UMIN-CTR Clinical Trial

Public title

Effect of the Test Food on Stress, Fatigue, Sleeping and Voiding.

Acronym

Effect of the Test Food on Stress, Fatigue, Sleeping and Voiding.

Scientific Title

Effect of the Test Food on Stress, Fatigue, Sleeping and Voiding.

Scientific Title:Acronym

Effect of the Test Food on Stress, Fatigue, Sleeping and 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 stress, fatigue, sleeping and voiding.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Indexes on stress and fatigue and indexes on sleeping (Japanese Translation of Profile of Mood States, VAS and Pittsburgh Sleep Quality Index [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]).

Key secondary outcomes

*Secondary outcomes
[1]Indexes on physical condition (King's HealthQuestionnaire [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]Voiding diary (From the first day of ingestion of a test material to the last day of the test).

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

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

Food

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 10-14 times and who wake up to urinate during asleep is more than 3 time/weeks.
[4]Individuals who have poor sleep quality, stress and fatigue because they wake up in the midnight (nocturnal awakening), wake up early in the morning (early morning awakening), do not feel well asleep (impaired sleep disorder).
[5]Individuals whose lights-out and weak-up time is regular, land time of sleeping is over 5 hours.
[6]Individuals who have no habit of taking alcohol.
[7]Individuals who can measure and record urination volume during the observation period
[8]Individuals whose written informed consent has been obtained.
[9]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 who can not prohibit alcohol intake during the observation period.
[13]Individuals who are sensitive to a test product or other foods, and medical products.
[14]Individuals who have a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 1 months or will ingest those foods during the test period.
[15]Individuals with probable seasonal allergy, such as pollinosis, during the test period.
[16]Individuals whose life style will change during the test period.
[17]Individuals who are pregnant, nursing or possibly pregnant.
[18]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[19]Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company.
[20]Individuals judged inappropriate for the study by the principal.
⁽¹⁾Only male subjects.
⁽²⁾Only female subjects.

Target sample size

24

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

Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, JAPAN

TEL

03-6240-1162

Email

info@ueno-asagao.clinic

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

Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, 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 Quality & Innovations, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ueno-Asagao Clinic Ethical Review Committee

Address

Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015 JAPAN

Tel

+81-3-6240-1162

Email

jimukyoku@tes-h.co.jp

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

2019

Year

05

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

24

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

2019

Year

03

Month

11

Day

Date of IRB

2019

Year

03

Month

18

Day

Anticipated trial start date

2019

Year

05

Month

09

Day

Last follow-up date

2019

Year

06

Month

29

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

04

Month

11

Day

Last modified on

2019

Year

09

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041354