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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039504
Receipt No. 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

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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
Email 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
Email yoshiyuki.shirakura@fujifilm.com

Sponsor
Institute Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045047

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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