UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056567 |
|---|---|
| Receipt number | R000064646 |
| Scientific Title | A pilot study to confirm the effect of test foods on sleep quality |
| Date of disclosure of the study information | 2025/01/11 |
| Last modified on | 2024/12/25 17:06:37 |
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Basic information
Public title
A pilot study to confirm the effect of test foods on sleep quality
Acronym
A pilot study to confirm the effect of test foods on sleep quality
Scientific Title
A pilot study to confirm the effect of test foods on sleep quality
Scientific Title:Acronym
A pilot study to confirm the effect of test foods on sleep quality
Region
| Japan |
Condition
Condition
Healty volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the test foods affect the quality of sleep in women prone to PMS.
As a preliminary study, we will measure growth hormone levels in the blood, body composition, and skin tests to see if there is an effect on growth hormone, bone density, muscle mass, and skin condition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pittsburgh sleep quality index(PSQI)
Key secondary outcomes
Daily Record of Severity of Problems(DRSP)
Fatigue Visual Analog Scale
Body composition measurement
Skin condition
Fitbit Sleep Profiles
Blood growth hormone concentration
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of test food for 4 weeks
Interventions/Control_2
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
| 55 | years-old | > |
Gender
Female
Key inclusion criteria
1) Japanese women aged 20 to 55
2) Those who have problems with sleep quality
3) Those with a regular menstrual cycle (25-38 days)
4) Those who have a tendency towards premenstrual syndrome
5) Healthy individuals who are not undergoing treatment for any illness or taking any medication
6) Those who voluntarily wish to participate in the clinical trial and can provide written informed consent
7)Those who can maintain a consistent daily lifestyle during the test period
Key exclusion criteria
1) Those who have been taking medicines regularly within the last 3 months prior to the start of the study (excluding temporary medications such as painkillers and cold medicines)
2) Those with serious illnesses (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or mental illnesses
3) Those with a history of serious illness (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or digestive system disease
4) Those who have regularly taken specific health foods, functional foods, health foods (including supplements), etc., that may affect the study, at least three times a week within three months prior to the start of the study.
5) Those who cannot stop taking foods for specified health uses, foods with functional claims, health foods (including supplements), etc. that may affect the study during the study period.
6) Those whose menstruation has stopped completely
7) Those who are pregnant or breastfeeding, or who plan to or wish to do so during the study period
8) Those who live in an environment where sleep is disturbed by factors other than themselves, such as living with infants or people who require care
9) Those who drink a lot of alcohol (40g or more of pure alcohol per day on average)
10) Those with extremely irregular eating habits or those with irregular lifestyles such as working night shifts
11) Those with drug or food allergies
12) Participants in clinical trials related to sleep quality or PMS within 6 months of the start of the study
13) Those who are currently participating in another clinical trial, have completed a clinical trial within the last 4 weeks, or are scheduled to participate in another clinical trial while participating in this study.
14) Those who are deemed ineligible to participate in this study by the investigator
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Watanabe |
Organization
Watanabe Hospital
Division name
chairperson
Zip code
144-0043
Address
1-5-16, Haneda, Ota-ku, Tokyo, Japan
TEL
03-3741-0223
wnb.cto@gmail.com
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Uetake |
Organization
CXwellness, Inc.
Division name
Representative Directo
Zip code
173-0004
Address
2-63-9-401 Itabashi, Itabashi-ku, Tokyo JAPAN
TEL
03-6915-5507
Homepage URL
uetake@cx-wellness.com
Sponsor or person
Institute
MITSUBISHI GAS CHEMICAL COMPANY, INC.
Institute
Department
Personal name
Funding Source
Organization
MITSUBISHI GAS CHEMICAL COMPANY, 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
Ethics Review Committee of Watanabe Hospital
Address
1-5-16, Haneda, Ota-ku, Tokyo, JAPAN
Tel
03-3741-0223
wnb@cto-net.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
| 2025 | Year | 01 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 25 | Day |
Last modified on
| 2024 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064646
