Konjac-Mannan Improves Glycemia and Other Risk Factors for CHD in T2DM

November 13, 2018 updated by: Unity Health Toronto

Konjac-Mannan (Glucomannan) Improves Glycemia and Other Associated Risk Factors for Coronary Heart Disease in Type 2 Diabetes

To examine whether Konjac-mannan fiber improves metabolic control measured by glycemia, lipidemia, and blood pressure in individuals with type-2 diabetes.

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hyperlipidemia controlled by medication
  • hypertension controlled by medication
  • type 2 diabetes controlled by medication
  • minimum 3 years since onset of all three conditions
  • sedentary lifestyle

Exclusion Criteria:

  • regular smoking
  • regular alcohol consumption
  • family history of premature coronary heart disease
  • hypothyroidism
  • renal, hepatic or gastrointestinal disease

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 (0.7 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 at week 3, relative to control
change from baseline at week 3, relative to control
change in fructosamine
Time Frame: change from baseline at week 3, relative to control
change from baseline at week 3, relative to control
change in systolic blood pressure
Time Frame: change from baseline at week 3, relative to control
change from baseline at week 3, relative to control

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Unity Health Toronto

Collaborators

University of Toronto
Dicofarm

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, 1998

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 T2DM

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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