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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-27

Study Completion Date

2018-03-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Glucomannan

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

Group Type EXPERIMENTAL

Glucomannan

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

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

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Glucomannan

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Amorphophallus konjac

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No