Clinical trial NCT02280772: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Overweight
Keywords: glucomannan
obesity
children
overweight
adolescents
treatment
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 96
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: BMI-for-age z-score difference
timeFrame: 0-12 weeks
Secondary outcomes:
measure: Body composition
timeFrame: 0-13 weeks
measure: BMI-for-age z-score difference
timeFrame: 0-24 weeks
measure: Proportion of participants with dyslipidemia
timeFrame: At baseline, 12 weeks and 24 weeks
measure: Proportion of participants with impaired fasting plasma glucose (FPG)
timeFrame: At baseline, 12 weeks and 24 weeks
measure: Energy intake (kJ/d)
timeFrame: At baseline and at week 12, week 24.
measure: Physical activity
timeFrame: at baseline and at week 12
measure: Adverse events
timeFrame: 0-12 weeks
measure: Blood pressure (systolic and diastolic)
timeFrame: Baseline, week 12, 24 weeks.
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: The Medical University of Warsaw, Department of Paediatrics
state: Mazowieckie
Study officials:
affiliation: The Medical University of Warsaw
name: Bartlomiej M Zalewski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Medical University of Warsaw
name: Hanna Szajewska, Professor
role: STUDY_CHAIR
References:
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.
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.