UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037435 |
|---|---|
| Receipt number | R000042642 |
| Scientific Title | The evaluation of the absorption of lycopene derived from processed tomato extract compared to natural tomato extract -A Randomized, Double-blind, Placebo-controlled Crossover trial- |
| Date of disclosure of the study information | 2020/07/17 |
| Last modified on | 2023/06/30 10:47:36 |
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Basic information
Public title
The evaluation of the absorption of lycopene derived from processed tomato extract compared to natural tomato extract
-A Randomized, Double-blind, Placebo-controlled Crossover trial-
Acronym
The evaluation of the absorption of lycopene derived from processed tomato extract
Scientific Title
The evaluation of the absorption of lycopene derived from processed tomato extract compared to natural tomato extract
-A Randomized, Double-blind, Placebo-controlled Crossover trial-
Scientific Title:Acronym
The evaluation of the absorption of lycopene derived from processed tomato extract
Region
| Japan |
Condition
Condition
None(Healthy subjects)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A double-blind, placebo-controlled crossover trial will be conducted to evaluate blood kinetics of lycopene upon ingestion of foods containing processed tomato extract regarding the absorption of lycopene to serum.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the serum lycopene concentration at each sampling point and AUC 0-12h of lycopene after intake of processed tomato extract with normal tomato extract(The analysis of actual measured values and the amount of changes values from baseline after the loading tomato extracts).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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 ingestion of the natural extract - washout period(6 days or more)- single ingestion of the processed extract
Interventions/Control_2
single ingestion of the processed extract - washout period(6 days or more)- single ingestion of the natural extract
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Japanese males and females from 20 to 59 years old when the consent is obtained
2)Healthy participants
3)Subjects who can be collected their blood multiple times(6 times per day)
4)Subjects with the normal fasting serum triglyceride value and LDL-cholesterol value
Key exclusion criteria
1)Subjects who are pregnant.
2)Smokers.
3)Subjects with a history of cancers or gastrointestinal diseases (except appendicitis).
4)Subjects who take the medicine related to lipids absorption.
5)Subjects who take the same medicine habitually.
6)Subjects with diseases such as autoimmune diseases, chronic inflammatory diseases and the diabetes mellitus.
7)Subjects who take the excessive alcohol(equivalent alcohol to 633 mL of beer or more at least 5 days a week).
8)Subjects who participate in another clinical trial.
9)Subjects with serious anemia.
10)Subjects who donated 200 mL or 400 mL whole blood or were transfused within 3 months before the screening.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
105-0013
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japa
TEL
03-5408-1599
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Shirakura |
Organization
FUJIFILM Healthcare Laboratory Co., Ltd.
Division name
Department of Supplement product management
Zip code
206-0024
Address
6F Kenkyu Bld., 2-5-1, Suwa, Tama-shi, Tokyo
TEL
042-339-8926
Homepage URL
yoshiyuki.shirakura@fujifilm.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Corporation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic
Address
6F DaiwaA Hamamatsucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1590
jimukyoku@mail.souken-r.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
| 2020 | Year | 07 | Month | 17 | 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
| 2019 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 20 | Day |
Last modified on
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042642
