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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041714
Receipt No. R000047152
Scientific Title The Effect of the Test Food for Urinary Function, Quality of Sleep and Quality of Life.
Date of disclosure of the study information 2021/10/05
Last modified on 2021/10/05

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Basic information
Public title The Effect of the Test Food for Urinary Function, Quality of Sleep and Quality of Life.
Acronym The Effect of the Test Food for Urinary Function, Quality of Sleep and Quality of Life.
Scientific Title The Effect of the Test Food for Urinary Function, Quality of Sleep and Quality of Life.
Scientific Title:Acronym The Effect of the Test Food for Urinary Function, Quality of Sleep and Quality of Life.
Region
Japan

Condition
Condition N/A (healthy adults)
Classification by specialty
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, quality of sleep and quality of life.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]Indexes for urination (Overactive Bladder-questionnaire (1), Nocturia-Quality of Life (1), urinary survey (2)).
(1): Screening, Week 0, Week 4, Week 8.
(2): Everyday From the seven days before the first day of ingestion of a test material to the last day of the test.
Key secondary outcomes *Secondary indexes
[1]Indexes for sleeping (The Japanese version of the Pittsburgh Sleep Quality Index(1), OSA sleep inventory MA version (2)).
[2]Indexes for QOL(SF-8TM standard version (1)).
(1): Screening, Week 0, Week 4, Week 8.
(2): Screening, Week 0 (for 5 days), Week 4 (for 5 days), Week 8 (for 5 days).

*Safety indexes
[1]Blood pressure, pulsation (1).
[2]Weight, body fat percentage, BMI (1).
[3]Blood test(1).
[4]Blood biochemical test(1).
[5]Urine analysis(1).
[6]Doctor's questions (1).
(1): Screening, Week 0, Week 8.

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 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Oral intake of Test Food A (3 capsules in a day; 8 weeks).
Interventions/Control_2 Oral intake of Test Food B (3 capsules in a day; 8 weeks).
Interventions/Control_3 Oral intake of the placebo (3 capsules in a day; 8 weeks).
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
70 years-old >
Gender Male
Key inclusion criteria [1]Japanese males aged 40-69 years.
[2]Individuals who are healthy and have no chronic physical disease.
[3]Individuals whose urinary frequencies in the daytime are 8-14 times and who wake up more than 5 days in a week to urinate after sleeping and before waking up.
[4]Individuals who are aware of mild sleep disorders such as a nocturnal awakening, an early morning awakening and a deep sleep disorder.
[5]Individuals who work on daytime from Monday to Friday and have Saturdays and Sundays off.
[6]Individuals whose lights-out and wake-up time is regular, and who have a habit of sleeping more than 5 hours.
[7]Individuals who sleep alone.
[8]Individuals who do not have a habit of drinking.
[9]Individuals whose written informed consent has been obtained.
[10]Individuals judged appropriate for the study by the principal.
Key exclusion criteria [1]Individuals using medical products.
[2]Individuals who use a drug for treatment of disease.
[3]Individuals who are suspected patient of, a patient of, or had a history of sleep apnea syndrome.
[4]Individuals who have or are suspected patient of nocturia, benign prostatic hyperplasia, overactive bladder.
[5]Individuals whose OABSS score is over 2 point in the Q. 3 and over 3 points in the total score of the OABSS, and OABSS score is over 6 points.
[6]Individuals whose IPSS score is over 8 points.
[7]Individuals who used a drug to treat a disease in the past 1 month.
[8]Individuals who have a history of heart failure, kidney failure, hepatitis B or hepatitis C.
[9]Individuals who have a history of digestive system disease.
[10]Individuals whose BMI is over 30kg/m2.
[11]Individuals who cannot stop drinking.
[12]Individuals who are sensitive to a test product or other foods, and medical products.
[13]Individuals who have a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
[14]Individuals with probable seasonal allergy, such as pollinosis, during the test period.
[15]Individuals whose life style will change during the test period.
[16]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[17]Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company.
[18]Individuals judged inappropriate for the study by the principal.
Target sample size 69

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Ono
Organization Ueno-Asagao Clinic
Division name Head
Zip code 110-0015
Address 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL +81-3-6240-1162
Email info@ueno-asagao.clinc

Public contact
Name of contact person
1st name Ryoma
Middle name
Last name Shimizu
Organization TES Holdings Co., Ltd.
Division name Administrative Department of Clinical Trials
Zip code 110-0015
Address 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL +81-3-6801-8480
Homepage URL
Email r.shimizu@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization Kobayashi Pharmaceutical 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
Email i.takahashi@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
2021 Year 10 Month 05 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 Completed
Date of protocol fixation
2020 Year 07 Month 28 Day
Date of IRB
2020 Year 07 Month 29 Day
Anticipated trial start date
2020 Year 10 Month 05 Day
Last follow-up date
2020 Year 12 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 07 Day
Last modified on
2021 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047152

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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