UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039504 |
|---|---|
| Receipt number | R000045047 |
| Scientific Title | The clinical trial of blood kinetics upon the ingestion of fat-soluble foods. -A Randomized Double-blind Placebo-controlled Crossover trial- |
| Date of disclosure of the study information | 2020/12/31 |
| Last modified on | 2020/02/17 13:11:19 |
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Basic information
Public title
The clinical trial of blood kinetics upon the ingestion of fat-soluble foods.
Acronym
The clinical trial of blood kinetics upon the ingestion of fat-soluble foods.
Scientific Title
The clinical trial of blood kinetics upon the ingestion of fat-soluble foods.
-A Randomized Double-blind Placebo-controlled Crossover trial-
Scientific Title:Acronym
The clinical trial of blood kinetics upon the ingestion of fat-soluble foods.
-A Randomized Double-blind Placebo-controlled Crossover trial-
Region
| Japan |
Condition
Condition
None(Healthy subjects)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate blood kinetics of lycopene upon ingestion of foods containing processed tomato extract and to confirm the absorption of lycopene to the serum by a double-blind, placebo-controlled crossover trial.
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 of AUC 0-36h of lycopene between intake of processed tomato extract and normal tomato extract(The analysis of actual measured values and variation 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
A single ingestion of the natural extract - washout period(6 days or more)- single ingestion of the processed extract
Interventions/Control_2
A 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females from 20 to 64 years old when the consent is obtained
2) Subjects with the normal fasting serum triglyceride, HDL-cholesterol and LDL-cholesterol values at the screening test.
3) Subjects available at every designated visit.
4) Subjects who agree to participate in this study and can put a signature and date to informed consent form by themselves prior to the study.
Key exclusion criteria
(1) Subjects with hepatic, renal, cardiac or organ disorders or diabetes or other serious diseases.
(2) Subjects with a surgical history of the digestive system (except appendicectomy).
(3) Subjects with a history of a drug or food allergy.
(4) Subjects currently under treatment with chronic diseases.
(5) Subjects who are pregnant or intend to become pregnant during the study or are lactating.
(6) Subjects who cannot restrict the intake of foods that may influence the measurement of the samples during the study.
(7) Subjects who take excessive alcohol (equivalent to 60 g pure ethanol/day in average consumption).
(8) Subjects who participate in other clinical trials.
(9) Subjects who have a history of feeling ill or unwell during or after the blood draw.
(10) Subjects who have donated over 400 mL of blood within the last three months prior to the screening of this study or expect to donate the same during the study.
(11) Subjects with extremely irregular diet (night-shift worker, etc).
(12) Subjects who have smoked within 6 months.
(13) Subjects who need to avoid taking the foods that do not clearly indicate the origin of all ingredients, because of religions, etc.
(14) Subjects judged as unsuitable for this study by the investigator for other reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Takano |
Organization
Medical Corporation Hokubukai
Utsukushigaoka Hospital
Division name
Clinical Pharmacology Center
Zip code
004-0839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL
011-882-0111
takano@ughp-cpc.jp
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
Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Healthcare Laboratory 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 Medical Corporation Hokubukai Utsukushigaoka Hospital
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel
011-881-0111
Matsuda@ughp-cpc.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
医療法人北武会 美しが丘病院 （北海道）
(Medical Corporation Hokubukai Utsukushigaoka Hospital (Hokkaido))
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 31 | 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 | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 04 | 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
| 2020 | Year | 02 | Month | 17 | Day |
Last modified on
| 2020 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045047
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