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Trial record 49 of 575 for:    maltodextrin

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

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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Dietary Supplement: Glucomannan Dietary Supplement: Maltodextrin Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children: A Randomized Controlled Trial
Actual Study Start Date : April 27, 2015
Actual Primary Completion Date : January 2, 2018
Actual Study Completion Date : March 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Glucomannan
Glucomannan orally, 3g/day (in three divided doses), for 12 weeks
Dietary Supplement: Glucomannan
Other Name: Amorphophallus konjac

Placebo Comparator: Maltodextrin
Maltodextrin orally, 3g/day (in three divided doses), for 12 weeks
Dietary Supplement: Maltodextrin



Primary Outcome Measures :
  1. BMI-for-age z-score difference [ Time Frame: 0-12 weeks ]
    Baseline versus end of the intervention


Secondary Outcome Measures :
  1. 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)

  2. BMI-for-age z-score difference [ Time Frame: 0-24 weeks ]
    Baseline versus end of the follow-up

  3. 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)

  4. 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).

  5. Energy intake (kJ/d) [ Time Frame: At baseline and at week 12, week 24. ]
    Based on self-written, 3-day food records

  6. Physical activity [ Time Frame: at baseline and at week 12 ]
    Measured using an accelerometer

  7. Adverse events [ Time Frame: 0-12 weeks ]
  8. Blood pressure (systolic and diastolic) [ Time Frame: Baseline, week 12, 24 weeks. ]
    The mean change from baseline to week 12, and week 24



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280772


Locations
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Poland
The Medical University of Warsaw, Department of Paediatrics
Warsaw, Mazowieckie, Poland, 02-091
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Principal Investigator: Bartlomiej M Zalewski, MD The Medical University of Warsaw
Study Chair: Hanna Szajewska, Professor The Medical University of Warsaw

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02280772     History of Changes
Other Study ID Numbers: 07-2014
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: October 2017
Keywords provided by Medical University of Warsaw:
glucomannan
obesity
children
overweight
adolescents
treatment
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms
(1-6)-alpha-glucomannan
Cathartics
Gastrointestinal Agents