UMIN-CTR Clinical Trial

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
Email	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
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	KAGOME CO., LTD.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048870