Effects of Konjac Glucomannan Noodle Intervention in Subjects With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Office of Human Research, Taipei Medical University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711306
• Other study ID #: 201209019
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: March 2014

Study information

• Verified date: March 2013
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Glucomannan noodle
The participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks.
• Placebo noodle
In the placebo noodle diet, the participants received the same amount of noodles without glucomannan for 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight	Body weight by weighting scale (kilogram). Lower scores mean a better outcome in subjects.	4 weeks
Secondary	Waist Circumference	Body waist by tape in centimeter	4 weeks
Secondary	Glycemic Index	HbA1c (glycated hemoglobin) analysis	4 weeks
Secondary	Lipid Index	LDL-C (low density lipoprotein cholesterol) analysis	4 weeks