UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Daily Ingestion of High-Lycopene Tomato "PR-7" on Lipid Metabolism for 8 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group
Title of the study (Brief title)	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 clinical benefits associated with 8 week daily ingestion of high-lycopene tomato "PR-7" on lipid metabolism. Additionally to examine anti-oxidant effects, reduction of VFA, improvement of glucose metabolism, and anti-fatigue effects in order to evaluate the comprehensive effects of high-lycopene tomato "PR-7" for health promotion and health maintenance.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	TC, LDL-C, HDL-C, TG, LDL-C/HDL-C, and non-HDL at 4 and 8 weeks after beginning the ingestion of test food.
Key secondary outcomes	serum lycopene, serum alpha-carotene, serum beta-carotene, serum vitamin A, MDA-LDL, serum-LPO, urinary isoprostane, urinary HEL, LOX-index, sLOX-1, LAB, visceral fat area (using impedance methods), abdominal subcutaneous fat area (using impedance methods), abdominal fat area (using impedance methods), body weight, body fat percentage, BMI, waist, FPG, HbA1c, blood pressure, POMS 2 full-length versions for adults, VAS questionnaire assessed fatigue, stress etc.

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	No need to know

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 8 weeks.
Interventions/Control_2	Daily ingestion of 50 g semi-dried tomato of placebo tomato (lycopene-free tomato) for 8 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	35 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. Subjects whose LDL-C is >=120 mg/dl and <160 mg/dl. 2. Subjects who agree to participate in this study with a written informed consent.
Key exclusion criteria	1. Subjects who are under physician's advice, treatment, and/or medication for dyslipidemia, diabetes, and/or obesity. 2. Subjects whose BMI is >=30 kg/m2. 3. Subjects with familial hypercholesterolemia. 4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 5. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 6. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 7. Subjects with severe anemia. 8. Pre- or post-menopausal women complaining of obvious physical changes. 9. Subjects who are at risk of having allergic reactions to drugs or foods especially based on tomato, Japanese cedar, Japanese cypress, or grass. 10. Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood lipid levels. 11. Subjects who regularly take medicine, functional foods, and/or supplements which would affect glucose metabolism. 12. Subjects who regularly take drugs, functional foods, and/or supplements which would affect BW and BFP. 13. Smokers. 14. Alcohol addicts or subjects with eating disordered lifestyle. 15. 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. 16. Pregnant or lactating women or women who expect to be pregnant during this study. 17. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 18. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size	26

Research contact person
Name of lead principal investigator	Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
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	Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Health Information Science Center
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

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

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	2017 Year 03 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 13 Day
Anticipated trial start date	2017 Year 05 Month 27 Day
Last follow-up date	2017 Year 07 Month 31 Day
Date of closure to data entry	2017 Year 09 Month 18 Day
Date trial data considered complete	2017 Year 09 Month 25 Day
Date analysis concluded	2018 Year 02 Month 22 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 13 Day
Last modified on	2018 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030418