UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058138 |
|---|---|
| Receipt number | R000066450 |
| Scientific Title | Evaluation of the Effects of Glycine Intake on Sleep in Collegiate Athlete |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/10 13:34:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on the effects of glycine on the sleep of college athletes
Acronym
The effects of glycine on athletes' sleep
Scientific Title
Evaluation of the Effects of Glycine Intake on Sleep in Collegiate Athlete
Scientific Title:Acronym
Glycine, sleep, and athletes
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to investigate the effects of glycine on sleep in college track and field athletes using physiological methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective sleep assessment
Sleep architecture
Key secondary outcomes
Core Body Temperature
Sleep architecture
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
glycine intake (1 min)
Interventions/Control_2
Core body temperature measurement (during sleep, approximately 7 hours)
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Members of the Waseda University Men's Track and Field club
2) Those who scored 5 or more but less than 10 on the Athlete Sleep Screening Questionnaire (ASSQ)
3) Those who are 18 years of age or older and 30 years of age or younger at the time of obtaining consent
4) Those who have received sufficient explanation about participation in the study, fully understand it, and have provided written consent of their own free will
Key exclusion criteria
1)Individuals who currently regularly consume amino acid supplements
2) Individuals with mental disorders or sleep disorders who are undergoing regular outpatient treatment and medication
3) Individuals currently undergoing treatment for physical illnesses or injuries
4)Individuals with gastrointestinal disorders (e.g., ulcerative colitis, Crohn's disease) or a history of abdominal surgery
5) Individuals weighing 40 kg or less
6)Individuals with swallowing difficulties
7)Individuals with plans to undergo MRI or other electromagnetic wave exposure on the day of or the day after the experiment
8)Individuals who have previously experienced issues with capsule ingestion
9)Individuals who regularly use nicotine
10)Individuals with travel plans during the intervention period (including the washout period)
11)Individuals participating in other studies during the course of this study
12)Individuals deemed by the principal investigator to be at risk of health compromise due to participation in the experiment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | MASAKI |
| Middle name | |
| Last name | NISHIDA |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192 JAPAN
TEL
04-2947-6771
nishida@waseda.jp
Public contact
Name of contact person
| 1st name | MASAKI |
| Middle name | |
| Last name | NISHIDA |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192 JAPAN
TEL
0429476771
Homepage URL
nishida@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co.,Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University Ethics Review Committee for Research Involving Human Subjects
Address
Room 101, Building No. 121, Waseda University 513 Tsurumaki-cho, Waseda, Shinjuku-ku, Tokyo 162-0041, Japan
Tel
03-5272-1639
rinri@list.waseda.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
早稲田大学スポーツ科学学術院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 01 | 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
| 2025 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2032 | 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
| 2025 | Year | 06 | Month | 10 | Day |
Last modified on
| 2025 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066450
