UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036476 |
|---|---|
| Receipt number | R000041354 |
| Scientific Title | Effect of the Test Food on Stress, Fatigue, Sleeping and Voiding. |
| Date of disclosure of the study information | 2019/05/08 |
| Last modified on | 2019/09/17 16:46:21 |
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Basic information
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
Condition
N/A (healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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).
Base
Study type
Interventional
Study design
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
Intervention
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
Eligibility
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
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
Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, JAPAN
TEL
03-6240-1162
info@ueno-asagao.clinic
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
Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, 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
Kairaku Building 6F, 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
| 2019 | Year | 05 | Month | 08 | 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
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
Progress
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
Other related information
Management 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
