Effect of Triticale, Mung Bean and Adzuki Bean Intervention on Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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This study is designed to evaluate short term effect of triticale, mung bean and adzuki bean intervention for health improvement in patients with type 2 diabetes.

Detailed Description
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The study will evaluate the effect of triticale, mung bean and adzuki bean on metabolic and nutritional status of patients with type 2 diabetes after 30 days of intervention. Patients will be assigned to control or intervention group (A diet including triticale and mung bean; B diet including adzuki bean). Blood and urine samples will be collected at baseline and after 30 days of intervention.

Official Title
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Effect of Triticale, Mung Bean and Adzuki Bean Intervention on Metabolic and Nutritional Status of Patients With Type 2 Diabetes Mellitus

Conditions
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Type2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: triticale and mung bean
* Dietary Supplement: adzuki bean


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients between the ages of 30 and 65 years patients has been diagnosed as type 2 diabetes mellitus Patients who like to be followed up for 2 months. Exclusion Criteria: Women in pregnancy or lactation. Individuals with a history of severe kidney disease, cardiovascular disease, stroke, cancer, or psychological disorders.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M1 triticale and mung bean<br>M1: triticale and mung bean as a processed food is assigned to patients at a dose of 50-100 g/d for 30-day dietary intervention. | Dietary Supplement: triticale and mung bean<br>* subjects are assigned to intake of triticale and mung bean for 30 days<br>* Other names: M1 triticale and mung bean;|
| Experimental: M2 adzuki bean<br>M2: adzuki bean as a processed food is assigned to patients at a dose of 50-100 g/d for 30-day dietary intervention. | Dietary Supplement: adzuki bean<br>* subjects are assigned to intake of adzuki bean for 30 days<br>* Other names: M2 adzuki bean;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response to the dietary intervention by the change from baseline in blood glucose at 30-day |  | baseline and 30 d | 
| response to the dietary intervention by the change from baseline in lipid profile at 30-day |  | baseline and 30 d | 
| response to the dietary intervention by the change from baseline in insulin resistance at 30-day |  | baseline and 30 d | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response to the dietary intervention by the change from baseline in renal function at 30-day |  | baseline and 30 d | 
| response to the dietary intervention by the change from baseline in liver function at 30-day |  | baseline and 30 d | 
| response to the dietary intervention by the change from baseline in inflammation result at 30-day |  | baseline and 30 d | 
| response to the dietary intervention by the change from baseline in folic acid absorption at 30-day |  | baseline and 30 d | 
| response to the dietary intervention by the change from baseline in iron absorption at 30-day |  | baseline and 30 d |