Effects of Konjac Glucomannan Noodle Intervention in Subjects With Metabolic Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Office of Human Research, Taipei Medical University

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Glucomannan noodle
* Dietary Supplement: Placebo noodle


Participation Criteria
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Eligibility Criteria
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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: 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). Exclusion Criteria: Liver and renal diseases Undergoing statin therapy Pregnancy women Taking antioxidant vitamins supplements

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GMN Diet<br>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. | Dietary Supplement: Glucomannan noodle<br>* The participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks.<br>Dietary Supplement: Placebo noodle<br>* In the placebo noodle diet, the participants received the same amount of noodles without glucomannan for 4 weeks.<br>|
| Placebo Comparator: PN Diet<br>In the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan. | Dietary Supplement: Glucomannan noodle<br>* The participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks.<br>Dietary Supplement: Placebo noodle<br>* In the placebo noodle diet, the participants received the same amount of noodles without glucomannan for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight | Body weight by weighting scale (kilogram). Lower scores mean a better outcome in subjects. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist Circumference | Body waist by tape in centimeter | 4 weeks | 
| Glycemic Index | HbA1c (glycated hemoglobin) analysis | 4 weeks | 
| Lipid Index | LDL-C (low density lipoprotein cholesterol) analysis | 4 weeks |