UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Daily Ingestion of High-Lycopene Tomato "PR-7" on Lipid Metabolism for 12 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Acronym	Beneficial Effects of High-Lycopene Tomato "PR-7" on Lipid Metabolism
Scientific Title	Effect of Daily Ingestion of High-Lycopene Tomato "PR-7" on Lipid Metabolism for 12 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Scientific Title:Acronym	Beneficial Effects of High-Lycopene Tomato "PR-7" on Lipid Metabolism
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To prove the effect of high-lycopene tomato "PR-7" on lipid metabolism associated with 12 week daily ingestion in a randomized, double-blind, placebo-controlled, parallel group study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	LDL-C at 4, 8 and 12 weeks after beginning the ingestion of test food.
Key secondary outcomes	TC, HDL-C, TG, LDL/HDL ratio, non-HDL, serum lycopene, serum beta-carotene, adiponectin, MDA-LDL, LOX-index, sLOX-1, LAB, serum-LPO, salivary volume, salivary chromogranin A, VAS questionnaire assessed fatigue and stress, POMS-2 full-length versions for adults

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Daily ingestion of 50 g semi-dried tomato of high-lycopene tomato "PR-7" for 12 weeks.
Interventions/Control_2	Daily ingestion of 50 g semi-dried tomato of placebo tomato (lycopene-free tomato) for 12 weeks.
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	30 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1.Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent. 2.Subjects whose LDL-C is >=120 mg/dl and <160 mg/dl.
Key exclusion criteria	1. Subject who participated in the pilot study. 2. Subjects who usually do not intake raw tomatoes. 3. Subjects who usually intake tomato juice. 4. Subjects who are under physician's advice, treatment, and/or medication for dyslipidemia and/or diabetes. 5. Subjects whose BMI is >=30 kg/m2. 6. Subjects with familial hypercholesterolemia. 7. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 8. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 9. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 10. Subjects with severe anemia. 11. Pre- or post-menopausal women complaining of obvious physical changes. 12. Subjects who are at risk of having allergic reactions to drugs or foods especially based on tomato, Japanese cedar, Japanese cypress, or grass. 13. Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood lipid levels. 14. Subjects who regularly take medicine, functional foods, and/or supplements which would affect glucose metabolism. 15. Alcohol addicts or subjects with eating disordered lifestyle. 16. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study. 17. Pregnant or lactating women or women who expect to be pregnant during this study. 18. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 19. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name NISHIHIRA
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
Zip code	069-8585
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL	011-385-4411
Email	nishihira@do-johodai.ac.jp

Public contact
Name of contact person	1st name Jun Middle name Last name NISHIHIRA
Organization	Hokkaido Information University
Division name	Health Information Science Center
Zip code	069-8585
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL	011-385-4430
Homepage URL
Email	nishihira@do-johodai.ac.jp

Sponsor
Institute	Hokkaido Information University
Institute
Department

Funding Source
Organization	NARO Bio-oriented Technology Research Advancement Institution
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	TAKII & COMPANY, LIMITED
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The ethics committee of Hokkaido Information University
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel	011-385-4411
Email	soumu@do-johodai.ac.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	北海道情報大学　保健センター（北海道）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications	https://www.mdpi.com/2072-6643/11/5/1177
Number of participants that the trial has enrolled	100
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	2018 Year 02 Month 21 Day
Date of IRB	2018 Year 02 Month 21 Day
Anticipated trial start date	2018 Year 05 Month 11 Day
Last follow-up date	2018 Year 09 Month 10 Day
Date of closure to data entry	2018 Year 10 Month 23 Day
Date trial data considered complete	2018 Year 10 Month 30 Day
Date analysis concluded	2019 Year 03 Month 29 Day

Other
Other related information

Management information
Registered date	2018 Year 03 Month 29 Day
Last modified on	2019 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036503