UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045597 |
|---|---|
| Receipt number | R000051980 |
| Scientific Title | Test for confirmation of absorption of a compound by ingestion of test foods |
| Date of disclosure of the study information | 2021/10/06 |
| Last modified on | 2022/02/18 13:17:55 |
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Basic information
Public title
Test for confirmation of absorption of a compound by ingestion of test foods
Acronym
Test for confirmation of absorption of a compound by ingestion of test foods
Scientific Title
Test for confirmation of absorption of a compound by ingestion of test foods
Scientific Title:Acronym
Test for confirmation of absorption of a compound by ingestion of test foods
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm the difference between origin raw materials and food ingredient in terms of absorption of compound when taken orally.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration of intact components in blood plasma
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) 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
single oral ingestion about 250g of raw material ( fruit eatable part and seed )
Interventions/Control_2
Single oral ingestion 1250mL of food (beverages) containing food ingredients extracted and refined from raw materials.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Men and women aged 20 to 65 years at the time of obtaining consent
(2) BMI of 18.5 kg/m^2or more but less than 30.0 kg/m^2.
(3) Those who have completed two doses of the new coronavirus vaccine at least one week prior to the first test day.
(4) Those who have received sufficient explanation of the test, understand the contents, and can give written consent in person.
Key exclusion criteria
(1) People who have difficulty with acidity
(2) Those who are currently taking any medication.
(3) Those who are scheduled to take medication or receive vaccinations between one week before the first test date and the second test date.
(4) Heavy drinkers of alcohol
(5) Those who are unable to go to bed and sleep as usual the day before the test day
(6) Those who have been told that their blood vessels are too thin or that it is difficult to draw blood more than once
(7) Those who are aware that they have severe symptoms such as irregular menstruation, menstrual cramps, or symptoms related to menopausal disorders.
(8) Those who have a history or current history of serious diseases of the heart, liver, kidneys, digestive organs, etc.
(9) Those who are pregnant, lactating, or intend to become pregnant during the study period.
(10) Those with allergies to medicines or food
(11) Those who are currently participating in a clinical trial of another drug or health food, and plan to participate in another clinical trial within 4 weeks of the end of the trial, or after consenting to participate in the trial.
(12) Those who have donated component blood or 200 mL whole blood since the month prior to the start of the study.
(13) Men who have donated 400 mL of whole blood for 3 months prior to the start of the study.
(14)Women who have donated 400 mL of whole blood for 4 months prior to the start of the study
(15) Men whose total blood collection volume exceeds 1200 mL when the planned total blood collection volume for the study is added to the blood collection volume from 12 months prior to the start of the study
(16)Women whose blood volume exceeds 800 mL when the total planned blood volume for the study is added to the blood volume collected 12 months prior to the start of the study.
(17) Patients who are judged to be inappropriate for participation in the study by the principal investigator or sub-investigator.
Translated with www.DeepL.com/Translator (free version)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Matsui |
Organization
R&D Institute, MORINAGA & CO., LTD.
Division name
Health Science Research Center
Zip code
230-8504
Address
Shimosueyoshi 2-1-1 Tsurumi-ku Yokohama-si Kanagawa-ken
TEL
045-571-2982
y-matsui-jd@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Sadao |
| Middle name | |
| Last name | Mori |
Organization
R&D Institute, MORINAGA & CO., LTD.
Division name
Health Science Research Center
Zip code
230-8504
Address
Shimosueyoshi 2-1-1 Tsurumi-ku Yokohama-si Kanagawa-ken
TEL
045-571-2982
Homepage URL
s-mori-ab@morinaga.co.jp
Sponsor or person
Institute
R&D Institute, MORINAGA & CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
R&D Institute, MORINAGA & CO., LTD.
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.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
| 2021 | Year | 10 | Month | 06 | 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
10
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
Main results already published
Date of protocol fixation
| 2021 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | 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 | 09 | Month | 29 | Day |
Last modified on
| 2022 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051980
