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

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

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

Conditions
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Type2 Diabetes, Coronary Heart Disease

Intervention / Treatment
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* Dietary Supplement: konjac glucomannan
* Dietary Supplement: wheat bran


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Konjac-mannan<br>Konjac-mannan fiber-enriched biscuits with NCEP Step II metabolically controlled diet | Dietary Supplement: konjac glucomannan<br>* Konjac-mannan fiber-enriched biscuits (0.7 g/412KJ [100kcal] of glucommanan)<br>|
| Placebo Comparator: Placebo<br>wheat bran fiber biscuits with NCEP Step II metabolically controlled diet | Dietary Supplement: wheat bran<br>* Wheat bran (hard red wheat bran) fiber enriched biscuits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in total:HDL cholesterol |  | change from baseline at week 3, relative to control | 
| change in fructosamine |  | change from baseline at week 3, relative to control | 
| change in systolic blood pressure |  | change from baseline at week 3, relative to control | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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konjac, type2 diabetes, fiber, coronary heart disease