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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name