UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055634 |
|---|---|
| Receipt number | R000063551 |
| Scientific Title | Study on the Vitamin E Absorption after ingestion of Test Foods in Healthy Adults -a randomised-controlled crossover |
| Date of disclosure of the study information | 2024/10/06 |
| Last modified on | 2024/09/26 16:02:30 |
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Basic information
Public title
Study on the Vitamin E Absorption after ingestion of Test Foods in Healthy Adult
Acronym
Study on the Vitamin E Absorption after ingestion of Test Foods in Healthy Adults
Scientific Title
Study on the Vitamin E Absorption after ingestion of Test Foods in Healthy Adults -a randomised-controlled crossover
Scientific Title:Acronym
Study on the Vitamin E Absorption after ingestion of Test Foods in Healthy Adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study on the differences in absorption of vitamin E by test foods
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of vitamin E (as alpha-tocopherol) in blood, transfer rate (CMAX from 0h to 10h), and AUC 0-48h for postprandial serum total vitamin E 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
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food 1 (single ingestion) - washout period - intake of test food 2 (single ingestion) - washout period - intake of test food 3 (single ingestion).
Interventions/Control_2
Intake of test food 2 (single ingestion) - washout period - intake of test food 3 (single ingestion) - washout period - intake of test food 1 (single ingestion).
Interventions/Control_3
Intake of test food 3 (single ingestion) - washout period - intake of test food 1 (single ingestion) - washout period - intake of test food 2 (single ingestion).
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Males and females aged 20 to 60 years.
2. Subjects who are Generally healthy.
3. Subjects who can voluntarily provide written consent to participate in the study.
Key exclusion criteria
1.Subjects who are continuously consuming health foods, quasi-drugs, or medicines that claim or emphasize efficacy or effects similar to or related to the efficacy being investigated in this study.
2.Subjects who have changed or newly started using health foods within the past four weeks.
3.Subjects engaged in night shifts or rotating day and night shifts.
4.Subjects who, at the time of consent acquisition, are receiving treatment or preventive care at a medical institution (hormone replacement therapy, drug therapy, exercise therapy, diet therapy, etc.) or are judged to require treatment.
5.Subjects with, or with a history of, disorders of glucose metabolism, lipid metabolism, liver function, kidney function, heart, cardiovascular system, respiratory system, endocrine system, immune system, or nervous system.
6.Subjects with a history of alcohol or drug dependency.
7.Subjects at risk of developing an allergic reaction to almonds or other nuts.
8.Subjects who are pregnant, breastfeeding, or intend to become pregnant during the study period at the time of consent acquisition.
9.Subjects who have experienced discomfort or worsening of their condition due to blood collection in the past, or those who have been told that blood collection is difficult due to thin veins.
10.Subjects who have participated in other human trials (e.g., those involving foods, drugs, quasi-drugs, medical devices, etc.) within the past four weeks, or those planning to participate in another human trial during the scheduled study period.
11.Subjects who have difficulty consuming the test food (e.g., those unable to chew and consume almonds).
12.Subjects who are deemed inappropriate for participation by the principal investigator or study director.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Kondo |
Organization
Medical Corpoation Kenshokai Fukushima Healthcare Center
Division name
Director
Zip code
553-0004
Address
2-12-16, Tamagawa, Fukushima-ku, Osaka, Japan
TEL
06-6441-6848
drc_shokuhin@drc-web.co.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Furusho |
Organization
DRC Co., Ltd.
Division name
Product Testing Department
Zip code
530-0044
Address
No.9 Tabuchi Bldg. 3F, 2-10-31, Higashi-Temma, Kita-ku, Osaka
TEL
06-6882-1130
Homepage URL
furusyo@drc-web.co.jp
Sponsor or person
Institute
DRC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico 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
Brain Care Clinic Ethics Review Committee
Address
Hakutyo Build.2F,2-1-2 Shinjuku,Sinjuku-ku,Tokyo
Tel
03-6273-2214
Ethics_boad@drc-web.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
| 2024 | 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
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
| 2024 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2024 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063551
