Effect of Triticale, Mung Bean and Adzuki Bean Intervention on Patients With Type 2 Diabetes
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2016
CompletedFirst Posted
Study publicly available on registry
December 21, 2016
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2017
CompletedSeptember 6, 2018
August 1, 2017
2 months
December 7, 2016
September 4, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (5)
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
Study Arms (2)
M1 triticale and mung bean
EXPERIMENTALM1: 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
EXPERIMENTALM2: adzuki bean as a processed food is assigned to patients at a dose of 50-100 g/d for 30-day dietary intervention.
Interventions
subjects are assigned to intake of triticale and mung bean for 30 days
subjects are assigned to intake of adzuki bean for 30 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Women in pregnancy or lactation.
- Individuals with a history of severe kidney disease, cardiovascular disease, stroke, cancer, or psychological disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Yanping Liu, master
Department of Nutrition, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2016
First Posted
December 21, 2016
Study Start
March 1, 2017
Primary Completion
April 15, 2017
Study Completion
July 30, 2017
Last Updated
September 6, 2018
Record last verified: 2017-08