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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
The Medical University of Warsaw, Department of Paediatrics
Warsaw, Masovian Voivodeship, Poland
BMI-for-age z-score difference
Baseline versus end of the intervention
Time frame: 0-12 weeks
Body composition
Whole body fat, central body fat, fat-free mass (grams) assessed by a dual energy X-ray absorption (DXA)
Time frame: 0-13 weeks
BMI-for-age z-score difference
Baseline versus end of the follow-up
Time frame: 0-24 weeks
Proportion of participants with dyslipidemia
Proportion of participants with dyslipidemia from baseline to week 12 and week 24 (mean change, SD)
Time frame: At baseline, 12 weeks and 24 weeks
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).
Time frame: At baseline, 12 weeks and 24 weeks
Energy intake (kJ/d)
Based on self-written, 3-day food records
Time frame: At baseline and at week 12, week 24.
Physical activity
Measured using an accelerometer
Time frame: at baseline and at week 12
Adverse events
Time frame: 0-12 weeks
Blood pressure (systolic and diastolic)
The mean change from baseline to week 12, and week 24
Time frame: Baseline, week 12, 24 weeks.
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