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

Type2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02999867
• Other study ID #: PUMCH-ZS-1048
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: July 30, 2017

Study information

• Verified date: August 2017
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 30, 2017
• Est. primary completion date: April 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male and female patients between the ages of 30 and 65 years

2. patients has been diagnosed as type 2 diabetes mellitus

3. Patients who like to be followed up for 2 months.

Exclusion Criteria:

1. Women in pregnancy or lactation.

2. Individuals with a history of severe kidney disease, cardiovascular disease, stroke, cancer, or psychological disorders.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Intervention

Dietary Supplement:
• triticale and mung bean
subjects are assigned to intake of triticale and mung bean for 30 days
• adzuki bean
subjects are assigned to intake of adzuki bean for 30 days

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response to the dietary intervention by the change from baseline in blood glucose at 30-day		baseline and 30 d
Primary	response to the dietary intervention by the change from baseline in lipid profile at 30-day		baseline and 30 d
Primary	response to the dietary intervention by the change from baseline in insulin resistance at 30-day		baseline and 30 d
Secondary	response to the dietary intervention by the change from baseline in renal function at 30-day		baseline and 30 d
Secondary	response to the dietary intervention by the change from baseline in liver function at 30-day		baseline and 30 d
Secondary	response to the dietary intervention by the change from baseline in inflammation result at 30-day		baseline and 30 d
Secondary	response to the dietary intervention by the change from baseline in folic acid absorption at 30-day		baseline and 30 d
Secondary	response to the dietary intervention by the change from baseline in iron absorption at 30-day		baseline and 30 d