Back to resultsEffect of Konjac-mannan in Individuals With Insulin-Resistance Syndrome
Primary Purpose
Insulin Resistance Syndrome
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 Insulin Resistance Syndrome focused on measuring insulin resistance syndrome, fiber, konjac
Eligibility Criteria
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
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
change in diastolic blood pressure
change in body weight
change in apoB:ApoA-1
Full Information
NCT ID
NCT03741686
First Posted
November 7, 2018
Last Updated
November 13, 2018
Sponsor
Unity Health Toronto
Collaborators
Dicofarm, University of Toronto, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03741686
Brief Title
Effect of Konjac-mannan in Individuals With Insulin-Resistance Syndrome
Official Title
Beneficial Effects of Viscous Dietary Fiber From Konjac-Mannan in Subjects With the Insulin Resistance Syndrome
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 1999 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
Dicofarm, University of Toronto, 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 study whether a diet high in fiber from Konjac-mannan (KJM) has an effect on metabolic control in individuals with insulin resistance syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance Syndrome
Keywords
insulin resistance syndrome, fiber, konjac
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 (0.5 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 after 3 weeks, relative to control
Title
change in fructosamine
Time Frame
change from baseline after 3 weeks, relative to control
Title
change in systolic blood pressure
Time Frame
change from baseline after 3 weeks, relative to control
Secondary Outcome Measure Information:
Title
change in total cholesterol
Time Frame
change from baseline after 3 weeks, relative to control
Title
change in LDL cholesterol
Time Frame
change from baseline after 3 weeks, relative to control
Title
change in HDL cholesterol
Time Frame
change from baseline after 3 weeks, relative to control
Title
change in apolipoprotein A-1
Time Frame
change from baseline after 3 weeks, relative to control
Title
change in apolipoprotain B
Time Frame
change from baseline after 3 weeks, relative to control
Title
change in glucose
Time Frame
change from baseline after 3 weeks, relative to control
Title
change in insulin
Time Frame
change from baseline after 3 weeks, relative to control
Title
change in diastolic blood pressure
Time Frame
change from baseline after 3 weeks, relative to control
Title
change in body weight
Time Frame
change from baseline after 3 weeks, relative to control
Title
change in apoB:ApoA-1
Time Frame
change from baseline after 3 weeks, relative to control
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Effect of Konjac-mannan in Individuals With Insulin-Resistance Syndrome
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