UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020201 |
|---|---|
| Receipt number | R000023331 |
| Scientific Title | Effect of daily ingestion of Kishu plum ( Prunus mume) on arteriosclerosis and lipid metabolism: a double-blind, placebo-controlled, parallel group comparison study. |
| Date of disclosure of the study information | 2015/12/15 |
| Last modified on | 2016/10/28 09:25:57 |
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Basic information
Public title
Effect of daily ingestion of Kishu plum ( Prunus mume) on arteriosclerosis and lipid metabolism: a double-blind, placebo-controlled, parallel group comparison study.
Acronym
Beneficial Effects of Daily Ingestion of Kishu plum on Arteriosclerosis and Lipid Metabolism
Scientific Title
Effect of daily ingestion of Kishu plum ( Prunus mume) on arteriosclerosis and lipid metabolism: a double-blind, placebo-controlled, parallel group comparison study.
Scientific Title:Acronym
Beneficial Effects of Daily Ingestion of Kishu plum on Arteriosclerosis and Lipid Metabolism
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove clinical benefits associated with 12 weeks daily ingestion of Kishu plum products on arteriosclerosis and lipid metabolism. Additionally to examine intestinal regulation function, anti-fatigue and anti-oxidant effects in order to evaluate the comprehensive effects of Kishu plum products for health promotion and health maintenance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Arteriosclerosis Index, TC, LDL-C, HDL-C and TG at 4, 8 and 12 weeks after the beginning of ingestion of test meals.
Key secondary outcomes
oxo-LDL, TBARS, VAS questionnaire for lassitude and defecation, frequency of bowel movement, body composition (BW, BFR, BMI)
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of 35g of paste made from "Kishu plum treated with superheated steam" daily for 12 weeks.
Interventions/Control_2
Ingestion of 35g of "pickled plum" paste daily 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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects whose arteriosclerosis index is >=1.5.
2. Subjects who agree to participate in the current study with a written informed consent.
Key exclusion criteria
1. Subjects who are under treatmentand medication for hyperlipidemia and diabetes.
2. Subjects with familial hypercholesterolemia.
3. Subjects whose LDL-C is >=180 mg/dl.
4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, disorder of endocrine and metabolism or affected with infectious diseases which are required to report to the authorities.
5. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
6. Subjects with unusually high and/or low blood pressure or abnormal hematological data.
7. Subjects with serious anemia.
8. Pre- or post-menopausal women having
obvious changes in physical condition.
9. Subjects who are at risk of having allergic reactions to drugs or foods (especially plum and agar).
10. Subjects who regularly take drugs, functional foods and/or supplements (EPA, DHA, MCT, phytosterol, sesamin, turmeric, polyphenols, dietary fiber, etc.) which would affect the blood lipid levels.
11. Subjects who regularly take drugs, functional foods and/or supplements (containing dietary fiber such as indigestible dextrin, polyphenol, etc.)
which would affect blood glucose.
12. Heavy smokers, alcohol addicts or subjects with irregular lifestyle
13. Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study.
14. Pregnant or lactating women or women expect to be pregnant during the clinical trial.
15. Subjects who participate in other clinical trials within the last one month prior to this study.
16. Any other medical reasons judged by the
principal investigator
Target sample size
52
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
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
Center of Health Information Science
Zip code
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
VS fit co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 12 | Month | 15 | 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
| 2015 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 28 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 07 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 14 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 15 | Day |
Last modified on
| 2016 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023331
