Effects of Konjac Glucomannan Noodle Intervention in Subjects With Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Glucomannan noodle; Dietary Supplement: Placebo noodle

• Registration Number: NCT02711306
• Lead Sponsor: Taipei Medical University

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.

Study Timeline

• Status Verified: 2013-03
• Study Start: 2013-05
• Primary Completion: 2014-01
• Study Completion: 2014-03
• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-03-13
• Study First Posted: 2016-03-17
• Results First Submitted: 2018-01-11
• Results First Submitted QC: 2019-10-28
• Last Update Submitted: 2019-10-28
• Results First Posted: 2019-10-29
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GMN Diet	Placebo noodle	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.
PN Diet	Glucomannan noodle	In the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan.
GMN Diet	Glucomannan noodle	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.
PN Diet	Placebo noodle	In the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan.

Primary Outcome Measures

Name	Time	Method
Body Weight	4 weeks	Body weight by weighting scale (kilogram). Lower scores mean a better outcome in subjects.

Secondary Outcome Measures

Name	Time	Method
Waist Circumference	4 weeks	Body waist by tape in centimeter
Glycemic Index	4 weeks	HbA1c (glycated hemoglobin) analysis
Lipid Index	4 weeks	LDL-C (low density lipoprotein cholesterol) analysis