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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029727
Receipt No. R000033967
Scientific Title Evaluation of cholesterol reduction effect by ingesting concentrated red malt
Date of disclosure of the study information 2017/10/27
Last modified on 2018/12/26

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Basic information
Public title Evaluation of cholesterol reduction effect by ingesting concentrated red malt
Acronym Evaluation of cholesterol reduction effect by ingesting supplement.
Scientific Title Evaluation of cholesterol reduction effect by ingesting concentrated red malt
Scientific Title:Acronym 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
1st name
Middle name
Last name Takashi Koikeda
Organization Shiba Palace Clinic
Division name Chair
Zip code
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
1st name
Middle name
Last name Ko Masuda
Organization SOUKEN Co., Ltd
Division name Management Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2017 Year 09 Month 04 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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