UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048733 |
|---|---|
| Receipt number | R000055524 |
| Scientific Title | Effects of crocetin on sleep |
| Date of disclosure of the study information | 2022/08/23 |
| Last modified on | 2023/01/06 18:17:19 |
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Basic information
Public title
Effects of crocetin on sleep
Acronym
Sleep test
Scientific Title
Effects of crocetin on sleep
Scientific Title:Acronym
Sleep test
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effect on sleep during crocetin ingestion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indexes on sleeping
Key secondary outcomes
Questionnaire
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
Consume foods containing crocetin once a day just before bedtime for 1 week.
Interventions/Control_2
Consume a placebo food containing no crocetin once a day just before bedtime for 1 week.
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
| 45 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Healthy males and females aged 45 to 74 years-old.
-Subjects who are a manager or higher and have some sleep complaints or have no sleep complaints according to the pre-sleep questionnaire.
-Subjects who can make self-judgment and arevoluntarily giving written informed consent.
Key exclusion criteria
-Subjects who have taken, or will take during the study period, drugs (e.g., antiallergic drugs, sleep inducing drugs, sleep aids, etc.) that may affect the study one month prior to the start of intake of the study foods.
-Subjects who regularly consume food for specified health use, functional foods, supplements, or health foods that may affect the study more than 3 times a week, and those who are unable to limit their intake during the study period.
-Subjects who with a history or current history of serious heart, liver, kidney, or gastrointestinal diseases.
-Subjects who suspected chronic or acute serious infectious diseases.
-Subjects who are scheduled to be vaccinated during the study period.
-Subjects who are pregnant or planning to become pregnant or breastfeed during the study period.
-Subjects who have excessive alcohol.
-Subjects who with extremely irregular eating habits.
-Subjects who has a BMI of 30 or higher.
-Subjects who plan to change their lifestyle drastically during the study period.
-Subjects whose sleep may be disturbed by external factors (e.g., roommates or pets).
-Subjects who allergic to food.
-Subjects who are currently participating in a clinical study of another drug or health food and who plan to participate in another clinical study within one month after the completion of the study or after giving consent to participate in the study.
-Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Ishihara |
Organization
Calbee, Inc.
Division name
Research Department Research & Development Division
Zip code
321-3231
Address
23-6, Kiyohara-kogyodanchi, Utsunomiya, Tochigi, 321-3231, Japan
TEL
+81-80-5952-8671
k_ishihara@calbee.co.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Osuka |
Organization
Calbee, Inc.
Division name
Functional Research Section Research Department Research & Development Division
Zip code
321-3231
Address
23-6, Kiyohara-kogyodanchi, Utsunomiya, Tochigi, 321-3231, Japan
TEL
+81-70-7795-8386
Homepage URL
y_osuka@calbee.co.jp
Sponsor or person
Institute
Calbee, Inc.
Institute
Department
Personal name
Funding Source
Organization
Calbee, 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
+81-3-5297-5548
IRB@cpcc.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 | 08 | Month | 23 | 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 | 04 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 23 | Day |
Last modified on
| 2023 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055524
