UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031975 |
|---|---|
| Receipt number | R000036503 |
| 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 |
| Date of disclosure of the study information | 2018/03/29 |
| Last modified on | 2019/08/05 19:41:09 |
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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
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
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036503
