UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052848 |
|---|---|
| Receipt number | R000060246 |
| Scientific Title | Effect of the Test Food Intake on Urination. |
| Date of disclosure of the study information | 2023/11/20 |
| Last modified on | 2024/01/19 09:44:02 |
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Basic information
Public title
Effect of the Test Food Intake on Urination.
Acronym
Effect of the Test Food Intake on Urination.
Scientific Title
Effect of the Test Food Intake on Urination.
Scientific Title:Acronym
Effect of the Test Food Intake on Urination.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effect of the test food for urinary function and quality of life.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indexes for urination
Key secondary outcomes
* Secondary outcomes
1) Overactive Bladder-questionnaire (1)
2) King's Health Questionnaire (1)
* Safety
1) Blood pressure, pulsation (1)
2) Weight, body fat percentage, BMI (1)
3) Hematologic test (1)
4) Blood biochemical test (1)
5) Urine analysis (1)
6) Doctor's questions (1)
7) Subject's diary (2)
(1): Week 0, Week 8
(2): Recording all days from the designated day to the end of the test.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food (2 pills in a day; 8 weeks).
Interventions/Control_2
Oral intake of the placebo food (2 pills in a day; 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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged 40-64 years.
2) Individuals who are healthy and don't receive treatment.
3) Individuals whose urinary frequencies in the daytime are 8-10 times.
4) Individuals who wake up to urinate 0 to 1 times in a day from the time they go to bed at night to the time they wake up in the morning
5) Individuals whose written informed consent has been obtained.
6) Individuals judged appropriate for the trial by the principal.
Key exclusion criteria
1)Individuals who are currently suffering from some kind of disease and undergoing drug treatment. And individuals who regularly use pharmaceuticals or quasi-drugs for purposes other than disease treatment.
2)Individuals who are suffering from, are undergoing treatment for, or have a history of serious diseases such as diabetes, kidney disease, heart disease, thyroid disease, adrenal gland disease, or other metabolic diseases.
3)Individuals who have a history of heart failure, kidney failure, hepatitis B or hepatitis C.
4)Individuals who have a history of digestive system disease.
5)Individuals whose PSA level is over 4.0 ng/m.
6)Individuals with nocturia, benign prostatic hyperplasia, or overactive bladder.
7)Individuals who meet the following criteria on the Overactive Bladder Symptom Questionnaire:
I.Diagnostic criteria for overactive bladder
Individuals who have a urinary urgency score of 2 points or more, and an OABSS total score of 3 points or more and who may have overactive bladder.
II.Determination of severity of overactive bladder
Individuals with OABSS total score of 6 points or more.
8)Individuals who used a drug to treat a disease in the past 1 month.
9)Individuals whose BMI is over 30.
10)Individuals who are sensitive to a test product or other foods, and medical products.
11)Individuals who have a habit of continuously taking functional foods, health foods, or supplements that claim urinary-related indicators in the past month, or who plan to take them during the study period.
12)Individuals whose life style will change during the test period.
13)Individuals who are pregnant, nursing or possibly pregnant.
14)Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
15)Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company.
16)Individuals judged inappropriate for the study by the principal.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Shimizu |
Organization
Medical Corporation Seishukai Hasegawa Hospital
Division name
Head
Zip code
111-0036
Address
5-45-7 Higashinippori Arakawa-ku Tokyo 111-0036, JAPAN
TEL
+81-3-5830-5654
k-sudo@seishukai.or.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Sudo |
Organization
Medical Corporation Seishukai Hasegawa Hospital
Division name
Clinical trial office
Zip code
111-0036
Address
5-45-7 Higashi Nippori Arakawa-ku Tokyo 111-0036, JAPAN
TEL
+81-3-5830-5654
Homepage URL
k-sudo@seishukai.or.jp
Sponsor or person
Institute
Medical Corporation Seishukai Hasegawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Oryza Oil & Fat Chemical Co. Ltd
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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.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
| 2023 | Year | 11 | Month | 20 | 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
| 2023 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 20 | Day |
Last modified on
| 2024 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060246
