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

Primary Purpose

Type2 Diabetes, Coronary Heart Disease

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

konjac glucomannan

wheat bran

About this trial

This is an interventional treatment trial for Type2 Diabetes focused on measuring konjac, type2 diabetes, fiber, coronary heart disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Konjac-mannan

Placebo

Arm Description

Konjac-mannan fiber-enriched biscuits with NCEP Step II metabolically controlled diet

wheat bran fiber biscuits with NCEP Step II metabolically controlled diet

Outcomes

Primary Outcome Measures

change in total:HDL cholesterol

change in fructosamine

change in systolic blood pressure

Secondary Outcome Measures

change in total cholesterol

change in LDL cholesterol

change in HDL cholesterol

change in apolipoprotein A-1

change in apolipoprotain B

change in glucose

change in insulin

diastolic blood pressure

change in body weight

change in apoB:ApoA-1

Full Information

NCT ID

NCT03741660

First Posted

November 7, 2018

Last Updated

November 13, 2018

Sponsor

Unity Health Toronto

Collaborators

Dicofarm, University of Toronto

1. Study Identification

Unique Protocol Identification Number

NCT03741660

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

January 1991 (Actual)

Primary Completion Date

June 1992 (Actual)

Study Completion Date

June 1998 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Unity Health Toronto

Collaborators

Dicofarm, University of Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type2 Diabetes, Coronary Heart Disease

Keywords

konjac, type2 diabetes, fiber, coronary heart disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Konjac-mannan

Arm Type

Experimental

Arm Description

Konjac-mannan fiber-enriched biscuits with NCEP Step II metabolically controlled diet

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

wheat bran fiber biscuits with NCEP Step II metabolically controlled diet

Intervention Type

Dietary Supplement

Intervention Name(s)

konjac glucomannan

Intervention Description

Konjac-mannan fiber-enriched biscuits (0.7 g/412KJ [100kcal] of glucommanan)

Intervention Type

Dietary Supplement

Intervention Name(s)

wheat bran

Intervention Description

Wheat bran (hard red wheat bran) fiber enriched biscuits

Primary Outcome Measure Information:

Title

change in total:HDL cholesterol

Time Frame