UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048981 |
|---|---|
| Receipt number | R000055796 |
| Scientific Title | Effects of Consumption of the Test Food on Sleep Quality, Fatigue and Quality of Life. |
| Date of disclosure of the study information | 2022/09/24 |
| Last modified on | 2023/06/27 11:00:09 |
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Basic information
Public title
Effects of Consumption of the Test Food on Sleep Quality, Fatigue and Quality of Life.
Acronym
Effects of Consumption of the Test Food on Sleep Quality, Fatigue and Quality of Life.
Scientific Title
Effects of Consumption of the Test Food on Sleep Quality, Fatigue and Quality of Life.
Scientific Title:Acronym
Effects of Consumption of the Test Food on Sleep Quality, Fatigue and Quality of Life.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effects of consumption of the test food on sleep quality, fatigue and quality of life.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OSA sleep inventory
(Screening, 2nd week of the observation period I: 8 days, and 2nd week of the observation period II: 8 days.)
Key secondary outcomes
*Secondary indexes
[1] Electroencephalography measurement during sleep with SleepScope.(1)
[2] St. Mary's Hospital Sleep Questionnaire.(2)
[3] Japanese Edition of Profile of Mood States.(2)
[4] Visual Analogue Scale.(3)
[5] Activity survey (Subject's diary).(4)
*Safety
[1] Blood pressure, pulsation.(2)
[2] Weight, body fat percentage, BMI.(2)
[3] Doctor's questions/ Side effects/ Adverse events.(2)
[4] Subject's diary.(4)
*Other indexes
[1] Baseline characteristics.(5)
[2] Hematologic test.(5)
[3] Blood biochemical test.(5)
[4] Urine analysis.(5)
[5] Height measurement.(5)
[6] Waist girth, hip girth.(5)
[7] Pittsburgh Sleep Quality Index (PSQI-J).(5)
[8] Munich ChronoType Questionnaire-Japanese version.(5)
(1): Screening, 2nd week of the observation period I: 5days, 2nd week of the observation period II: 5days.
(2): Screening, 2nd week of the observation period I, 2nd week of the observation period II.
(3): Screening, 2nd week of the observation period I: 3days, 2nd week of the observation period II: 3days.
(4): Every day from the day before the observation period I to the day before the observation period II.
(5): 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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
[1] Oral ingestion of a test food (1 pill in a day; 2 weeks).
[2] Observation.
[3] Washout (2 weeks)
[4] Oral ingestion of a placebo food (1 pill in a day; 2 weeks).
[5] Observation.
Interventions/Control_2
[1] Oral ingestion of a placebo food (1 pill in a day; 2 weeks).
[2] Observation.
[3] Washout (2 weeks)
[4] Oral ingestion of a test food (1 pill in a day; 2 weeks).
[5] Observation.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1] Males and females aged 20-59 years.
[2] Individuals who are healthy and have no chronic physical disease.
[3] Individuals who are easily fatigued in daily life and are dissatisfied with their sleep.
[4] Individuals who go to bed (lights off) and wake up at regular times, go to bed (lights out) before midnight, and have a habit of sleeping for 4 hours or more.
[5] Individuals who sleep alone.
[6] Individuals who work five days a week during the daytime and have weekends off; who are full-time housewives but their cohabitants (spouse, children under high school age) work five days a week during the day or commute to school or work on weekdays, and have a regular lifestyle (ex. waking and sleeping times).
[7] Individuals who do not have a habit of drinking.
[8] Individuals whose written informed consent has been obtained after explanation of this study.
[9] Individuals who can have an examination on a designated check day.
[10] Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1] Individuals who are placed in an environment that interferes with sleep at bedtime.
[2] Individuals using medical products.
[3] Individuals who use a drug for treatment of disease.
[4] Individuals who are suspected patient of, a patient of, or had a history of sleep apnea syndrome.
[5] Individuals who have or are suspected patient of nocturia, benign prostatic hyperplasia, overactive bladder.
[6] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[7] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[8] Individuals who are a patient or have a history of or endocrine disease.
[9] Individuals who used a drug to treat a disease in the past 1 month.
[10] Individuals with drug and food allergies.
[11] Individuals whose BMI is over 30 kg/m2.
[12] Individuals who consume 2 or more cups of coffee or tea a day (14 or more cups per week; excepting those who can limit their intake during the EEG measurement period).
[13] Individuals who are a smoker.
[14] Individuals with serious anemia.
[15] Individuals who had a habit to ingest Food with Health Claims, health foods, 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 during the test period.
[18] Individuals who may have different sleeping conditions during the EEG measurement period.
[19] Individuals who may cause skin irritation due to the electrode adhesive pad.
[20] Individuals who are pregnant, nursing or possibly pregnant.
[21] Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[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 study by the principal.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
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
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
6F Kairaku Building 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
Karada Lab, 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
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
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
| 2022 | Year | 09 | Month | 24 | 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
| 2022 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 12 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 23 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 17 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 20 | Day |
Last modified on
| 2023 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055796
