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

Not Applicable

Completed

• Conditions: Type2 Diabetes Mellitus
• Interventions: Dietary Supplement: triticale and mung bean; Dietary Supplement: adzuki bean

• Registration Number: NCT02999867
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-12-07
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-21
• Study Start: 2017-03-01
• Primary Completion: 2017-04-15
• Study Completion: 2017-07-30
• Status Verified: 2017-08
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M1 triticale and mung bean	triticale and mung bean	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.
M2 adzuki bean	adzuki bean	M2: adzuki bean as a processed food is assigned to patients at a dose of 50-100 g/d for 30-day dietary intervention.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China