UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044228 |
|---|---|
| Receipt number | 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 | 2023/11/17 15:03:56 |
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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
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
Primary outcomes
HDL-cholesterol level
Key secondary outcomes
Total cholesterol level, LDL-cholesterol level, triglyceride level, serum active ingredient level, skin carotenoid level
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
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
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
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. 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
Takuro_Inoue@kagome.co.jp
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
imai@levbrain.com
Sponsor or person
Institute
Leverage Brain Inc.
Institute
Department
Personal name
Funding Source
Organization
KAGOME 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
Japan Conference of Clinical Research
Address
1-13-23 Minamiikebukuro, Toshima-ku, Tokyo, Japan
Tel
03-6868-7022
jccr-info@cts-smo.com
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 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
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 | 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
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 17 | Day |
Last modified on
| 2023 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050511
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