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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037435
Receipt No. 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 2019/07/18

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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
Email 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
Email yoshiyuki.shirakura@fujifilm.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2019 Year 07 Month 03 Day
Date of IRB
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
2019 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042642

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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