Effects of Konjac Glucomannan Noodle Intervention in Subjects With Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glucomannan noodle
Placebo noodle
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria: Adults with metabolic syndrome
Subjects were considered to have metabolic syndrome if subjects had 3 of the following 5 characteristics:
- Abdominal obesity (waist circumference >= 90 cm in men and >= 80 cm in women)
- Impaired fasting glucose ( >= 5.6 mmol/L)
- Hypertriglyceridemia ( >= 1.7 mmol/L)
- Low HDL-C (< 1.0 mmol/L in men and < 1.3 mmol/L in women)
- Increased blood pressure (SBP >= 130 mmHg and DBP >= 85 mmHg).
Exclusion Criteria:
- Liver and renal diseases
- Undergoing statin therapy
- Pregnancy women
- Taking antioxidant vitamins supplements
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GMN Diet
PN Diet
Arm Description
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.
In the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan.
Outcomes
Primary Outcome Measures
Body Weight
Body weight by weighting scale (kilogram). Lower scores mean a better outcome in subjects.
Secondary Outcome Measures
Waist Circumference
Body waist by tape in centimeter
Glycemic Index
HbA1c (glycated hemoglobin) analysis
Lipid Index
LDL-C (low density lipoprotein cholesterol) analysis
Full Information
NCT ID
NCT02711306
First Posted
January 6, 2016
Last Updated
October 28, 2019
Sponsor
Taipei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02711306
Brief Title
Effects of Konjac Glucomannan Noodle Intervention in Subjects With Metabolic Syndrome
Official Title
Office of Human Research, Taipei Medical University
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GMN Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
PN Diet
Arm Type
Placebo Comparator
Arm Description
In the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan.
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucomannan noodle
Intervention Description
The participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo noodle
Intervention Description
In the placebo noodle diet, the participants received the same amount of noodles without glucomannan for 4 weeks.
Primary Outcome Measure Information:
Title
Body Weight
Description
Body weight by weighting scale (kilogram). Lower scores mean a better outcome in subjects.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Waist Circumference
Description
Body waist by tape in centimeter
Time Frame
4 weeks
Title
Glycemic Index
Description
HbA1c (glycated hemoglobin) analysis
Time Frame
4 weeks
Title
Lipid Index
Description
LDL-C (low density lipoprotein cholesterol) analysis
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults with metabolic syndrome
Subjects were considered to have metabolic syndrome if subjects had 3 of the following 5 characteristics:
Abdominal obesity (waist circumference >= 90 cm in men and >= 80 cm in women)
Impaired fasting glucose ( >= 5.6 mmol/L)
Hypertriglyceridemia ( >= 1.7 mmol/L)
Low HDL-C (< 1.0 mmol/L in men and < 1.3 mmol/L in women)
Increased blood pressure (SBP >= 130 mmHg and DBP >= 85 mmHg).
Exclusion Criteria:
Liver and renal diseases
Undergoing statin therapy
Pregnancy women
Taking antioxidant vitamins supplements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih-Han Lin, MS
Organizational Affiliation
Office of Human Research, Taipei Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18842808
Citation
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.
Results Reference
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Effects of Konjac Glucomannan Noodle Intervention in Subjects With Metabolic Syndrome
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