NCT02711306

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

October 29, 2019

Completed
Last Updated

October 29, 2019

Status Verified

March 1, 2013

Enrollment Period

8 months

First QC Date

January 6, 2016

Results QC Date

January 11, 2018

Last Update Submit

October 28, 2019

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Body Weight

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

    4 weeks

Secondary Outcomes (3)

  • Waist Circumference

    4 weeks

  • Glycemic Index

    4 weeks

  • Lipid Index

    4 weeks

Study Arms (2)

GMN Diet

EXPERIMENTAL

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.

Dietary Supplement: Glucomannan noodleDietary Supplement: Placebo noodle

PN Diet

PLACEBO COMPARATOR

In the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan.

Dietary Supplement: Glucomannan noodleDietary Supplement: Placebo noodle

Interventions

Glucomannan noodleDIETARY_SUPPLEMENT

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

GMN DietPN Diet
Placebo noodleDIETARY_SUPPLEMENT

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

GMN DietPN Diet

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Liver and renal diseases
  • Undergoing statin therapy
  • Pregnancy women
  • Taking antioxidant vitamins supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 18842808BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr. Sing-Chung Li
Organization
Taipei Medical University
sinchung@tmu.edu.tw
886-2-27361661

Study Officials

  • Chih-Han Lin, MS

    Office of Human Research, Taipei Medical University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2016

First Posted

March 17, 2016

Study Start

May 1, 2013

Primary Completion

January 1, 2014

Study Completion

March 1, 2014

Last Updated

October 29, 2019

Results First Posted

October 29, 2019

Record last verified: 2013-03

Data Sharing

IPD Sharing
Will not share