Metabolic SyndromeNCT02711306
Effects of Konjac Glucomannan Noodle Intervention in Subjects With Metabolic Syndrome
A study testing Glucomannan noodle in people with Metabolic Syndrome, run by Taipei Medical University.
Trial summary
Metabolic syndrome (MS) is a complex disease with a cluster of risk factors and clinical features, which includes central or abdominal obesity, atherogenic dyslipidemia, impaired glucose regulation, hyperinsulinemia, high blood pressure, and concomitance of pro-inflammatory cytokine and insulin resistance. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Glucomannan noodle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects were considered to have metabolic syndrome if subjects had 3 of the following 5 characteristics:
- Abdominal obesity (waist circumference >= 90 cm in men and >= 80 cm in women)
- Impaired fasting glucose ( >= 5.6 mmol/L)
- Hypertriglyceridemia ( >= 1.7 mmol/L)
- Low HDL-C (< 1.0 mmol/L in men and < 1.3 mmol/L in women)
- Increased blood pressure (SBP >= 130 mmHg and DBP >= 85 mmHg).
Who cannot join
- Liver and renal diseases
- Undergoing statin therapy
- Pregnancy women
- Taking antioxidant vitamins supplements
About this study
Official title: Office of Human Research, Taipei Medical University
Metabolic syndrome (MS) is a complex disease with a cluster of risk factors and clinical features, which includes central or abdominal obesity, atherogenic dyslipidemia, impaired glucose regulation, hyperinsulinemia, high blood pressure, and concomitance of pro-inflammatory cytokine and insulin resistance. Glucomannan (GM) is a water-soluble dietary fiber derived from the root of Amorphophallus konjac that can improve blood sugar, blood fat concentration, and weight management, and has other health benefits.The purposes of this study are going to investigate the effects of KGM noodle (KGN) as stable food to MS and diabetic patients.
Read the detailed description
The KGN diet was composed of well-cooked noodle with 2 g of KGM in a dosage of 200 g/piece twice daily to substitute the daily carbohydrate for 4 weeks, with a 2-week washout period between alternative diets. All 33 subjects received two servings of either GMNs or PNs (400 g) per day, which replaced the main carbohydrate in two daily meals for 4 weeks. After a 2-week washout period, the subjects received the other type of noodle for 4 weeks. The body weight, BMI, waist circumference, fasting blood glucose and lipid profile, as well as serum vitamin A, E, β-carotene and high sensitivity C-reactive protein (hs-CPR) were measured by HPCL.
- Conditions
- Metabolic Syndrome
- Being tested
- Glucomannan noodle, Placebo noodle
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucomannan noodleDietary supplement
The participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks.
Placebo noodleDietary supplement
In the placebo noodle diet, the participants received the same amount of noodles without glucomannan for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| GMN Diet | Experimental | In the glucomannan noodle (GMN) diet, the participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks, with each serving of glucomannan noodles weighing up to 200 g with 2 g of glucomannan. Receives: Dietary Supplement: Glucomannan noodle; Dietary Supplement: Placebo noodle |
| PN Diet | Placebo comparator | In the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan. Receives: Dietary Supplement: Glucomannan noodle; Dietary Supplement: Placebo noodle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Body weight by weighting scale (kilogram). Lower scores mean a better outcome in subjects.
Measured: 4 weeks
Secondary outcomes (3)
Waist Circumference
Body waist by tape in centimeter
Measured: 4 weeks
Glycemic Index
HbA1c (glycated hemoglobin) analysis
Measured: 4 weeks
Lipid Index
LDL-C (low density lipoprotein cholesterol) analysis
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMay 2013
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chih-Han Lin, MS, Principal investigator, Office of Human Research, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711306
- Sponsor's protocol ID
- 201209019
- Status last verified
- Mar 2013
- First submitted
- 6 Jan 2016
- Last updated
- 29 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sood N, Baker WL, Coleman CI. Effect of glucomannan on plasma lipid and glucose concentrations, body weight, and blood pressure: systematic review and meta-analysis. Am J Clin Nutr. 2008 Oct;88(4):1167-75. doi: 10.1093/ajcn/88.4.1167.
PubMed 18842808
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Office of Human Research, Taipei Medical University
- ClinicalTrials.gov ID
- NCT02711306
- Acronym / sponsor ID
- 201209019
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Posted 29 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metabolic syndrome (MS) is a complex disease with a cluster of risk factors and clinical features, which includes central or abdominal obesity, atherogenic dyslipidemia, impaired glucose regulation, hyperinsulinemia, high blood pressure, and concomitance of pro-inflammatory cytokine and insulin resistance. Glucomannan (GM) is a water-soluble dietary fiber derived from the root of Amorphophallus konjac that can improve blood sugar, blood fat concentration, and weight management, and has other health benefits.The purposes of this study are going to investigate the effects of KGM noodle (KGN) as stable food to MS and diabetic patients.
Detailed description
The KGN diet was composed of well-cooked noodle with 2 g of KGM in a dosage of 200 g/piece twice daily to substitute the daily carbohydrate for 4 weeks, with a 2-week washout period between alternative diets. All 33 subjects received two servings of either GMNs or PNs (400 g) per day, which replaced the main carbohydrate in two daily meals for 4 weeks. After a 2-week washout period, the subjects received the other type of noodle for 4 weeks. The body weight, BMI, waist circumference, fasting blood glucose and lipid profile, as well as serum vitamin A, E, β-carotene and high sensitivity C-reactive protein (hs-CPR) were measured by HPCL.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GMN Diet | Experimental | Dietary Supplement: Glucomannan noodle, Dietary Supplement: Placebo noodleIn the glucomannan noodle (GMN) diet, the participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks, with each serving of glucomannan noodles weighing up to 200 g with 2 g of glucomannan. |
| PN Diet | Placebo comparator | Dietary Supplement: Glucomannan noodle, Dietary Supplement: Placebo noodleIn the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects were considered to have metabolic syndrome if subjects had 3 of the following 5 characteristics:
- Abdominal obesity (waist circumference >= 90 cm in men and >= 80 cm in women)
- Impaired fasting glucose ( >= 5.6 mmol/L)
- Hypertriglyceridemia ( >= 1.7 mmol/L)
- Low HDL-C (< 1.0 mmol/L in men and < 1.3 mmol/L in women)
Key exclusion criteria (4 listed)
- Liver and renal diseases
- Undergoing statin therapy
- Pregnancy women
- Taking antioxidant vitamins supplements
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 |
|---|---|---|
| Glucomannan noodleThe participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks. | Dietary supplement | GMN Diet, PN Diet |
| Placebo noodleIn the placebo noodle diet, the participants received the same amount of noodles without glucomannan for 4 weeks. | Dietary supplement | GMN Diet, PN Diet |
Primary outcome
Body Weight
Time frame: 4 weeks
Body weight by weighting scale (kilogram). Lower scores mean a better outcome in subjects.
3 secondary outcomes
Waist Circumference
Time frame: 4 weeks
Glycemic Index
Time frame: 4 weeks
Lipid Index
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18842808Sood N, Baker WL, Coleman CI. Effect of glucomannan on plasma lipid and glucose concentrations, body weight, and blood pressure: systematic review and meta-analysis. Am J Clin Nutr. 2008 Oct;88(4):1167-75. doi: 10.1093/ajcn/88.4.1167.
- Individual participant dataSharing planned: No
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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.
Chih-Han Lin, MS principal investigator
Office of Human Research, Taipei Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Glucomannan noodle in people with Metabolic Syndrome, run by Taipei Medical University.
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 6 inclusion and 4 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 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Body Weight (time frame: 4 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 NCT02711306, which also lists 1 linked publication.
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 29 Oct 2019.