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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucomannan | Experimental | Glucomannan orally, 3g/day (in three divided doses), for 12 weeks |
|
| Maltodextrin | Placebo Comparator | Maltodextrin orally, 3g/day (in three divided doses), for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucomannan | Dietary Supplement |
|
| |
| Maltodextrin |
| Measure | Description | Time Frame |
|---|---|---|
| BMI-for-age z-score difference | Baseline versus end of the intervention | 0-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Whole body fat, central body fat, fat-free mass (grams) assessed by a dual energy X-ray absorption (DXA) | 0-13 weeks |
| BMI-for-age z-score difference | Baseline versus end of the follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bartlomiej M Zalewski, MD | The Medical University of Warsaw | Principal Investigator |
| Hanna Szajewska, Professor | The Medical University of Warsaw | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Medical University of Warsaw, Department of Paediatrics | Warsaw | Masovian Voivodeship | 02-091 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31036412 | Derived | Zalewski BM, Szajewska H. No Effect of Glucomannan on Body Weight Reduction in Children and Adolescents with Overweight and Obesity: A Randomized Controlled Trial. J Pediatr. 2019 Aug;211:85-91.e1. doi: 10.1016/j.jpeds.2019.03.044. Epub 2019 Apr 26. | |
| 25869689 | Derived | Zalewski BM, Szajewska H. Effect of glucomannan supplementation on body weight in overweight and obese children: protocol of a randomised controlled trial. BMJ Open. 2015 Apr 13;5(4):e007244. doi: 10.1136/bmjopen-2014-007244. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C022901 | (1-6)-alpha-glucomannan |
| C000715207 | Amorphophallus konjac root extract |
| C008315 | maltodextrin |
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| Dietary Supplement |
|
| 0-24 weeks |
| 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 |
| 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 |
| Energy intake (kJ/d) | Based on self-written, 3-day food records | At baseline and at week 12, week 24. |
| Physical activity | Measured using an accelerometer | at baseline and at week 12 |
| Adverse events | 0-12 weeks |
| Blood pressure (systolic and diastolic) | The mean change from baseline to week 12, and week 24 | Baseline, week 12, 24 weeks. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |