UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042809 |
|---|---|
| Receipt number | R000048870 |
| Scientific Title | Evaluation of effects of combination of tomato and test food on bioavailability of nutrients |
| Date of disclosure of the study information | 2020/12/23 |
| Last modified on | 2022/06/17 08:20:48 |
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Basic information
Public title
Evaluation of effects of combination of tomato and test food on bioavailability of nutrients
Acronym
Evaluation of effects of combination of tomato and test food on bioavailability of nutrients
Scientific Title
Evaluation of effects of combination of tomato and test food on bioavailability of nutrients
Scientific Title:Acronym
Evaluation of effects of combination of tomato and test food on bioavailability of nutrients
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Evaluate effects of combination of tomato and test food on bioavailability of the nutrients from tomato
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Levels of the nutrients in blood
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the placebo food once a day
-> washout period (about 7 days)
-> consumption of the active food once a day
Interventions/Control_2
Consumption of the active food once a day
-> washout period (about 7 days)
-> consumption of the placebo food once a day
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females aged 20 to 39 years old when informed consent acquisition
2) Subjects giving written informed consent
Key exclusion criteria
1) Subjects with BMI > 25 kg/m^2
2) Subjects with hyperlipidemia
3) Subjects with history of digestive surgical operation
4) Subjects who receive treatments and medications
5) Subjects with low bioavailability of the nutrients
6) Subjects who consume raw tomatoes, tomato juice, or processed tomato products more than 3 days per week
7) Subjects who are pregnant or breast-feeding or willing to be pregnant during this study
8) Subjects who have allergic to active food or placebo food
9) Subjects who habitually smoke
10) Subjects who participate in other clinical trials when informed consent acquisition
11) Others who have been determined ineligible by principal investigator
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Shigenori |
| Middle name | |
| Last name | Suzuki |
Organization
KAGOME CO., LTD.
Division name
Nature & Wellness Research Department
Zip code
3292762
Address
17 Nishitomiyama, Nasushiobara city, Tochigi, Japan
TEL
0287-36-2935
Shigenori_Suzuki@kagome.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KAGOME CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
CPCC Company Limited
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagome Ethics Committee
Address
3-21-1, F tower, Hamacho, Nihonbashi, Tyuo-ku, Tokyo, Japan
Tel
03-5623-8501
Takuji_Hayakawa@kagome.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-R18
Org. issuing International ID_1
Kagome Ethics Committee
Study ID_2
KGM20C1
Org. issuing International ID_2
Institutional Review Board of Chiyoda Paramedical Care Clinic
IND to MHLW
Institutions
Institutions
チヨダパラメディカルケアクリニック
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
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
Main results already published
Date of protocol fixation
| 2020 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | 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
| 2020 | Year | 12 | Month | 22 | Day |
Last modified on
| 2022 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048870
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
