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

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

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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: triticale and mung bean; Dietary supplement: adzuki bean

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: M1 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.	Dietary supplement: triticale and mung bean; subjects are assigned to intake of triticale and mung bean for 30 days; Other Names: M1 triticale and mung bean
Experimental: M2 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.	Dietary supplement: adzuki bean; subjects are assigned to intake of adzuki bean for 30 days; Other Names: M2 adzuki bean

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Yanping Liu, master, Department of Nutrition, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): April 15, 2017
• Study Completion (Actual): July 30, 2017

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (Estimate): December 21, 2016

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 4, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PUMCH-ZS-1048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No