UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054043 |
|---|---|
| Receipt number | R000059554 |
| Scientific Title | Dietary Intervention Study for Adult Asthmatics |
| Date of disclosure of the study information | 2024/05/30 |
| Last modified on | 2025/04/09 08:20:37 |
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Basic information
Public title
Dietary Intervention Study for Adult Asthmatics
Acronym
Asthma Diet Study
Scientific Title
Dietary Intervention Study for Adult Asthmatics
Scientific Title:Acronym
Asthma Diet Study
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the impact and mechanisms of lifestyle-based dietary interventions on asthma control in adult asthmatics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in AQLQ (Asthma Quality of Life Questionnaire) from baseline after 4 weeks of dietary intervention
Key secondary outcomes
Changes in weight and body composition assessment using InBody at the start of the dietary intervention (0 weeks), 4 weeks, and 8 weeks
The following questionnaire items at the start of dietary intervention (week 0), 2, 4, and 8 weeks
Self-assessment of compliance with nutritional guidance
Dietary survey including frequency of consumption of fermented foods, etc.
Asthma control (ACQ-5)
Asthma Quality of Life Questionnaire (AQLQ)
Gastroesophageal reflux symptoms (FSSG)
Depression and anxiety (HADS)
Questionnaire items of the following items at the start of the dietary intervention (week 0) and at week 8
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 bacteria)
The following laboratory indices at the start of the dietary intervention (week 0), at 4 weeks, and at 8 weeks:
Blood samples: (peripheral blood, fractionated), TARC, inhaled antigen-specific IgE, total IgE)
LDL-C, HDL-C, lipoprotein, triglycerides, HbA1c, insulin, C-peptide, uric acid, zinc
Respiratory function tests: spirometry-assessed lung air volume fraction, effort lung capacity
Respiratory function tests: respiratory resistance evaluated by spirometry, respiratory reactance
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
Self control
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
Patients will receive dietary intervention based on the specific suggestions of the dietitian for 4 weeks from the start of the intervention; the strict dietary intervention period.
Recipes supervised by a dietitian from Oishi-Kenko will be proposed to the patients based on nutritional guidance for obesity, diabetes, dyslipidemia, and hyperuricemia.
Patients are required to cook at least one meal (night meal is the best) a day by shopping based on the list of ingredients necessary for the proposed meal.
Patients are encouraged not to miss any meals for the remaining two meals, and to try to follow the diet based on the nutritional guidance through meetings with a dietitian (including online, SMS tools, etc.). This may include a photographic evaluation of prepared meals.
No snacking is to be done, and if snacking is done, it is to be kept to a minimum.
The two points, which are reported to have a positive effect on bronchial asthma, should be followed; taking tree nuts/soy products.
Send a daily evaluation of their ability to follow the suggested diet to the dietitian and receive feedback and guidance from the dietitian.
The diet during the period when the subjects are unable to adhere to the proposed diet because they are unable to shop or cook for themselves as suggested for some reason will be left up to the research subjects. This case will be treated as deficient; which is assumed to be approximately 30% of the 4-week period of the strict diet intervention period.
After the 4-week period, it is not mandatory to practice the eating behaviors proposed during the strict diet intervention period. However, patients will be encouraged to adhere to the eating behaviors in accordance with the guidelines for lifestyle-related diseases by using the app during the following 4 weeks (weeks 4-8 of the intervention), and feedback by the dietitian will continue at a reduced frequency of twice a week (tolerance period)
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
| 18 | 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 one of the following criteria
Obesity with a BMI of 25 or more
Type 2 diabetes with HbA1c less than 8%.
Dyslipidemia
Hyperuricemia
The above conditions do not require the applicant to be a patient at Keio University hospital. If the patient has an outpatient clinic, obtain verbal consent from the attending physician.
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 mellitus, type 2 diabetes mellitus on insulin, or type 2 diabetes mellitus with HbA1c of 8% or higher
Patients with hypertension that is judged to be poorly controlled by the clinician
Other conditions for which the clinician determines that the diet recommended in this study may be associated with exacerbation of the underlying disease
Those who cannot give their consent to participate in the study.
Those who have difficulty using the contents of the Oishii 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 ,Japan
TEL
+81333531211
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
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Jaoan
TEL
+81333531211
Homepage URL
masakik@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
Tel
+81333531211
masakik@keio.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 | 05 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2034 | Year | 12 | 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 | 04 | Month | 03 | Day |
Last modified on
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059554
