UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053014 |
|---|---|
| Receipt number | R000060474 |
| Scientific Title | A study on the Cholesterol Reduction Effects of Krill Oil Intake - Double-blind, Placebo-Controlled, Randomized, Parallel Group Comparison Trial |
| Date of disclosure of the study information | 2023/12/14 |
| Last modified on | 2024/02/16 09:28:57 |
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Basic information
Public title
A study on the Cholesterol Reduction Effects of Krill Oil Intake - Double-blind, Placebo-Controlled, Randomized, Parallel Group Comparison Trial
Acronym
A study on the Cholesterol Reduction Effects of Krill Oil Intake
Scientific Title
A study on the Cholesterol Reduction Effects of Krill Oil Intake - Double-blind, Placebo-Controlled, Randomized, Parallel Group Comparison Trial
Scientific Title:Acronym
A study on the Cholesterol Reduction Effects of Krill Oil Intake
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the effects of a research food on blood cholesterol levels and related lipid parameters in individuals aged between 20 and 75, with LDL-C levels of 120mg/dL or more but less than 180mg/dL, and T-Cho levels of 200mg/dL or more, over a period of 12 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LDL-C, T-Cho
Key secondary outcomes
TG, HDL-C, Non-HDL-C, NEFA, Apolipoprotein A1, Apolipoprotein B, atherosclerosis index, Body weight, BMI, Blood fatty acids
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
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will take one capsule of the control food twice daily, after breakfast and dinner, with water or warm water.
Interventions/Control_2
Participants will also take one capsule of the test food twice daily, after breakfast and dinner, with water or warm water.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age: Between 20 and 75
2. Gender: Japanese men and women
3. LDL-C levels of 120mg/dL or more but less than 180mg/dL and T-Cho levels of 200mg/dL or more at SCR (Visit 1)
4. Capability of inputting electronic diary via smartphone or PC
5. Individuals who have been given a comprehensive explanation about the purpose and content of the study, fully understand it, voluntarily agree to participate, and provide written consent to participate in the study.
Key exclusion criteria
1.have had medical treatment for any disease or have been on any other drugs and Kampo medicines in the past 6 months.
2.have a current or past history of clinically significant acute or chronic diseases requiring acute or chronic treatment in various body systems including cardiovascular, endocrine, immune, respiratory, hepatobiliary, renal and urinary, neuropsychiatric, musculoskeletal, inflammatory, hematologic and tumoral, and gastrointestinal diseases, or systemic infectious diseases.
3.have undergone antipsychotic drug treatment in the past 3 months.
4.Those undergoing diet or exercise therapy under the supervision of a physician.
5.current or past history of serious diseases other than those mentioned in 2.
6.currently taking medicines, quasi-drugs, FOSHU, FFC, health foods, or supplements that may affect weight, blood triglycerides, or cholesterol levels.
7.currently taking drugs or foods other than those mentioned in 6, at least three times a week. However, those who can stop taking them after obtaining consent can participate.
8.AST or ALT levels more than three times the upper limit of the standard at visit 1.
9.serum creatinine levels of 2.0mg/dL or more at visit 1.
10.have a current or past history of drug or food allergies.
11.have a past history of significant hypersensitivity to krill oil components.
12.planning to make major changes to their lifestyle habits during the trial period.
13.planning to travel overseas during the trial period.
14.pregnant, lactating, or wishing to become pregnant during the trial period.
15.shift workers.
16.have a past history of alcohol addiction or drug abuse.
17.heavy drinkers (40g or more of alcohol/day).
18.heavy smokers (more than 21 cigarettes/day).
19.have participated in other clinical trials within one month prior to obtaining consent, are currently participating, or plan to participate during the trial period.
20.Those deemed unsuitable for participation in this study by the principal investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Higashikoganei-sakura clinic
Division name
Head doctor
Zip code
184-0011
Address
4-37-26 Higashicho Koganei-shi Tokyo Japan
TEL
03-6704-5968
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
Daiwa Ginza Bld. 3F, 6-2-1, Ginza, Chuo-ku, Tokyo, Japan
TEL
0367045968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
NUTRIONE CO.,LTD
Institute
Department
Personal name
Funding Source
Organization
NUTRIONE 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
0367045968
n-yuzawa@imeqrd.co.jp
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 14 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 06 | Day |
Last modified on
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060474
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