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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
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

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

    First Posted
    January 6, 2016
    Last Updated
    October 28, 2019
    Sponsor
    Taipei Medical University
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    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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