Effect of Konjac-mannan in Individuals With Insulin-Resistance Syndrome

Study Overview
=================
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.

Official Title
-----------------
Beneficial Effects of Viscous Dietary Fiber From Konjac-Mannan in Subjects With the Insulin Resistance Syndrome

Conditions
-----------------
Insulin Resistance Syndrome

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


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 (0.5 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?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin resistance syndrome, fiber, konjac