Metabolic Syndrome
Conditions
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.
Interventions
DIETARY_SUPPLEMENTGlucomannan noodle
The participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks.
DIETARY_SUPPLEMENTPlacebo noodle
In the placebo noodle diet, the participants received the same amount of noodles without glucomannan for 4 weeks.
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
Adults with metabolic syndrome Subjects were considered to have metabolic syndrome if subjects had 3 of the following 5 characteristics: 1. Abdominal obesity (waist circumference \>= 90 cm in men and \>= 80 cm in women) 2. Impaired fasting glucose ( \>= 5.6 mmol/L) 3. Hypertriglyceridemia ( \>= 1.7 mmol/L) 4. Low HDL-C (\< 1.0 mmol/L in men and \< 1.3 mmol/L in women) 5. Increased blood pressure (SBP \>= 130 mmHg and DBP \>= 85 mmHg).
Exclusion criteria
1. Liver and renal diseases 2. Undergoing statin therapy 3. Pregnancy women 4. Taking antioxidant vitamins supplements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | 4 weeks | Body weight by weighting scale (kilogram). Lower scores mean a better outcome in subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Index | 4 weeks | HbA1c (glycated hemoglobin) analysis |
| Lipid Index | 4 weeks | LDL-C (low density lipoprotein cholesterol) analysis |
| Waist Circumference | 4 weeks | Body waist by tape in centimeter |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| First GMN Then PN First Intervention (4 weeks, GMN), Washout (2 weeks) and Second Intervention (4 weeks, PN) | 16 |
| First PN Then GMN First Intervention (4 weeks, PN), Washout (2 weeks) and Second Intervention (4 weeks, GMN) | 16 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | First GMN Then PN | First PN Then GMN | Total |
|---|---|---|---|
| Age, Continuous | 57.75 years STANDARD_DEVIATION 4.96 | 49.82 years STANDARD_DEVIATION 12.59 | 50.79 years STANDARD_DEVIATION 10.78 |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Body Weight
Body weight by weighting scale (kilogram). Lower scores mean a better outcome in subjects.
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GMN Diet | Body Weight | Baseline | 75.2 kg | Standard Deviation 10.86 |
| GMN Diet | Body Weight | End | 74.41 kg | Standard Deviation 10.49 |
| PN Diet | Body Weight | Baseline | 74.97 kg | Standard Deviation 11.44 |
| PN Diet | Body Weight | End | 74.39 kg | Standard Deviation 11.27 |
Secondary
Glycemic Index
HbA1c (glycated hemoglobin) analysis
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GMN Diet | Glycemic Index | Baseline | 7.28 percentage | Standard Deviation 1.65 |
| GMN Diet | Glycemic Index | End | 7.08 percentage | Standard Deviation 1.54 |
| PN Diet | Glycemic Index | Baseline | 7.21 percentage | Standard Deviation 1.69 |
| PN Diet | Glycemic Index | End | 7.12 percentage | Standard Deviation 1.6 |
Secondary
Lipid Index
LDL-C (low density lipoprotein cholesterol) analysis
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GMN Diet | Lipid Index | Baseline | 133.86 mg/dL | Standard Deviation 32.54 |
| GMN Diet | Lipid Index | End | 137.24 mg/dL | Standard Deviation 33.99 |
| PN Diet | Lipid Index | Baseline | 135.39 mg/dL | Standard Deviation 28.02 |
| PN Diet | Lipid Index | End | 130.53 mg/dL | Standard Deviation 33.63 |
Secondary
Waist Circumference
Body waist by tape in centimeter
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GMN Diet | Waist Circumference | Baseline | 92.03 cm | Standard Deviation 6.69 |
| GMN Diet | Waist Circumference | End | 90.17 cm | Standard Deviation 6.8 |
| PN Diet | Waist Circumference | Baseline | 91.14 cm | Standard Deviation 7.26 |
| PN Diet | Waist Circumference | End | 90.15 cm | Standard Deviation 7.11 |