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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023894
Receipt No. R000027521
Scientific Title The verification study for blood lipid reduction effects: a randomized, double-blind, controlled trial
Date of disclosure of the study information 2016/09/01
Last modified on 2017/05/02

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Basic information
Public title The verification study for blood lipid reduction effects: a randomized, double-blind, controlled trial
Acronym The verification study for blood lipid reduction effects
Scientific Title The verification study for blood lipid reduction effects: a randomized, double-blind, controlled trial
Scientific Title:Acronym The verification study for blood lipid reduction effects
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the LDL-cholesterol reduction effects due to the ingestion of the test material.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1. LDL-cholesterol
*1 Take the blood samples at 0 week and 12 weeks after the ingestion
Key secondary outcomes 1. Total cholesterol, HDL-cholesterol, LDL/HDL ratio, triglyceride (TG), glucose, HbA1c, and glycoalbumin
*1 Take the blood samples at 0 week and 12 weeks after the ingestion

2. Body weight, BMI, and body fat percentage
*2 Take the measurements at 0 week and 12 weeks after the ingestion

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 Duration: 12 weeks
Test material: "health beverage"
Administration: Drink it at any time of a day
Interventions/Control_2 Duration: 12 weeks
Test material: "Placebo beverage"
Administration: Drink it at any time of a day
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Healthy Japanese adults of 20 years old or more

2. LDL-cholesterol levels were higher in the boundary region at most recent medical check-up
Key exclusion criteria 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction

2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases

3. Currently taking medicines and/or herbal medicines

4. Those who eat Food with Functional Claims of the LDL-cholesterol reduction effects and drink beverage with related to vinegar on a daily basis

5. Those who eat and/or drink Food for Specified Health Uses and/or Food with Function Claims on a daily basis

6. Allergic to medicines or foods related to the test food of this trial

7. Pregnant, lactating, or planning to get pregnant during the trial period

8. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial

9. Judged unsuitable for participating in this trial by physician
Target sample size 14

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO, Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO, Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO, Inc.
Institute
Department

Funding Source
Organization Fukuyama Kurozu Inc..
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Seishin-kai Medical Association Inc, Takara Medical Clinic.
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 医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 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
2016 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 02 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
2016 Year 09 Month 01 Day
Last modified on
2017 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027521

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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