Obesity, Overweight
Conditions
Keywords
glucomannan, obesity, children, overweight, adolescents, treatment
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.
Interventions
DIETARY_SUPPLEMENTGlucomannan
DIETARY_SUPPLEMENTMaltodextrin
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI-for-age z-score difference | 0-12 weeks | Baseline versus end of the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI-for-age z-score difference | 0-24 weeks | Baseline versus end of the follow-up |
| 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) |
| 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). |
| Body composition | 0-13 weeks | Whole body fat, central body fat, fat-free mass (grams) assessed by a dual energy X-ray absorption (DXA) |
| Physical activity | at baseline and at week 12 | Measured using an accelerometer |
| Adverse events | 0-12 weeks | — |
| Blood pressure (systolic and diastolic) | Baseline, week 12, 24 weeks. | The mean change from baseline to week 12, and week 24 |
| Energy intake (kJ/d) | At baseline and at week 12, week 24. | Based on self-written, 3-day food records |
Countries
Poland
Outcome results
None listed