UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038264 |
|---|---|
| Receipt number | R000043617 |
| Scientific Title | Research on the dynamic changes of amino acids in the body after intaking amino acid containing foods |
| Date of disclosure of the study information | 2019/10/21 |
| Last modified on | 2023/04/18 15:46:37 |
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Basic information
Public title
Research on the dynamic changes of amino acids in the body after intaking amino acid containing foods
Acronym
Research on the dynamic changes of amino acids in the body after intaking amino acid containing foods
Scientific Title
Research on the dynamic changes of amino acids in the body after intaking amino acid containing foods
Scientific Title:Acronym
Research on the dynamic changes of amino acids in the body after intaking amino acid containing foods
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the dynamic changes of amino acids in the body after intaking amino acid containing foods
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To analyze the changes of amino acid concentrations in the blood.
(Amino acids to be analyzed; those included in the test food, those not included in the test food, the metabolites.)
To simulate the inflow speed of amino acids and the metabolites using the uptake kinetics of amino acid transporters that are being expressed on human BBB based on the changes of blood amino acid concentrations.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Group 1: 1 course to 2 course
2 Intake Conditions Crossover
1 Course (medium-dose intakes between meals)
2 Course (low-dose intakes before meals)
Interventions/Control_2
Group 2: 2 course to 1 course
2 Intake Conditions Crossover
1 Course (medium-dose intakes between meals)
2 Course (low-dose intakes before meals)
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy male and female subjects who are 40 years and older.
Who can be participated in the study at designated times and places on the planned study dates.
Who have provided with the documented consent by his/her own will after having received the thorough explanation and understand about the study participation.
Key exclusion criteria
Who has been commented on any cognitive declines or diagnosed with dementia from physicians.
Who is under treatment for any life style related disease such as Diabetes Mellitus, Hyperlipidemia, or Hypertension.
Who is under medication.
Who has cancer (diagnosis and under treatment), or is within 5 years after the completion of cancer treatment.
Who has current diseases such as Cirrhosis, Renal failure, congenital metabolic disease of amino acids or who is on Hemodialysis.
Who has a history of surgery on any digestive organs or liver, gall bladder, pancreas. (Appendectomy is acceptable)
Who has Alcohol dependency, nicotine dependency.
Who has any food allergies or is lactose intolerant.
Who has anemia, malnutrition, or viral diseases or any serious diseases or symptoms.
Who has been taking any amino acids or protein enhancement food/supplements within 1 month from the first consumption of the study food.
Who has taken more than 200 mL of blood within 1 month.
Who is currently participating in any other studies that involves using any foods, cosmetics or medications.
Who has been confirmed any abnormal clinical values of the level of [Medical Consultation needed] at a screening test.
Who has been considered ineligible by the study doctor.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Kageyama |
Organization
Ajinomoto Co.,Inc.
Division name
Research Inst. Bioscience Product & Fine Chemicals
Zip code
210-8681
Address
1-1. Suzuki-Cho, Kawasaki-Ku, Kawasaki-Shi 210-8681, Japan
TEL
044-210-5835
yoko_kageyama@ajinomoto.com
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Tagami |
Organization
Ajinomoto Co.,Inc.
Division name
Research Inst. Bioscience Product & Fine Chemicals
Zip code
210-8681
Address
1-1. Suzuki-Cho, Kawasaki-Ku, Kawasaki-Shi 210-8681, Japan
TEL
044-210-5835
Homepage URL
tomoyuki_tagami@ajinomoto.com
Sponsor or person
Institute
SOUSEIKAI Sumida Hospital
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
HAKATA Clinic IRB
Address
6-18 Tenyamachi Hakata -ku Fukuoka
Tel
092-283-7701
miyako-koga@lta-med.com
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
| 2019 | Year | 10 | Month | 21 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
15
Results
We confirmed the time course of blood amino acid concentration when ingesting amino acid-containing foods before and between meals, and obtained the kinetic data of amino acids for considering the intake dose and the effect of meals.
Results date posted
| 2021 | Year | 10 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy volunteer
Participant flow
The study was conducted on 15 people who met the eligibility criteria. One of them dropped out on the second course.
Adverse events
No adverse events were observed.
Outcome measures
Changes in blood amino acid concentration due to ingestion of amino acid-containing foods.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 24 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 10 | Day |
Last modified on
| 2023 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043617
