Office of Human Research, Taipei Medical University
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metabolic Syndrome
- Sponsor
- Taipei Medical University
- Enrollment
- 36
- Primary Endpoint
- Body Weight
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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. 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Body Weight
Time Frame: 4 weeks
Body weight by weighting scale (kilogram). Lower scores mean a better outcome in subjects.
Secondary Outcomes
- Waist Circumference(4 weeks)
- Glycemic Index(4 weeks)
- Lipid Index(4 weeks)