UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054477 |
|---|---|
| Receipt number | R000062224 |
| Scientific Title | Examination of the Effect of Nutritional Guidance Using Cooking studio on the Eating Behavior of Diabetic Patients |
| Date of disclosure of the study information | 2024/05/25 |
| Last modified on | 2024/12/27 16:43:24 |
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Basic information
Public title
Examination of the Effect of Nutritional Guidance Using Cooking studio on the Eating Behavior of Diabetic Patients
Acronym
cooking studio and food variety
Scientific Title
Examination of the Effect of Nutritional Guidance Using Cooking studio on the Eating Behavior of Diabetic Patients
Scientific Title:Acronym
cooking studio and food variety
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We focused on side dishes (such as kinpira gobo (fried burdock root), hijiki stew, spinach and tuna salad, etc.) because it is easy to prepare a well-balanced meal with a main dish, two side dishes and rice. We will provide outpatients with nutritional guidance plus cooking guidance (6 kinds of side dishes) in the cooking studio at a later date, and ask them to cook them at home in the same way to see if the dietary diversity improves and the dietary fiber intake increases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We clarify whether nutritional guidance + cooking studio improve food diversity scores (calculated from FFQg) for 4weeks.
Key secondary outcomes
We clarify whether nutritional guidance + cooking studio improve dietary fiber intake, energy and other nutrients intake, body size, HbA1c, and Eating Behavior Questionnaire Score.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
We provide guidance on cooking side dishes (6 types) in the Healthy Kitchen and have the students cook the same at home.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. patients who, after receiving full explanation and with full understanding, give written consent of their own free will to participate in this study
2. patients who are at least 20 years old and less than 75 years old at the time of obtaining consent
3. patients diagnosed with type 2 diabetes mellitus based on the diagnostic criteria of diabetes mellitus
4. patients with no change in treatment (type of medication) from the first nutritional guidance to the second nutritional guidance (change of insulin units is allowed).
Key exclusion criteria
1. patients with severe diabetic complications (renal failure stage, severe proliferative retinopathy) or dementia
2. other patients who are deemed inappropriate by the principal investigator or research coordinator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsumi |
| Middle name | |
| Last name | Iizuka |
Organization
Fujita health university
Division name
The department of clinical nutrition, graduate school of medicine
Zip code
470-1192
Address
1, 98, Dengakugakubo, KUtsukakecho, Toyoake, Aichi, Japan
TEL
0562-93-2329
kastumi.iizuka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | katsumi |
| Middle name | |
| Last name | Iizuka |
Organization
Fujita health university
Division name
Department of clinical medicine, Graduate school of medicine
Zip code
470-1192
Address
1, 98, Dengakugakubo, KUtsukakecho, Toyoake, Aichi, Japan
TEL
0562-93-2329
Homepage URL
katsumi.iizuka@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita health university
Institute
Department
Personal name
Katsumi Iizuka
Funding Source
Organization
Fujita health university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita health university
Address
1-98, dengakugakubo, kutsukakemachi, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
HM23-469
Org. issuing International ID_1
Fujita health university
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
藤田医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 24 | Day |
Last modified on
| 2024 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062224
