UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053881 |
|---|---|
| Receipt number | R000061456 |
| Scientific Title | Dietary Intervention Study for Adult Asthma patients |
| Date of disclosure of the study information | 2024/03/17 |
| Last modified on | 2024/03/17 21:33:00 |
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Basic information
Public title
Dietary Intervention Study for Adult Asthma patients
Acronym
OIKEN for Asthma
Scientific Title
Dietary Intervention Study for Adult Asthma patients
Scientific Title:Acronym
DISA
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the impact of dietary interventions similar to those used in lifestyle diseases on the quality of life of adult asthmatics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in AQLQ (asthma-related quality of life) from baseline after 4 weeks of dietary intervention
Key secondary outcomes
Changes in weight and body composition assessment from the baseline to 4 weeks and 8 weeks, and the following questionnaire.
- Self-assessment of compliance with dietary intervention
- Dietary survey including frequency of consumption of fermented foods, etc.
- Symptom of asthma (ACQ-5)
- Symptom of gastroesophageal reflux symptoms (FSSG)
- Symptom of depression and anxiety (HADS)
Questionnaire of the following items from the baseline to 4 weeks and 8 weeks.
- Nutritional Questionnaire prepared by the National Institute of Biomedical Innovation, National Institute of Health and Nutrition (questionnaire used for analysis of intestinal bacteria)
- Questionnaire prepared by the National Institute of Biomedical Innovation and Nutrition (questionnaire used for analysis of intestinal flora)
The following laboratory data at the baseline, 4 weeks, and 8 weeks.
- Blood samples: counting the number of white and red blood cells, TARC, airbone antigen-specific IgE, total IgE
- LDL-C, HDL-C, lipoprotein, triglycerides, HbA1c, insulin, C-peptide, uric acid, zinc
- Pulmonary function tests: spirometry, mostograph
- Exhaled nitric oxide concentration (FeNO)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
The program will provide guidance on diet and nutritional guidance for lifestyle diseases using "Oishi Kenko", a menu creation support app from Oishii Kenko.
In addition to the use of this app, a dietitian will check the daily diet for the first four weeks. During the following four weeks, the frequency will be reduced to twice a week.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have been diagnosed with bronchial asthma in the past, are able to visit Keio University Hospital, and meet at least one of the following criteria
- Obesity with a BMI of 25 or higher
- Type 2 diabetes with HbA1c less than 8%.
- Dyslipidemia
- Hyperuricemia
Key exclusion criteria
- Pregnant or lactating mothers
- Chronic kidney disease Grade 3a or higher or renal failure with eGFR less than 59 ml/min/1.73m2
- Type 1 diabetes or diabetes on insulin or type 2 diabetes with HbA1c more than or equal to 8%.
- Patients with hypertension deemed poorly controlled by the clinician
- Other conditions for which the clinician determines that the diet recommended in this study may be associated with an exacerbation of the underlying disease.
- Those who cannot give consent to participate in the study.
- Those who have difficulty using the contents of Oishi Kenko app.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Katsunori |
| Middle name | |
| Last name | Masaki |
Organization
Keio University School of Medicine
Division name
Division of Pulmonary Medicine, Department of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
masakik@keio.jp
Public contact
Name of contact person
| 1st name | Katsunori |
| Middle name | |
| Last name | Masaki |
Organization
Keio University School of Medicine
Division name
Division of Pulmonary Medicine, Department of Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
masakik@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Oishi kenko Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | 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 | 03 | Month | 17 | Day |
Last modified on
| 2024 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061456
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| Registered date | File name |
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