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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name