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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026524
Receipt No. R000030418
Scientific Title Effect of Daily Ingestion of High-Lycopene Tomato "PR-7" on Lipid Metabolism for 8 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group
Date of disclosure of the study information 2017/03/13
Last modified on 2018/03/19

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Basic information
Public title Effect of Daily Ingestion of High-Lycopene Tomato "PR-7" on Lipid Metabolism for 8 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group
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 8 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group
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 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
1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code
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
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Health Information Science Center
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2017 Year 02 Month 13 Day
Date of IRB
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

Other
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

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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