UMIN-CTR Clinical Trial

Public title

Double-blind, placebo-controlled study for the effect of rutin-rich processed buckwheat (Manten-kirari) on dyslipidemia and antioxidant

Acronym

Effect of rutin-rich buckwheat on dyslipidemia and antioxidant

Scientific Title

Double-blind, placebo-controlled study for the effect of rutin-rich processed buckwheat (Manten-kirari) on dyslipidemia and antioxidant

Scientific Title:Acronym

Effect of rutin-rich buckwheat on dyslipidemia and antioxidant

Region

Japan

Condition

dyslipidemia

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Prof. Jun Nishihira, M.D.

Organization

Hokkaido Information University

Division name

Department of Medical Management and Informatics

Zip code

Address

59-2, nishi-nopporo, ebetsu, 069-8585, Hokkaido

TEL

011-385-4411

Email

nishihira@do-johodai.ac.jp

Name of contact person

1st name
Middle name
Last name	Dir. Prof. Jun Nishihira, M.D.

Organization

Hokkaido Information University

Division name

Health Information Science Center

Zip code

Address

59-2, Nishi-nopporo, Ebetsu, 069-8585, Hokkaido

TEL

011-385-4430

Homepage URL

Email

nishihira@do-johodai.ac.jp

Institute

Hokkaido Information University

Institute

Department

Personal name

Organization

Ministry of Agriculture, Forestry and Fisheries

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

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)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北海総情報大学　保健センター（北海道）

Date of disclosure of the study information

2014

Year

11

Month

13

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.sciencedirect.com/science/article/pii/S1756464616302122

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

Recruitment status

Completed

Date of protocol fixation

2014

Year

10

Month

27

Day

Date of IRB

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

Other related information

Registered date

2014

Year

11

Month

13

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=R000018229