UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055719 |
|---|---|
| Receipt number | R000063673 |
| Scientific Title | Study to Confirm the Effects of a Single Intake of Amino Acid-Containing Foods on Fatigue and Mood -a placebo-controlled, randomized, parallel-group, double-blind study.- |
| Date of disclosure of the study information | 2024/10/03 |
| Last modified on | 2025/03/19 18:36:37 |
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Basic information
Public title
Study to Confirm the Effects of a Single Intake of Amino Acid-Containing Foods on Fatigue and Mood
-a placebo-controlled, randomized, parallel-group, double-blind study.-
Acronym
Study to Confirm the Effects of a Single Intake of Amino Acid-Containing Foods on Fatigue and Mood
-a placebo-controlled, randomized, parallel-group, double-blind study.-
Scientific Title
Study to Confirm the Effects of a Single Intake of Amino Acid-Containing Foods on Fatigue and Mood
-a placebo-controlled, randomized, parallel-group, double-blind study.-
Scientific Title:Acronym
Study to Confirm the Effects of a Single Intake of Amino Acid-Containing Foods on Fatigue and Mood
-a placebo-controlled, randomized, parallel-group, double-blind study.-
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm if a single intake of amino acids improves fatigue and mood.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS 2 short version
Key secondary outcomes
VAS
Cognitive function (Cognitrax performance, number of responses and percentage of correct responses to Uchida-Klepelin test)
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
Single intake of test food
Interventions/Control_2
Single intake of placebo (control food)
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Men and women who are between 30 and 60 years of age at the time consent is obtained and who experience fatigue and sleep deprivation on a daily basis.
2) Those who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1) Currently undergoing treatment with some kind of drug or herbal medicine.
2) Currently taking supplements or health foods related to relieving fatigue and improving sleep, or who cannot withdraw these during the study period.
3) Consume bluefish on a daily basis at least twice a week.
4) Has a significant chronic disease or is in the process of treating a disease.
5) BMI greater than 30 kg/m2 at the time of SCR inspection.
6) Have a smoking habit, and less than 1 year after quitting smoking.
7) Have unstable lifestyles such as shift workers, and night shifts.
8) Participating or intends to participate in a study involving the ingestion of other foods, the use of drugs, or the application of cosmetics or drugs.
9) Had a death of a relative, pet, etc. within the past 3 months.
10) Current or history of food allergy.
11) Has menopausal symptoms, premenstrual syndrome or severe premenstrual dysphoric mood disorder.
12) Perceived that he/she is good at or likes to do calculations and mental arithmetic.
13) Has had a vasovagal reflex in the past.
14) Currently pregnant or lactating, and hoping to become pregnant during the study period.
15) Judged by the principal investigator to be inappropriate as research subjects.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hidehiro |
| Middle name | |
| Last name | Nakamura |
Organization
Ajinomoto Co., Inc.
Division name
Research Institute for Bioscience Products and Fine Chemicals
Zip code
210-8681
Address
1-1 Suzuki-cho, Kawasaki-ku, Kawasaki City, Kanagawa Prefecture
TEL
070-1002-5548
hidehiro.nakamura.ru3@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Masatsugu |
| Middle name | |
| Last name | Shimomasuda |
Organization
Ajinomoto Co., Inc.
Division name
Research Institute for Bioscience Products and Fine Chemicals
Zip code
210-8681
Address
1-1 Suzuki-cho, Kawasaki-ku, Kawasaki City, Kanagawa Prefecture
TEL
080-2427-6713
Homepage URL
masatsugu.shimomasud.3de@asv.ajinomoto.com
Sponsor or person
Institute
Ajinomoto Co., Inc.
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., 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
Suda Clinic institutional review board
Address
2-8-14 Takadanobaba, Shinjuku-ku, Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
IQRD-08-009
Org. issuing International ID_1
IMEQRD Co., Ltd.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人社団 浩央会 東小金井さくらクリニック
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 03 | 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
| 2024 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 22 | Day |
Date of closure to data entry
| 2024 | Year | 11 | Month | 22 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063673
