UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Double-blind, placebo-controlled study for the effect of rutin-rich processed buckwheat (Manten-kirari) on dyslipidemia and antioxidant
Title of the study (Brief title)	Effect of rutin-rich buckwheat on dyslipidemia and antioxidant
Region	Japan

Condition
Condition	dyslipidemia
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to evaluate the effect of rutin-rich buckwheat(Manten-kirari) on dyslipidemia and antioxidant by double-blind, placebo-controlled study
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	arteriosclerosis index, oxo-LDL
Key secondary outcomes	T-Cho, LDL-Cho, HDL-Cho, TG, fasting blood glucose, HbA1c, Insulin, hs-CRP, apolipoprotein(B,A-1,E), adiponectin, TBARS, SOD, 8-OHdG, body weight, BMI, body fat rate

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	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake 80g of rehydratable noodle containing 50% rutin-rich buckwheat powder daily for 12 weeks.
Interventions/Control_2	Intake 80g rehydratable noodle lack of rutin-rich buckwheat powder 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	30 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Subjects whose arteriosclerosis index are between 1.5 and 4.5. (2)Subjects who agree to participate in the current study with written informed consent.
Key exclusion criteria	(1) Subjects who are under medication for chronic ailments. (2) Subjects with serious diseases and infections. (3) Subjects with clinical history of gastrointestinal surgery. (4) Subjects with frequent complaints of post-menopausal symptoms. (5) Subjects with Familial hypercholesterolemia. (6)Subjects with unusually high and/or low blood pressure, or with abnormal hematological data. (7) Subjects with serious anemia. (8)Subjects with a history of allergy to medicine and food, especially buckwheat and wheat (9) Subjects routinely on supplementation which would affect lipid metabolism. (10) Subjects routinely on supplementation which would affect blood pressure. (11) Heavy smokers and alcohol addicts, or subjects with irregular lifestyle. (12) Subjects who donate 400ml whole blood within 12 weeks or who donate plasma or platelets within 4 weeks prior to supplementation. (13) Subjects who are pregnant or under lactation, or ones who would be expected to be pregnant during the study. (12) Subjects who participate in other clinical trials within the last one month prior to the current clinical trial. (13) Subjects who are not eligible due to physician's judgment
Target sample size	120

Research contact person
Name of lead principal investigator	Prof. Jun Nishihira, M.D.
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
Address	59-2, nishi-nopporo, ebetsu, 069-8585, Hokkaido
TEL	011-385-4411
Email	nishihira@do-johodai.ac.jp

Public contact
Name of contact person	Dir. Prof. Jun Nishihira, M.D.
Organization	Hokkaido Information University
Division name	Health Information Science Center
Address	59-2, Nishi-nopporo, Ebetsu, 069-8585, Hokkaido
TEL	011-385-4430
Homepage URL
Email	nishihira@do-johodai.ac.jp

Sponsor
Institute	Hokkaido Information University
Institute
Department

Funding Source
Organization	Ministry of Agriculture, Forestry and Fisheries
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Hokkaido university faculty of agriculture National Agriculture and Food Research Organization for Hokkaido Region Kobayashi Foods co,Ltd.
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	北海総情報大学　保健センター（北海道）

Other administrative information
Date of disclosure of the study information	2014 Year 11 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 27 Day
Anticipated trial start date	2014 Year 12 Month 17 Day
Last follow-up date	2015 Year 04 Month 26 Day
Date of closure to data entry	2015 Year 08 Month 19 Day
Date trial data considered complete	2015 Year 08 Month 26 Day
Date analysis concluded	2016 Year 02 Month 02 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.sciencedirect.com/science/article/pii/S1756464616302122
Results
Other related information

Management information
Registered date	2014 Year 11 Month 13 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=R000018229