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

Obesity Clinical Trial

Official title:

Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280772
• Other study ID #: 07-2014
• Status: Completed
• Phase: Phase 4
• Start date: April 27, 2015
• Est. completion date: March 28, 2018

Study information

• Verified date: October 2017
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 28, 2018
• Est. primary completion date: January 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight

Intervention

Dietary Supplement:
• Glucomannan

• Maltodextrin

Locations

Country	Name	City	State
Poland	The Medical University of Warsaw, Department of Paediatrics	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

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