UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of daily ingestion of Kishu plum ( Prunus mume) on arteriosclerosis and lipid metabolism: a double-blind, placebo-controlled, parallel group comparison study.
Title of the study (Brief title)	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	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	Center of Health Information Science
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	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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023331