UMIN-CTR Clinical Trial

Public title

Effect of the Test Food on Voiding

Acronym

Effect of the Test Food on Voiding

Scientific Title

Effect of the Test Food on Voiding

Scientific Title:Acronym

Effect of the Test Food on Voiding

Region

Japan

Condition

N/A (healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to examine effect of the test food on voiding.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Voiding diary (From the first day of ingestion of a test material to the last day of the test)

Key secondary outcomes

*Secondary outcomes
[1]Indexes on sleeping (Pittsburgh Sleep Quality Index, OSA sleep inventory [Screening, Day 0 of observation Period I, Day 14 of Observation Period I, Day 0 of Observation Period II, Day 14 of Observation Period II).
[2]Indexes on physical condition (Japanese Translation of Profile of Mood States, SF-8 Acute version [Day 0 of Observation Period I, Day 14 of Observation Period I, Day 0 of Observation Period II, Day 14 of Observation Period II]).

*Safety
[1]Blood pressure, pulsation (Screening, Day 14 of Observation Period II)
[2]Weight, body fat percentage, BMI (Screening, Day 14 of Observation Period II)
[3]Doctor's questions (Screening, Day 14 of Observation Period II)
[4]Subject's diary(From the first day of ingestion of a test material to the last day of the test)

*Other indexes
[1]Hematologic test (Screening)
[2]Blood biochemical test (Screening)
[3]Urine analysis (Screening)
[4]Overactive Bladder Symptom Score (Screening)
[5]International Prostate Symptom Score ⁽¹⁾ (Screening)
[6]Simplified Menopausal Index ⁽²⁾ (Screening)
⁽¹⁾Only male subjects.
⁽²⁾Only female subjects.

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Oral intake of a test product (Observation Period I: 14days).
>Wash out period (14 days).
>Oral intake of a placebo product (Observation Period II: 14days).

Interventions/Control_2

Oral intake of a placebo product (Observation Period I: 14days).
>Wash out period (14 days).
>Oral intake of a test product (Observation Period II: 14days).

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

40

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

[1]Males and females aged 40-65 years.
[2]Individuals who are healthy and don't receive treatment.
[3]Individuals whose urinary frequencies in the daytime are 8-14 times and who wake up to urinate during asleep is less than 1 time.
[4]Individuals whose lights-out and weak-up time is regular, land time of sleeping is over 5 hours.
[5]Individuals whose written informed consent has been obtained.
[6]Individuals judged appropriate for the trial 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 who used a drug to treat a disease in the past 1 month.
[6]Individuals who have a history of heart failure, kidney failure, hepatitis B or hepatitis C.
[7]Individuals who have a history of digestive system disease.
[8]Individuals whose score of the Overactive Bladder Symptom Score in Question 3 is over 3 points and total points are over 2⁽¹⁾.
[9]Individuals whose score of the International Prostate Symptom Score is over 8 points ⁽¹⁾.
[10]Individuals whose score of the Simplified Menopausal Index is over 50 points ⁽²⁾.
[11]Individuals whose BMI is over 30.
[12]Individuals whose PSA level is over 4.0 ng/m ⁽¹⁾.
[13]Individuals who have a drinking habit.
[14]Individuals with serious anemia.
[15]Individuals who are sensitive to a test product or other foods, and medical products.
[16]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.
[17]Individuals with probable seasonal allergy, such as pollinosis, during the test period.
[18]Individuals whose life style will change during the test period.
[19]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[20]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[21]Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company.
[22]Individuals judged inappropriate for the study by the principal.
⁽¹⁾Only male subjects.
⁽²⁾Only female subjects.

Target sample size

28

Name of lead principal investigator

1st name
Middle name
Last name	Mitsuhiro Sugimoto

Organization

Otsubokai Medical Corporation Tohto Bunkyo Hospital

Division name

Head

Zip code

Address

3-5-7 Yushima Bunkyo-ku Tokyo 113-0034, JAPAN

TEL

+81-3-3831-2181

Email

info@tes-h.co.jp

Name of contact person

1st name
Middle name
Last name	Ryoma Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code

Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

+81-3-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

Asahi Group Holdings, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

06

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

05

Month

07

Day

Date of IRB

Anticipated trial start date

2018

Year

06

Month

09

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

06

Month

08

Day

Last modified on

2018

Year

12

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037214