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
Sponsored by
About this trial
This is an interventional treatment trial for Type2 Diabetes focused on measuring konjac, type2 diabetes, fiber, coronary heart disease
Eligibility Criteria
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
change from baseline at week 3, relative to control
Title
change in fructosamine
Time Frame
change from baseline at week 3, relative to control
Title
change in systolic blood pressure
Time Frame
change from baseline at week 3, relative to control
Secondary Outcome Measure Information:
Title
change in total cholesterol
Time Frame
change from baseline at week 3, relative to control
Title
change in LDL cholesterol
Time Frame
change from baseline at week 3, relative to control
Title
change in HDL cholesterol
Time Frame
change from baseline at week 3, relative to control
Title
change in apolipoprotein A-1
Time Frame
change from baseline at week 3, relative to control
Title
change in apolipoprotain B
Time Frame
change from baseline at week 3, relative to control
Title
change in glucose
Time Frame
change from baseline at week 3, relative to control
Title
change in insulin
Time Frame
change from baseline at week 3, relative to control
Title
diastolic blood pressure
Time Frame
change from baseline at week 3, relative to control
Title
change in body weight
Time Frame
change from baseline at week 3, relative to control
Title
change in apoB:ApoA-1
Time Frame
change from baseline at week 3, relative to control
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Konjac-Mannan Improves Glycemia and Other Risk Factors for CHD in T2DM
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