UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000041714
Receipt number	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 09:26:12

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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

N/A (healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

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-8^TM 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

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

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 or person

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047152