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NCT Number: NCT02280772

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

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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Medical University of Warsaw, Department of Paediatrics

Warsaw, Masovian Voivodeship, 02-091, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

glucomannan

Dietary Supplement

Other names: Amorphophallus konjac

Maltodextrin

Dietary Supplement

Primary outcomes

  1. BMI-for-age z-score difference

    Time frame: 0-12 weeks

    Baseline versus end of the intervention

Secondary outcomes

  1. Body composition

    Time frame: 0-13 weeks

    Whole body fat, central body fat, fat-free mass (grams) assessed by a dual energy X-ray absorption (DXA)

  2. BMI-for-age z-score difference

    Time frame: 0-24 weeks

    Baseline versus end of the follow-up

  3. Proportion of participants with dyslipidemia

    Time frame: At baseline, 12 weeks and 24 weeks

    Proportion of participants with dyslipidemia from baseline to week 12 and week 24 (mean change, SD)

  4. Proportion of participants with impaired fasting plasma glucose (FPG)

    Time frame: 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).

  5. Energy intake (kJ/d)

    Time frame: At baseline and at week 12, week 24.

    Based on self-written, 3-day food records

  6. Physical activity

    Time frame: at baseline and at week 12

    Measured using an accelerometer

  7. Adverse events

    Time frame: 0-12 weeks

  8. Blood pressure (systolic and diastolic)

    Time frame: Baseline, week 12, 24 weeks.

    The mean change from baseline to week 12, and week 24

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 31, 2014
Registry last updated
Jul 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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