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

Phase 4

Completed

• Conditions: Overweight; Obesity
• Interventions: Dietary Supplement: Glucomannan; Dietary Supplement: Maltodextrin

• Registration Number: NCT02280772
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-10-30
• Study First Posted: 2014-10-31
• Study Start: 2015-04-27
• Status Verified: 2017-10
• Primary Completion: 2018-01-02
• Study Completion: 2018-03-28
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
BMI-for-age z-score difference	0-12 weeks	Baseline versus end of the intervention

Secondary Outcome Measures

Name	Time	Method
BMI-for-age z-score difference	0-24 weeks	Baseline versus end of the follow-up
Energy intake (kJ/d)	At baseline and at week 12, week 24.	Based on self-written, 3-day food records
Body composition	0-13 weeks	Whole body fat, central body fat, fat-free mass (grams) assessed by a dual energy X-ray absorption (DXA)
Proportion of participants with dyslipidemia	At baseline, 12 weeks and 24 weeks	Proportion of participants with dyslipidemia from baseline to week 12 and week 24 (mean change, SD)
Physical activity	at baseline and at week 12	Measured using an accelerometer
Adverse events	0-12 weeks
Proportion of participants with impaired fasting plasma glucose (FPG)	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).
Blood pressure (systolic and diastolic)	Baseline, week 12, 24 weeks.	The mean change from baseline to week 12, and week 24

Trial Locations

Locations (1)

The Medical University of Warsaw, Department of Paediatrics; 🇵🇱 Warsaw, Mazowieckie, Poland