UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055549 |
|---|---|
| Receipt number | R000063452 |
| Scientific Title | Effects of daily consumption of dried powdered asparagus on the reduction of eye and nasal discomfort for 8 weeks: A randomized, double-blind, placebo-controlled parallel-group comparison study |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/05/13 15:17:53 |
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Basic information
Public title
Effects of daily consumption of dried powdered asparagus on the reduction of eye and nasal discomfort for 8 weeks: A randomized, double-blind, placebo-controlled parallel-group comparison study
Acronym
Clinical trial to investigate the reduction effects of nasal and eye discomfort by dried powdered asparagus
Scientific Title
Effects of daily consumption of dried powdered asparagus on the reduction of eye and nasal discomfort for 8 weeks: A randomized, double-blind, placebo-controlled parallel-group comparison study
Scientific Title:Acronym
Clinical trial to investigate the reduction effects of nasal and eye discomfort by dried powdered asparagus
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of daily consumption of dried powdered asparagus on the reduction of eye and nasal discomfort in healthy subjects who regularly have nasal and eye discomfort but are not receiving any drug treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the total score of nasal and ocular symptoms on the Japanese Standard Quality of Life Questionnaire for Allergic Rhinitis (JRQLQ) No. 1 before and after ingestion of dried powdered asparagus or placebo food for 8 weeks.
Key secondary outcomes
1. The actual value and the change of total score of nasal and ocular symptoms on the JRQLQ No. 1 before and after ingestion of dried powdered asparagus or placebo food for 8 weeks (Other than primary endpoint).
2. The actual value and the change of scores for each of nasal and ocular six symptoms on the JRQLQ No. 1 before and after ingestion of dried powdered asparagus or placebo food for 8 weeks.
3. The actual value and the change of total QOL score, scores for each of the six domain(daily living, outdoor activities, social life, sleep, physical, and mental life) on the JRQLQ No. 1 before and after ingestion of dried powdered asparagus or placebo food for 8 weeks.
4. The actual value and the change of overall state score on the JRQLQ No. 1 before and after ingestion of dried powdered asparagus or placebo food for 8 weeks.
5. The actual value and the change of nonspecific and specific IgE levels before and after ingestion of dried powdered asparagus or placebo food for 8 weeks.
6. The actual value and the change of Pperipheral blood eosinophils count before and after ingestion of dried powdered asparagus or placebo food for 8 weeks.
7. The actual value and the change of metabolic syndrome related index (BMI, body weight, glucose, HbA1c, LDL-cholesterol, HDL-cholesterol, and triglyceride) before and after ingestion of dried powdered asparagus or placebo food for 8 weeks.
8. The actual value and the change of scores for each of the eight domains and two summary scores on SF-8 before and after ingestion of dried powdered asparagus or placebo food for 8 weeks.
9. Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The subjects take dried powdered asparagus 10g per day for 8 weeks.
Interventions/Control_2
The subjects take placebo food 10g per day for 8 weeks.
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects who are judged as healthy by self-reported health questionnaire.
2. Subjects who have regular nasal or ocular discomfort (responded with any of the symptoms in "I. Nasal and Ocular Symptoms" on the JRQLQ No. 1) and who do not regularly use medicines for symptom relief.
3. Subjects who have no clinical abnormality by screening tests.
4. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
1.Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular, dermatological, and/or mental disease, or who have history of those disease.
2.Subjects who have a serious injury or surgical history within 12weeks prior to this study.
3.Pre-or post-menopausal women having obvious changes in physical condition.
4. Subjects who unable to ingest asparagus.
5.Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction.
6. Heavy smokers (more than 21 cigarettes per day), alcohol addicts (more than 80g per day alcohol), subjects who are alcohol or drug dependence, subjects who are suspected of alcohol or drug dependence.
7.Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study.
8.Subjects donate either 400ml or 200ml whole blood or blood component within four weeks prior to this study or subjects who plan to donate blood during this study.
9. Subjects who are pregnant or lactating, or subjects who expect to be pregnant during this study.
10.Subjects who have cognitive disorder or who have possibility of the disorder.
11.Subjects who participate and take the study drug in other clinical trials within four weeks prior to this study.
12.Subjects who are judges as unsuitable for this study by the principal investigator or subinvestigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuji |
| Middle name | |
| Last name | Arimura |
Organization
University of Miyazaki
Division name
Department of Health Care Research, Organization for Promotion of Research and Industry-Academic Regional Collaboration, University of Miyazaki (Kiyotake Branch)
Zip code
8891692
Address
Kihara5200, Kiyotake, Miyazaki889-1692, Japan
TEL
0985859577
yasuji_arimura@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuji |
| Middle name | |
| Last name | Arimura |
Organization
University of Miyazaki
Division name
Department of Health Care Research, University of Miyazaki (Kiyotake Branch)
Zip code
8891692
Address
Kihara5200, Kiyotake, Miyazaki889-1692, Japan
TEL
0985859577
Homepage URL
yasuji_arimura@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Saga Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Industrial Technology Center of Saga
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of University of Miyazaki
Address
Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
Tel
0985859010
igakubu_kenkyu@med.miyazaki-u.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 | 10 | Month | 01 | 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 | 08 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 13 | Day |
Date trial data considered complete
| 2025 | Year | 05 | Month | 13 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063452
