UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053313 |
|---|---|
| Receipt number | R000060849 |
| Scientific Title | Study on the impact of test food consumption on sleep |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2024/01/10 17:23:22 |
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Basic information
Public title
Study on the impact of test food consumption on sleep
Acronym
Study on the impact of test food consumption on sleep
Scientific Title
Study on the impact of test food consumption on sleep
Scientific Title:Acronym
Study on the impact of test food consumption on sleep
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effects of consuming test foods on sleep and fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep-related questionnaire
Key secondary outcomes
VAS (fatigue, wakefulness), assessment of sleep status, fluctuations in glucose levels
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of the test food for 4 weeks
Interventions/Control_2
Oral ingestion of the pracebo food for 4 weeks
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Individuals who are healthy sports athletes, aged 18 and above at the time of consent acquisition.
2) Individuals who have received enough explanation and understood about this study, and who can obtain informed consent.
Key exclusion criteria
1)Individuals who cannot provide consent to participate in the study.
2)Individuals currently undergoing treatment for a serious illness.
3)Individuals unable to perform adequate training at the start of the study due to injuries or other reasons.
4)Individuals scheduled for surgery during the study period.
5)Individuals who have received inpatient treatment within the past six months or are planning hospitalization during the trial.
6)Individuals who regularly use medications during the study period.
7)Individuals participating in other clinical research or who have not completed a one-month period after participating in a clinical trial.
8)Individuals who regularly consume supplements rich in polyphenols outside of their diet.
9)Individuals who cannot avoid alcohol from two days before the trial starts until its completion.
10)Individuals with a habit of consuming more than 20g of pure alcohol per day, more than five days a week.
11)Individuals with a smoking habit.
12)Individuals with irregular sleep hours and habits.
13)Individuals currently receiving treatment for, or with a history of, psychiatric disorders (such as depression) or sleep disorders.
14)Individuals diagnosed with sleep apnea syndrome or aware of their own apnea episodes.
15)Individuals with symptoms of nocturia, or those under medication for non-urinary tract diseases.
16)Individuals with allergies to medications or food.
17)Individuals with metal allergies (skin troubles due to electrodes) or sensitive skin.
18)Individuals considered by the research director to be unsuitable for participation in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Sugita |
Organization
Nippon Sport Science University
Division name
School of Physical Education
Zip code
158-8508
Address
7-1-1, Fukasawa, Setagaya-ku, Tokyo
TEL
03-5706-1148
m-sugita@nittai.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Sugita |
Organization
Nippon Sport Science University
Division name
School of Physical Education
Zip code
158-8508
Address
7-1-1, Fukasawa, Setagaya-ku, Tokyo
TEL
03-5706-1148
Homepage URL
m-sugita@nittai.ac.jp
Sponsor or person
Institute
Nippon Sport Science University
Institute
Department
Personal name
Funding Source
Organization
Morinaga & Co., 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
Ethics Committee of the Nippon Sport Science University
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
Tel
03-5706-0931
rinri-shinsa@nittai.ac.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 | 03 | Month | 31 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 18 | 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 | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060849
