Back to resultsEffect of Triticale, Mung Bean and Adzuki Bean Intervention on Patients With Type 2 Diabetes
Primary Purpose
Type2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
triticale and mung bean
adzuki bean
Sponsored by
About this trial
This is an interventional supportive care trial for Type2 Diabetes Mellitus
Eligibility Criteria
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.
Sites / Locations
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
M1 triticale and mung bean
M2 adzuki bean
Arm Description
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 as a processed food is assigned to patients at a dose of 50-100 g/d for 30-day dietary intervention.
Outcomes
Primary Outcome Measures
response to the dietary intervention by the change from baseline in blood glucose at 30-day
response to the dietary intervention by the change from baseline in lipid profile at 30-day
response to the dietary intervention by the change from baseline in insulin resistance at 30-day
Secondary Outcome Measures
response to the dietary intervention by the change from baseline in renal function at 30-day
response to the dietary intervention by the change from baseline in liver function at 30-day
response to the dietary intervention by the change from baseline in inflammation result at 30-day
response to the dietary intervention by the change from baseline in folic acid absorption at 30-day
response to the dietary intervention by the change from baseline in iron absorption at 30-day
Full Information
NCT ID
NCT02999867
First Posted
December 7, 2016
Last Updated
September 4, 2018
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02999867
Brief Title
Effect of Triticale, Mung Bean and Adzuki Bean Intervention on Patients With Type 2 Diabetes
Official Title
Effect of Triticale, Mung Bean and Adzuki Bean Intervention on Metabolic and Nutritional Status of Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
April 15, 2017 (Actual)
Study Completion Date
July 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes Mellitus
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
M1 triticale and mung bean
Arm Type
Experimental
Arm Description
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.
Arm Title
M2 adzuki bean
Arm Type
Experimental
Arm Description
M2: adzuki bean as a processed food is assigned to patients at a dose of 50-100 g/d for 30-day dietary intervention.
Intervention Type
Dietary Supplement
Intervention Name(s)
triticale and mung bean
Other Intervention Name(s)
M1 triticale and mung bean
Intervention Description
subjects are assigned to intake of triticale and mung bean for 30 days
Intervention Type
Dietary Supplement
Intervention Name(s)
adzuki bean
Other Intervention Name(s)
M2 adzuki bean
Intervention Description
subjects are assigned to intake of adzuki bean for 30 days
Primary Outcome Measure Information:
Title
response to the dietary intervention by the change from baseline in blood glucose at 30-day
Time Frame
baseline and 30 d
Title
response to the dietary intervention by the change from baseline in lipid profile at 30-day
Time Frame
baseline and 30 d
Title
response to the dietary intervention by the change from baseline in insulin resistance at 30-day
Time Frame
baseline and 30 d
Secondary Outcome Measure Information:
Title
response to the dietary intervention by the change from baseline in renal function at 30-day
Time Frame
baseline and 30 d
Title
response to the dietary intervention by the change from baseline in liver function at 30-day
Time Frame
baseline and 30 d
Title
response to the dietary intervention by the change from baseline in inflammation result at 30-day
Time Frame
baseline and 30 d
Title
response to the dietary intervention by the change from baseline in folic acid absorption at 30-day
Time Frame
baseline and 30 d
Title
response to the dietary intervention by the change from baseline in iron absorption at 30-day
Time Frame
baseline and 30 d
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanping Liu, master
Organizational Affiliation
Department of Nutrition, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Triticale, Mung Bean and Adzuki Bean Intervention on Patients With Type 2 Diabetes
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