ObesityPhase 4NCT02280772
Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children
A Phase 4 study testing Glucomannan and Maltodextrin in people with Obesity and Overweight, run by Medical University of Warsaw at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Glucomannan and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 sitePoland
- Study dates
- 27 Apr 2015to 28 Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
The Medical University of Warsaw, Department of Paediatrics
Warsaw, Masovian Voivodeship, 02-091
About this study
Official title: Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Obesity, Overweight
- Being tested
- Glucomannan, Maltodextrin
- Keywords
- glucomannan, obesity, children, overweight, adolescents, treatment
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucomannanDietary supplement
Also called Amorphophallus konjac
MaltodextrinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Glucomannan | Experimental | Glucomannan orally, 3g/day (in three divided doses), for 12 weeks Receives: Dietary Supplement: Glucomannan |
| Maltodextrin | Placebo comparator | Maltodextrin orally, 3g/day (in three divided doses), for 12 weeks Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI-for-age z-score difference
Baseline versus end of the intervention
Measured: 0-12 weeks
Secondary outcomes (8)
Body composition
Whole body fat, central body fat, fat-free mass (grams) assessed by a dual energy X-ray absorption (DXA)
Measured: 0-13 weeks
BMI-for-age z-score difference
Baseline versus end of the follow-up
Measured: 0-24 weeks
Proportion of participants with dyslipidemia
Proportion of participants with dyslipidemia from baseline to week 12 and week 24 (mean change, SD)
Measured: 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).
Measured: At baseline, 12 weeks and 24 weeks
Energy intake (kJ/d)
Based on self-written, 3-day food records
Measured: At baseline and at week 12, week 24.
Physical activity
Measured using an accelerometer
Measured: at baseline and at week 12
Adverse events
Measured: 0-12 weeks
Blood pressure (systolic and diastolic)
The mean change from baseline to week 12, and week 24
Measured: Baseline, week 12, 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study start27 Apr 2015
- Primary completion2 Jan 2018
- Study completion28 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bartlomiej M Zalewski, MD, Principal investigator, The Medical University of WarsawHanna Szajewska, Professor, Study chair, The Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280772
- Sponsor's protocol ID
- 07-2014
- Status last verified
- Oct 2017
- First submitted
- 29 Oct 2014
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31036412Zalewski 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.
PubMed 25869689
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02280772
- Acronym / sponsor ID
- 07-2014
- Conditions
- Obesity, Overweight
- Keywords
- glucomannan, obesity, children, overweight, adolescents, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 27 Apr 2015 (actual)
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 28 Mar 2018 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucomannan | Experimental | Dietary Supplement: GlucomannanGlucomannan orally, 3g/day (in three divided doses), for 12 weeks |
| Maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin orally, 3g/day (in three divided doses), for 12 weeks |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucomannanAlso: Amorphophallus konjac | Dietary supplement | Glucomannan |
| Maltodextrin | Dietary supplement | Maltodextrin |
Primary outcome
BMI-for-age z-score difference
Time frame: 0-12 weeks
Baseline versus end of the intervention
8 secondary outcomes
Body composition
Time frame: 0-13 weeks
BMI-for-age z-score difference
Time frame: 0-24 weeks
Proportion of participants with dyslipidemia
Time frame: At baseline, 12 weeks and 24 weeks
Proportion of participants with impaired fasting plasma glucose (FPG)
Time frame: At baseline, 12 weeks and 24 weeks
Energy intake (kJ/d)
Time frame: At baseline and at week 12, week 24.
Physical activity
Time frame: at baseline and at week 12
Adverse events
Time frame: 0-12 weeks
Blood pressure (systolic and diastolic)
Time frame: Baseline, week 12, 24 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Derived from this study: PubMed 31036412Zalewski 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.
- Derived from this study: PubMed 25869689Zalewski 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bartlomiej M Zalewski, MD principal investigator
The Medical University of Warsaw
Hanna Szajewska, Professor study chair
The Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucomannan and Maltodextrin in people with Obesity and Overweight, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI-for-age z-score difference (time frame: 0-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02280772, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.