NCT02280772

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4 obesity

Timeline
Completed

Started Apr 2015

Typical duration for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

April 27, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2018

Completed
Last Updated

July 20, 2018

Status Verified

October 1, 2017

Enrollment Period

2.7 years

First QC Date

October 29, 2014

Last Update Submit

July 19, 2018

Conditions

ObesityOverweight

Keywords

glucomannanobesitychildrenoverweightadolescentstreatment

Outcome Measures

Primary Outcomes (1)

  • BMI-for-age z-score difference

    Baseline versus end of the intervention

    0-12 weeks

Secondary Outcomes (8)

  • Body composition

    0-13 weeks

  • BMI-for-age z-score difference

    0-24 weeks

  • Proportion of participants with dyslipidemia

    At baseline, 12 weeks and 24 weeks

  • Proportion of participants with impaired fasting plasma glucose (FPG)

    At baseline, 12 weeks and 24 weeks

  • Energy intake (kJ/d)

    At baseline and at week 12, week 24.

  • +3 more secondary outcomes

Study Arms (2)

Glucomannan

EXPERIMENTAL

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

Dietary Supplement: Glucomannan

Maltodextrin

PLACEBO COMPARATOR

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

Dietary Supplement: Maltodextrin

Interventions

GlucomannanDIETARY_SUPPLEMENT
Also known as: Amorphophallus konjac
Glucomannan
MaltodextrinDIETARY_SUPPLEMENT
Maltodextrin

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Medical University of Warsaw, Department of Paediatrics

Warsaw, Masovian Voivodeship, 02-091, Poland

Location

Related Publications (2)

  • 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.

    PMID: 31036412DERIVED

  • 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.

    PMID: 25869689DERIVED

MeSH Terms

Conditions

ObesityOverweight

Interventions

(1-6)-alpha-glucomannanAmorphophallus konjac root extractmaltodextrin

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bartlomiej M Zalewski, MD

    The Medical University of Warsaw

    PRINCIPAL INVESTIGATOR

  • Hanna Szajewska, Professor

    The Medical University of Warsaw

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2014

First Posted

October 31, 2014

Study Start

April 27, 2015

Primary Completion

January 2, 2018

Study Completion

March 28, 2018

Last Updated

July 20, 2018

Record last verified: 2017-10

Locations

PL(1)