UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051363 |
|---|---|
| Receipt number | R000058602 |
| Scientific Title | Evaluation of the efficacy of test food on LDL-cholesterol |
| Date of disclosure of the study information | 2023/06/19 |
| Last modified on | 2023/12/18 14:51:59 |
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Basic information
Public title
Evaluation of the efficacy of test food on LDL-cholesterol
Acronym
Evaluation of the efficacy of test food on LDL-cholesterol
Scientific Title
Evaluation of the efficacy of test food on LDL-cholesterol
Scientific Title:Acronym
Evaluation of the efficacy of test food on LDL-cholesterol
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 ingestion of test food on LDL-cholesterol comparing to placebo.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LDL-cholesterol at 12 weeks of ingestion.
Key secondary outcomes
1) Change in LDL-cholesterol at 12 weeks of ingestion.
2) Concentration of serum plant-derived component at 12 weeks of ingestion.
3) Change in concentration of serum plant-derived component at 12 weeks of ingestion.
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
Ingestion of placebo beverage for 12 weeks.
Interventions/Control_2
Ingestion of beverage containing plant-derived components 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. Healthy adults over 20 years old and under 65 years old.between 20 and 65 years old.
2. Subjects whose LDL-cholesterol less than 139 mg/dL based on Friedewald's equation in the pre-test.
3. Subjects who fully understand the purpose and content of the study and agree to participate in the study.
Key exclusion criteria
1. Subjects with dyslipidemia or familial hypercholesterolemia.
2. Subjects who have a disease under treatment or have a history of serious disease (dyslipidemia, diabetes, liver disease, renal disease, cardiac disease, psychiatric disease, etc.) that required medication treatment.
3. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc .
4. Subjects those who use health foods that may affect lifestyle-related diseases (blood lipid, blood pressure, blood glucose, uric acid levels).
5. Subjects who have had allergic reactions to drugs or foods especially test food.
6. Subjects who regularly take foods containing a large amount of plant-derived component.
7. Subjects who smoke excessive amounts of cigarettes on a daily basis (21 cigarettes/day or more).
8. Subjects who drink excessive amounts of alcohol on a daily basis (more than 20 g/day of pure alcohol equivalent three times or more per week).
9. Subjects who have an exercise habit (3 times a week or more) .
10. Subjects who are judged to be unsuitable for the study based on their responses to the screening questionnaire.
11. Subjects whose physical measurements, physical examination values, and clinical laboratory values on the pre-test are significantly out of the reference range.
12. Subjects who are participating in other clinical studies at the time this study is initiated.
13. Women who expected to be pregnant or lactating during this study.
14. Subjects who have irregular lifestyle such as shift workers, late night workers, etc.
15. Subjects who are judged unsuitable for this study by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Takahashi |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Shingo_Takahashi@kagome.co.jp
Public contact
Name of contact person
| 1st name | Keiji |
| Middle name | |
| Last name | Yamamoto |
Organization
EP Mediate Co., Ltd.
Division name
Foods Department, Trial Planning Section 1
Zip code
162-0821
Address
Kagurazaka AK Building, 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
070-3023-8214
Homepage URL
yamamoto.keiji799@eps.co.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
EP Mediate Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KAGOME Co.,LTD. Research Ethics Review Committee
Address
Nihonbashihamacho F Tower 3-21-1 Nihonbashih Hhamacho Chuou-ku, Tokyo
Tel
03-5623-8501
Takuji_Hayakawa@kagome.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
メディカルステーションクリニック （東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 19 | 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
| 2023 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 07 | 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 | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058602
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| Registered date | File name |
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