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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031493
Receipt No. R000035707
Scientific Title Effects of the Test Food for Sleep Quality and Sleepiness, Fatigue, Concentration, and Motivation.
Date of disclosure of the study information 2019/04/29
Last modified on 2019/09/17

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Basic information
Public title Effects of the Test Food for Sleep Quality and Sleepiness, Fatigue, Concentration, and Motivation.
Acronym Effects of the Test Food for Sleep Quality and Sleepiness, Fatigue, Concentration, and Motivation.
Scientific Title Effects of the Test Food for Sleep Quality and Sleepiness, Fatigue, Concentration, and Motivation.
Scientific Title:Acronym Effects of the Test Food for Sleep Quality and Sleepiness, Fatigue, Concentration, and Motivation.
Region
Japan

Condition
Condition N/A(healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study examines effects of the test food for sleep quality and sleepiness, fatigue, concentration, and motivation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]Electroencephalography measurement with SleepScope (Day 0, 5 days of the observation period I, 5 days of the observation period II, 5 days of the observation period III)
[2]OSA sleep inventory (Screening, Day 0, 5 days of the observation period I, 5 days of the observation period II, 5 days of the observation period III)
Key secondary outcomes *Secondary outcomes
[1]Epworth Sleepiness Scale (ESS) (Screening, Day 0, 5th day of the observation period I, 5th day of the observation period II, 5th day of the observation period III)
[2]Visual analogue scale for exhilarating feeling upon waking (Screening, Day 0, 5th day of the observation period I, 5th day of the observation period II, 5th day of the observation period III)
[3]Visual analogue scale for conditions in the daytime (Screening, Day 0, 5th day of the observation period I, 5th day of the observation period II, 5th day of the observation period III)

*Safety
[1]Blood pressure (Screening, Day 0, 5th day of the observation period I, 5th day of the observation period II, 5th day of the observation period III)
[2]Weight, body fat percentage, BMI (Day 0, 5th day of the observation period I, 5th day of the observation period II, 5th day of the observation period III)
[3]Doctor's questions (Day 0, 5th day of the observation period I, 5th day of the observation period II, 5th day of the observation period III)
[4]Subject's diary (From the first day of ingestion of a test material to the last day of the test)

*Other indexes
[1]Blood test (Screening)
[2]Blood biochemical test (Screening)
[3]Urine analysis (Screening)
[4]Pittsburgh Sleep Quality Index (PSQI-J) (Screening)

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 6
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Observation Period I: Oral intake of the test food A (5 days)
>Washout period (1 week)
>Observation Period II: Oral intake of the test food B (5 days)
>Washout period (1 week)
>Observation Period III: Oral intake of the placebo food (5 days)
Interventions/Control_2 Observation Period I: Oral intake of the test food A (5 days)
>Washout period (1 week)
>Observation Period II: Oral intake of the placebo food (5 days)
>Washout period (1 week)
>Observation Period III: Oral intake of the test food B (5 days)
Interventions/Control_3 Observation Period I: Oral intake of the test food B (5 days)
>Washout period (1 week)
>Observation Period II: Oral intake of the test food A (5 days)
>Washout period (1 week)
>Observation Period III: Oral intake of the placebo food (5 days)
Interventions/Control_4 Observation Period I: Oral intake of the test food B (5 days)
>Washout period (1 week)
>Observation Period II: Oral intake of the placebo food (5 days)
>Washout period (1 week)
>Observation Period III: Oral intake of the test food A (5 days)
Interventions/Control_5 Observation Period I: Oral intake of the placebo food (5 days)
>Washout period (1 week)
>Observation Period II: Oral intake of the test food A (5 days)
>Washout period (1 week)
>Observation Period III: Oral intake of the test food B (5 days)
Interventions/Control_6 Observation Period I: Oral intake of the placebo food (5 days)
>Washout period (1 week)
>Observation Period II: Oral intake of the test food B (5 days)
>Washout period (1 week)
>Observation Period III: Oral intake of the test food A (5 days)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria [1]Males aged 20-64 years of postmenopausal females aged 20-64 years.
[2]Individuals who are healthy and don't receive treatment.
[3]Individuals who fell fatigued, are bad falling asleep, or sleep badly.
[4]Individuals whose Pittsburgh Sleep Quality Index (PSQI-J) score is over 6 points.
[5]Individuals whose lights-out and weak-up time is regular, light-out time is before 0 AM, and time of sleeping is over 4 hours.
[6]Individuals who sleep alone.
[7]Individuals who work on daytime from Monday to Friday and have Saturdays and Sundays off.
[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 BMI is over 30.
[9]Individuals whose systolic and diastolic blood pressures are over 140mmHg and 90mmHg, respectively.
[10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
[11]Individuals who cannot restrict to taking coffee and tea less than 2 cups in a day.
[12]Individuals who are a smoker.
[13]Individuals with serious anemia.
[14]Individuals who are sensitive to a test product or other foods, and medical products.
[15]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, energy drinks, or supplements in the past 1 month or will ingest those foods during the test period.
[16]Individuals with probable seasonal allergy, such as pollinosis, during the test period.
[17]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[18]Individuals whose sleep situation will be different according to circumstances like sleepover.
[19]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[20]Individuals who participated in other clinical studies in the past 3 months.
[21]Individuals who are sensitive to the electrode pad.
[22]Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company.
[23]Individuals judged inappropriate for the trial by the principal.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Toshifumi
Middle name
Last name Ohkusa
Organization Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch
Division name Head of Center
Zip code 110-0005
Address 1-20-11 Ueno Taito-ku Tokyo 110-0005, JAPAN
TEL +81-3-5816-0711
Email info@tes-h.co.jp

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 113-0033
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

Sponsor
Institute TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization Ajinomoto Co., Inc.
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 The Ethics Committee of the Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch
Address 1-20-11 Ueno Taito-ku Tokyo 110-0005, JAPAN
Tel +81-3-5816-0711
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
2019 Year 04 Month 29 Day

Related information
URL releasing protocol N/A
Publication of results Unpublished

Result
URL related to results and publications N/A
Number of participants that the trial has enrolled 30
Results
The test product showed its efficacy and safety.
Results date posted
2019 Year 09 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Males: 23 (47.3 +_ 9.9 years old).
Females: 7 (54.7 +_ 5.7 years old).
Participant flow
30 individuals were selected from 66 candidates.
Adverse events
N/A.
Outcome measures
*Primary outcomes
[1]Electroencephalography measurement with SleepScope (Day 0, 5 days of the observation period I, 5 days of the observation period II, 5 days of the observation period III) 
[2]OSA sleep inventory (Screening, Day 0, 5 days of the observation period I, 5 days of the observation period II, 5 days of the observation period III)

[1]Epworth Sleepiness Scale (ESS) (Screening, Day 0, 5th day of the observation period I, 5th day of the observation period II, 5th day of the observation period III)
[2]Visual analogue scale for exhilarating feeling upon waking (Screening, Day 0, 5th day of the observation period I, 5th day of the observation period II, 5th day of the observation period III)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 02 Month 08 Day
Date of IRB
2018 Year 02 Month 23 Day
Anticipated trial start date
2018 Year 03 Month 08 Day
Last follow-up date
2018 Year 04 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 27 Day
Last modified on
2019 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035707

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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