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Effects of Konjac Glucomannan Noodle Intervention in Subjects With Metabolic Syndrome

T

Taipei Medical University

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Dietary Supplement: Glucomannan noodle
Dietary Supplement: Placebo noodle

Study type

Interventional

Funder types

Other

Identifiers

NCT02711306
201209019

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

20 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

36 participants in 2 patient groups, including a placebo group

GMN Diet
Experimental group
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.
Treatment:
Dietary Supplement: Glucomannan noodle
Dietary Supplement: Placebo noodle
PN Diet
Placebo Comparator group
Description:
In the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan.
Treatment:
Dietary Supplement: Glucomannan noodle
Dietary Supplement: Placebo noodle

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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