UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047717 |
|---|---|
| Receipt number | R000054406 |
| Scientific Title | A verification study of the reduction effect of LDL cholesterol by the test food consumption in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2022/05/11 |
| Last modified on | 2024/03/14 11:34:49 |
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Basic information
Public title
A verification study of the reduction effect of LDL cholesterol
Acronym
A verification study of the reduction effect of LDL cholesterol
Scientific Title
A verification study of the reduction effect of LDL cholesterol by the test food consumption in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
A verification study of the reduction effect of LDL cholesterol by the test food consumption in healthy Japanese subjects
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the reduction effect of LDL cholesterol by the test food consumption in healthy Japanese subjects
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. LDL cholesterol at 12 weeks after consumption (12w)
Key secondary outcomes
1. LDL cholesterol at four and eight weeks after consumption (4w, 8w)
2. The ratio of subjects within each group whose LDL cholesterol is less than 120 mg/dL at 12w
3. Total cholesterol, non HDL cholesterol, HDL cholesterol, the ratio of LDL cholesterol per HDL cholesterol, and triglyceride (TG)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test beverage: Beverage containing dietary fiber
Administration: In principle, dissolve one packet of the powder test food with 180 mL of water and drink it 15 minutes before each meal (breakfast, lunch, and dinner). Open the powder test food immediately before drinking it. If you reluctantly can not drink the test beverage 15 minutes before each meal, drink it until immediately before each meal.
Interventions/Control_2
Duration: 12 weeks
Test beverage: Placebo beverage
Administration: In principle, dissolve one packet of the powder test food with 180 mL of water and drink it 15 minutes before each meal (breakfast, lunch, and dinner). Open the powder test food immediately before drinking it. If you reluctantly can not drink the test beverage 15 minutes before each meal, drink it until immediately before each meal.
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. Japanese
2. Men or women
3. Subjects aged 20 or more and less than 65
4. Healthy subjects
5. Subjects who have breakfast, lunch, and dinner every day
6. Subjects who are judged as eligible to participate in the study by the physician
7. Subjects whose fasting TG level is less than 400 mg/dL
8. Subjects whose BMI is 18.5 or more and less than 30 at screening (before consumption; Scr)
9. Subjects whose LDL cholesterol is between 120 mg/dL and 139 mg/dL at Scr
Key exclusion criteria
Subjects
1. who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use
5. currently taking medicines (include herbal medicines) and supplements
6. who are allergic to medications and/or the test-beverage-related products
7. who have a surgical history of either gastrointestinal disease influencing digestion and absorption or digestive organ, or current history of disorder such as stricture in digestive organ
8. who tend to have diarrhea or constipation on daily
9. who have a pre-existing or present condition of drug or alcohol dependence
10. whose daily average number of smoking cigarettes is 21 or more
11. whose daily average amount of drinking as pure alcohol is over 60 g
12. who are shift workers or late-night shift workers
13. who are pregnant, lactation, or planning to become pregnant
14. who suffer from COVID-19
15. who cannot prepare the test beverages according to pre-decided instructions and take them three times when eating each diet a day
16. who are collected blood or donated blood components either 200 mL within 28 days or over 400 mL within three months before the agreement to participate in this trial
17. who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
18. who are judged as ineligible to participate in the study by the physician
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
NISSIN FOODS HOLDINGS CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
IRB@takara-clinic.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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 11 | 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
56
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
| 2022 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 11 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054406
