Effects of Konjac Glucomannan Noodle Intervention in Subjects With Metabolic Syndrome

NCT ID: NCT02711306

Last Updated: 2019-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-03-31

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Glucomannan noodle

Intervention Type: DIETARY_SUPPLEMENT

The participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks.

Placebo noodle

Intervention Type: DIETARY_SUPPLEMENT

In the placebo noodle diet, the participants received the same amount of noodles without glucomannan for 4 weeks.

PN Diet

In the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan.

Group Type: PLACEBO_COMPARATOR

Glucomannan noodle

Intervention Type: DIETARY_SUPPLEMENT

The participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks.

Placebo noodle

Intervention Type: DIETARY_SUPPLEMENT

In the placebo noodle diet, the participants received the same amount of noodles without glucomannan for 4 weeks.

Interventions

Glucomannan noodle

The participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Placebo noodle

In the placebo noodle diet, the participants received the same amount of noodles without glucomannan for 4 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chih-Han Lin, MS

Role: PRINCIPAL_INVESTIGATOR

Office of Human Research, Taipei Medical University

References

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.

Reference Type: BACKGROUND

PMID: 18842808 (View on PubMed)

Other Identifiers

201209019

Identifier Type: -

Identifier Source: org_study_id