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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043673
Receipt No. R000049863
Scientific Title A Study on Lipid Improvement Effect of Food Containing Plant Extract -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Date of disclosure of the study information 2021/03/19
Last modified on 2021/10/01

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Basic information
Public title A Study on Lipid Improvement Effect of Food Containing Plant Extract
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym A Study on Lipid Improvement Effect of Food Containing Plant Extract
Scientific Title A Study on Lipid Improvement Effect of Food Containing Plant Extract
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym A Study on Lipid Improvement Effect of Food Containing Plant Extract
Region
Japan

Condition
Condition No
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the lipid improvement effect of food containing plant extract
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes LDL-cholesterol
Triglyceride
Key secondary outcomes Other lipid metabolism markers
Body fat and liver function markers

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 Foods containing plant extract, 12 weeks consumption
Interventions/Control_2 Foods not containing plant extract, 12 weeks consumption
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
65 years-old >
Gender Male and Female
Key inclusion criteria (1) Healthy males and females aged 20 to 64 years-old.
(2) Subjects whose LDL-cholesterol levels are 139 mg/dL or less, or triglyceride levels are 149 mg/dL or less by the screening tests.
(3) Subjects whose HDL-cholesterol levels are 40 mg/dL or over.
(4) Subjects whose BMI are under 30.
(5) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria (1) Subjects who use medications affecting obesity, hyperlipidemia, lipid metabolism.
(2) Subjects who contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease).
(3) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting obesity, hyperlipidemia, lipid metabolism.
(4) Subjects with tendency of diarrhea or who have diarrhea within 2 weeks before the screening test.
(5) Subjects who are shift workers and/or night-shift workers.
(6) Subjects who were pregnant or planned to become pregnant or breastfeed during the study period.
(7) Subjects who have been diagnosed as familial hyperlipidemia.
(8) Subjects with a history of and/or current drug addiction and/or alcoholism.
(9) Subjects who were planning to participate and/or had participated in other clinical studies within the month prior to the commencement of the current study.
(10) Subjects who were judged as unsuitable for the current study by the investigator for other reasons.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Masahiko
Middle name
Last name Tokushima
Organization Maebashi North Hospital
Division name Director
Zip code 371-0054
Address 692 Shimohosoi-machi,Maebashi-shi,Gunma
TEL 027-235-3333
Email sagawa@mc-connect.co.jp

Public contact
Name of contact person
1st name Yoshika
Middle name
Last name Komori
Organization KSO Corporation
Division name Sales department
Zip code 105-0023
Address 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email eigyou27@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization TOYO SHINYAKU Co., Ltd.
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 Ethical Committee of Kobuna Orthopedics Clinic
Address 5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel 027-212-5608
Email sagawa@mc-connect.co.jp

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
2021 Year 03 Month 19 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
2021 Year 03 Month 18 Day
Date of IRB
2021 Year 03 Month 18 Day
Anticipated trial start date
2021 Year 03 Month 22 Day
Last follow-up date
2021 Year 08 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 19 Day
Last modified on
2021 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049863

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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