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OpenTrials
Completed

NCT Number: NCT02711306

Effects of Konjac Glucomannan Noodle Intervention in Subjects With Metabolic Syndrome

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.

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Key information

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucomannan noodle

Dietary Supplement

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

Placebo noodle

Dietary Supplement

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

Primary outcomes

  1. Body Weight

    Time frame: 4 weeks

    Body weight by weighting scale (kilogram). Lower scores mean a better outcome in subjects.

Secondary outcomes

  1. Waist Circumference

    Time frame: 4 weeks

    Body waist by tape in centimeter

  2. Glycemic Index

    Time frame: 4 weeks

    HbA1c (glycated hemoglobin) analysis

  3. Lipid Index

    Time frame: 4 weeks

    LDL-C (low density lipoprotein cholesterol) analysis

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

Office of Human Research, Taipei Medical University

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 17, 2016
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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