Konjac-Mannan Improves Glycemia and Other Risk Factors for CHD in T2DM
Overview
To examine whether Konjac-mannan fiber improves metabolic control measured by glycemia, lipidemia, and blood pressure in individuals with type-2 diabetes.
Full Title of Study: “Konjac-Mannan (Glucomannan) Improves Glycemia and Other Associated Risk Factors for Coronary Heart Disease in Type 2 Diabetes”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: June 1992
Interventions
- Dietary Supplement: konjac glucomannan
- Konjac-mannan fiber-enriched biscuits (0.7 g/412KJ [100kcal] of glucommanan)
- Dietary Supplement: wheat bran
- Wheat bran (hard red wheat bran) fiber enriched biscuits
Arms, Groups and Cohorts
- Experimental: Konjac-mannan
- Konjac-mannan fiber-enriched biscuits with NCEP Step II metabolically controlled diet
- Placebo Comparator: Placebo
- wheat bran fiber biscuits with NCEP Step II metabolically controlled diet
Clinical Trial Outcome Measures
Primary Measures
- change in total:HDL cholesterol
- Time Frame: change from baseline at week 3, relative to control
- change in fructosamine
- Time Frame: 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
Secondary Measures
- change in total cholesterol
- Time Frame: 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 in HDL cholesterol
- Time Frame: 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 in apolipoprotain B
- Time Frame: change from baseline at week 3, relative to control
- change in glucose
- Time Frame: change from baseline at week 3, relative to control
- change in insulin
- Time Frame: change from baseline at week 3, relative to control
- diastolic blood pressure
- Time Frame: 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 in apoB:ApoA-1
- Time Frame: change from baseline at week 3, relative to control
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Unity Health Toronto
- Collaborator
- Dicofarm
- Provider of Information About this Clinical Study
- Sponsor
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