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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047717
Receipt No. 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 2022/05/11

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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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

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
Email 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
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 Open public recruiting
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
2022 Year 05 Month 11 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054406

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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