UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045643 |
|---|---|
| Receipt number | R000052106 |
| Scientific Title | Effects of long-term amino acid intake on sleep in the elderly and healthy adults |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2021/10/02 18:09:12 |
* 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
Effects of long-term amino acid intake on sleep in the elderly and healthy adults
Acronym
Effect of morning amino acid intake on sleep
Scientific Title
Effects of long-term amino acid intake on sleep in the elderly and healthy adults
Scientific Title:Acronym
Effect of morning amino acid intake on sleep
Region
| Japan |
Condition
Condition
Healthy, elderly
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the effects of long-term intake of amino acid powder on sleep and oxidative stress
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint will be a sleep questionnaire.
(3 and 6 weeks after intake)
Key secondary outcomes
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take glycine for 6 weeks. 0.05 g/kg for the first 3 weeks and 0.1 g/kg for the following 3 weeks.
Interventions/Control_2
Take alanine for 6 weeks. 0.05 g/kg for the first 3 weeks and 0.1 g/kg for the following 3 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Ability to consume amino acid powders.
Key exclusion criteria
People who cannot take the amino acid powder. In addition, people who cannot obtain permission to participate in the study from their doctor, if they have one.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hisami |
| Middle name | |
| Last name | Okumura |
Organization
Tokushima university
Division name
Department of Clinical Nutrition and Food Management
Zip code
770-8503
Address
kuramoto-cho 3-18-15, Tokushima-city
TEL
088-633-7093
okumurah@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisami |
| Middle name | |
| Last name | Okumura |
Organization
Tokushima university
Division name
Department of Clinical Nutrition and Food Management
Zip code
770-8503
Address
kuramoto-cho 3-18-15, Tokushima-city
TEL
088-633-7093
Homepage URL
okumurah@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima university
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Noom Japan, Charitable Trust Suzuyo Nakatani Memorial Nutrition Improvement Activity Promotion Fund
IRB Contact (For public release)
Organization
University Hospital of Tokushima Clinical Trial Center for Developmental Therapeutics
Address
kuramoto-cho,2-50-1, Tokushima-city
Tel
088-633-7958
first-ec@tokushima-u.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
| 2023 | 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
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
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 11 | Month | 05 | 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
| 2021 | Year | 10 | Month | 02 | Day |
Last modified on
| 2021 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052106
