Effects of Konjac Glucomannan Noodle Intervention in Subjects With Metabolic Syndrome

Office of Human Research, Taipei Medical University

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Glucomannan noodle; Dietary supplement: Placebo noodle

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: January 6, 2016
• First Submitted That Met QC Criteria: March 13, 2016
• First Posted (Estimate): March 17, 2016

Study Record Updates

• Last Update Posted (Actual): October 29, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome; Gastrointestinal Agents; Cathartics; (1-6)-alpha-glucomannan
• Other Study ID Numbers: 201209019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No