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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044228
Receipt No. R000050511
Scientific Title Effect of daily ingestion of the test drink on HDL-cholesterol level
Date of disclosure of the study information 2021/06/30
Last modified on 2021/05/17

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Basic information
Public title Effect of daily ingestion of the test drink on HDL-cholesterol level: A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Comparison Study
Acronym Effect of daily ingestion of the test drink on HDL-cholesterol level
Scientific Title Effect of daily ingestion of the test drink on HDL-cholesterol level
Scientific Title:Acronym Effect of daily ingestion of the test drink on HDL-cholesterol level

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

Narrative objectives1 To assess the effect of intake of test drink on HDL-cholesterol level comparing to placebo drink.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Primary outcomes HDL-cholesterol level
Key secondary outcomes Total cholesterol level, LDL-cholesterol level, triglyceride level, serum active ingredient level, skin carotenoid level

Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Dynamic allocation
Institution consideration
Blocking YES
Concealment No need to know

No. of arms 2
Purpose of intervention Prevention
Type of intervention
Interventions/Control_1 Daily ingestion of 200 mL of juice containing active ingredient for 12 weeks
Interventions/Control_2 Daily ingestion of 200 mL of juice not containing active ingredient for 12 weeks

Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Subjects who agree to participate in this study with a written informed consent
2. Subjects whose HDL-cholesterol level is >=35 mg/dL and <=60 mg/dL
Key exclusion criteria 1. Subjects who are under physician's advice, treatment, and/or medication for dyslipidemia and/or diabetes.
2. Subjects with familial hypercholesterolemia.
3. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
4. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
5. Subjects who have had allergic reactions to drugs or foods especially based on test food, Japanese cedar, Japanese cypress, or grass.
6. Subjects who regularly use medicines, health foods, and supplements.
7. Subjects who regularly take foods containing ingredients of test food.
8. Heavy smokers.
9. Alcohol addicts.
10. Subjects with disordered lifestyle.
11. Subjects with anemia.
12. Pre- or post-menopausal women complaining of obvious physical changes.
13. Pregnant or lactating women, women who expect to be pregnant during this study or may be pregnant.
14. Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study.
15. Subjects who regularly exercise.
16. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size 270

Research contact person
Name of lead principal investigator
1st name Takuro
Middle name
Last name Inoue
Organization KAGOME CO., LTD.
Division name Innovation Division
Zip code 329-2762
Address 17 Nishitomiyama, Nasushiobara-shi, Tochigi, Japan
TEL 0287-36-2935

Public contact
Name of contact person
1st name Shigeru
Middle name
Last name Imai
Organization Leverage Brain Inc.
Division name Clinical Trial Department
Zip code 105-0004
Address 2-16-1 Shinbashi, Minato-ku, Tokyo, Japan
TEL 080-7290-0404
Homepage URL

Institute Leverage Brain Inc.

Funding Source
Organization KAGOME CO.,LTD.
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japan Conference of Clinical Research
Address 1-13-23 Minamiikebukuro, Toshima-ku, Tokyo, Japan
Tel 03-6868-7022

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2

Institutions 医療法人社団 知正会 東京センタークリニック

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

URL related to results and publications
Number of participants that the trial has enrolled
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 Preinitiation
Date of protocol fixation
2021 Year 04 Month 23 Day
Date of IRB
2021 Year 05 Month 13 Day
Anticipated trial start date
2021 Year 07 Month 01 Day
Last follow-up date
2021 Year 12 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other related information

Management information
Registered date
2021 Year 05 Month 17 Day
Last modified on
2021 Year 05 Month 17 Day

Link to view the page

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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