UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of cholesterol reduction effect by ingesting concentrated red malt
Title of the study (Brief title)	Evaluation of cholesterol reduction effect by ingesting supplement.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A placebo-controlled double-blind study was conducted to evaluate the effect of cholesterol reduction by ingesting concentrated red malt. We performed physical measurement, doctor's findings and evaluations, dietary advice, qualification judgment by doctor, health diary, height measurement, blood test, measurement of blood pressure and pulse, diet survey and lifestyle survey.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood test(LDL cholesterol)
Key secondary outcomes	Measurement of blood pressure and pulse Blood test Diet survey Doctor's findings and evaluations Dietary advice Physical measurement Health diary

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Test 2 capsules once once a day after dinner with water
Interventions/Control_2	Placebo 2 capsules once once a day after dinner with water
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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Japanese males and females aged 30 to 59 years old at the time of acquiring consent on the first observation day (equal males and females) 2) Persons who have increased serum cholesterol
Key exclusion criteria	1) Persons who are taking medications (lipid-lowering drugs, etc.) that are likely to affect the test results 2) Persons routinely taking health foods (supplements with cholesterol-reducing effect, etc.) that are likely to affect the test results 3) Alcohol addiction 4) Persons who are likely to have allergic symptoms depending on the test article component 5) Participating in other clinical trials 6) Persons who have a history of serious liver disorder, kidney disorder, heart disease 7) Persons who have a history of hepatitis or who are currently suffering from hepatitis 8) Persons with serious anemia 9) Persons who are judged inappropriate to participate the study by the supervising doctor (When recognizing the fact that it is determined to be ineligible during the course of the test, it is excluded from the analysis subject. Note that inspection items that are not screening criteria are not an exclusion criterion from screening.)
Target sample size	30

Research contact person
Name of lead principal investigator	Takashi Koikeda
Organization	Shiba Palace Clinic
Division name	Chair
Address	6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL	03-5408-1590
Email	jimukyoku@mail.souken-r.com

Public contact
Name of contact person	Ko Masuda
Organization	SOUKEN Co., Ltd
Division name	Management Division
Address	3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL	03-5408-1555
Homepage URL
Email	k_masuda@mail.souken-r.com

Sponsor
Institute	Shiba Palace Clinic
Institute
Department

Funding Source
Organization	DHC Corporation.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 04 Day
Anticipated trial start date	2017 Year 10 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 26 Day
Last modified on	2018 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033967