Effect of Konjac-mannan in Individuals With Insulin-Resistance Syndrome

November 13, 2018 updated by: Unity Health Toronto

Beneficial Effects of Viscous Dietary Fiber From Konjac-Mannan in Subjects With the Insulin Resistance Syndrome

To study whether a diet high in fiber from Konjac-mannan (KJM) has an effect on metabolic control in individuals with insulin resistance syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Impaired glucose tolerant
  • Clinical absent of CHD
  • BMI less than 30 kg/m2
  • Presence of full insulin resistance syndrome
  • Reduced HDL cholesterol
  • Elevated serum triglycerides
  • Moderate hypertension

Exclusion Criteria:

  • Regular smoking
  • Regular alcohol consumption
  • Family history of premature coronary heart disease
  • Hypothyroidism
  • Renal, hepatic or gastrointestinal disease
  • Taking medications for hyperglycemia
  • Taking medications for hyperlipidemia
  • Taking medications for hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Konjac-mannan
Konjac-mannan fiber-enriched biscuits with NCEP Step II metabolically controlled diet.
Dietary supplement: konjac glucomannan
Konjac-mannan fiber-enriched biscuits (0.5 g/412KJ [100kcal] of glucommanan)
Placebo Comparator: Placebo
wheat bran fiber biscuits with NCEP Step II metabolically controlled diet.
Dietary supplement: wheat bran
Wheat bran (hard red wheat bran) fiber enriched biscuits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in total:HDL cholesterol
Time Frame: change from baseline after 3 weeks, relative to control
change from baseline after 3 weeks, relative to control
change in fructosamine
Time Frame: change from baseline after 3 weeks, relative to control
change from baseline after 3 weeks, relative to control
change in systolic blood pressure
Time Frame: change from baseline after 3 weeks, relative to control
change from baseline after 3 weeks, relative to control

Secondary Outcome Measures

Outcome Measure
Time Frame
change in total cholesterol
Time Frame: change from baseline after 3 weeks, relative to control
change from baseline after 3 weeks, relative to control
change in LDL cholesterol
Time Frame: change from baseline after 3 weeks, relative to control
change from baseline after 3 weeks, relative to control
change in HDL cholesterol
Time Frame: change from baseline after 3 weeks, relative to control
change from baseline after 3 weeks, relative to control
change in apolipoprotein A-1
Time Frame: change from baseline after 3 weeks, relative to control
change from baseline after 3 weeks, relative to control
change in apolipoprotain B
Time Frame: change from baseline after 3 weeks, relative to control
change from baseline after 3 weeks, relative to control
change in glucose
Time Frame: change from baseline after 3 weeks, relative to control
change from baseline after 3 weeks, relative to control
change in insulin
Time Frame: change from baseline after 3 weeks, relative to control
change from baseline after 3 weeks, relative to control
change in diastolic blood pressure
Time Frame: change from baseline after 3 weeks, relative to control
change from baseline after 3 weeks, relative to control
change in body weight
Time Frame: change from baseline after 3 weeks, relative to control
change from baseline after 3 weeks, relative to control
change in apoB:ApoA-1
Time Frame: change from baseline after 3 weeks, relative to control
change from baseline after 3 weeks, relative to control

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Collaborators

Dicofarm
University of Toronto, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1991

Primary Completion (Actual)

June 1, 1992

Study Completion (Actual)

June 1, 1999

Study Registration Dates

First Submitted

November 7, 2018

First Submitted That Met QC Criteria

November 13, 2018

First Posted (Actual)

November 15, 2018

Study Record Updates

Last Update Posted (Actual)

November 15, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Konjac in Insulin Resistance

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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