMJE April 27, 2015
Actual Primary Completion Date January 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2014)
BMI-for-age z-score difference [ Time Frame: 0-12 weeks ]
Baseline versus end of the intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2015)
  • 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)
  • BMI-for-age z-score difference [ Time Frame: 0-24 weeks ]
    Baseline versus end of the follow-up
  • 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)
  • 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).
  • Energy intake (kJ/d) [ Time Frame: At baseline and at week 12, week 24. ]
    Based on self-written, 3-day food records
  • Physical activity [ Time Frame: at baseline and at week 12 ]
    Measured using an accelerometer
  • Adverse events [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2014)
  • 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)
  • BMI-for-age z-score difference [ Time Frame: 0-24 weeks ]
    Baseline versus end of the follow-up
  • 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)
  • 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).
  • Energy intake (kJ/d) [ Time Frame: At baseline and at week 12, week 24. ]
    Based on self-written, 3-day food records
  • Physical activity [ Time Frame: at baseline and at week 12 ]
    Measured using an accelerometer
  • Adverse events [ Time Frame: 0-12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children
Official Title  ICMJE Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children: A Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Overweight
Intervention  ICMJE
  • Dietary Supplement: Glucomannan
    Other Name: Amorphophallus konjac
  • Dietary Supplement: Maltodextrin
Study Arms  ICMJE
  • Experimental: Glucomannan
    Glucomannan orally, 3g/day (in three divided doses), for 12 weeks
    Intervention: Dietary Supplement: Glucomannan
  • Placebo Comparator: Maltodextrin
    Maltodextrin orally, 3g/day (in three divided doses), for 12 weeks
    Intervention: Dietary Supplement: Maltodextrin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2014)
96
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 28, 2018
Actual Primary Completion Date January 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02280772
Other Study ID Numbers  ICMJE 07-2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of Warsaw
Study Sponsor  ICMJE Medical University of Warsaw
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bartlomiej M Zalewski, MD The Medical University of Warsaw
Study Chair: Hanna Szajewska, Professor The Medical University of Warsaw
PRS Account Medical University of Warsaw
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP