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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| PN Diet | Placebo Comparator | In the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucomannan noodle | Dietary Supplement | The participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Body weight by weighting scale (kilogram). Lower scores mean a better outcome in subjects. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Waist Circumference | Body waist by tape in centimeter | 4 weeks |
| Glycemic Index | HbA1c (glycated hemoglobin) analysis | 4 weeks |
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Inclusion Criteria: Adults with metabolic syndrome
Subjects were considered to have metabolic syndrome if subjects had 3 of the following 5 characteristics:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chih-Han Lin, MS | Office of Human Research, Taipei Medical University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18842808 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | First GMN Then PN | "First Intervention (4 weeks, GMN)", "Washout (2 weeks)" and "Second Intervention (4 weeks, PN)" |
| FG001 | First PN Then GMN | "First Intervention (4 weeks, PN)", "Washout (2 weeks)" and "Second Intervention (4 weeks, GMN)" |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | First GMN Then PN | "First Intervention (4 weeks, GMN)", "Washout (2 weeks)" and "Second Intervention (4 weeks, PN)" |
| BG001 | First PN Then GMN | "First Intervention (4 weeks, PN)", "Washout (2 weeks)" and "Second Intervention (4 weeks, GMN)" |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Weight | Body weight by weighting scale (kilogram). Lower scores mean a better outcome in subjects. | Posted | Mean | Standard Deviation | kg | 4 weeks |
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The adverse event data were collected from the participants during intervention and assessed after 6 months.
Adverse events were reported in real time, as they occurred (if any) by a physician who saw the subjects each day. As this was a dietary analysis/no pharmacological intervention, no adverse events were expected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GMN Diet | The 100 g GMN noodle contains 1 g of konjac glucomannan powder. Participants approximately consumed 2 g GMN per day in 200 g of noodle. The intervention period was 4 weeks long. Meanwhile, the participants remained their usual eating habits except consuming any probiotics or prebiotics. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sing-Chung Li | Taipei Medical University | 886-2-27361661 | 6560 | sinchung@tmu.edu.tw |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Placebo noodle | Dietary Supplement | In the placebo noodle diet, the participants received the same amount of noodles without glucomannan for 4 weeks. |
|
| Lipid Index | LDL-C (low density lipoprotein cholesterol) analysis | 4 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Waist Circumference | Body waist by tape in centimeter | Posted | Mean | Standard Deviation | cm | 4 weeks |
|
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| Secondary | Glycemic Index | HbA1c (glycated hemoglobin) analysis | Posted | Mean | Standard Deviation | percentage | 4 weeks |
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| Secondary | Lipid Index | LDL-C (low density lipoprotein cholesterol) analysis | Posted | Mean | Standard Deviation | mg/dL | 4 weeks |
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| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | PN Diet | Isocaloric noodle with no konjac glucomannan powder in placebo comparator. The PN-participants daily consumed placebo noodle without any added GMN (approximately 200 g noodle per day). The intervention period was 4 weeks long. Meanwhile, the participants will remain their usual eating habits except consuming any probiotics or prebiotics. | 0 | 32 | 0 | 32 | 0 | 32 |
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| D009750 |
| Nutritional and Metabolic Diseases |