UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046219 |
|---|---|
| Receipt number | R000052748 |
| Scientific Title | Evaluation of the efficacy of beverage containing plant-derived components on postprandial blood lipids elevation |
| Date of disclosure of the study information | 2022/01/10 |
| Last modified on | 2023/02/02 13:56:48 |
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Basic information
Public title
Evaluation of the efficacy of beverage containing plant-derived components on postprandial blood lipids elevation
Acronym
The effect of beverage containing plant-derived components on postprandial blood lipid concentrations
Scientific Title
Evaluation of the efficacy of beverage containing plant-derived components on postprandial blood lipids elevation
Scientific Title:Acronym
The effect of beverage containing plant-derived components on postprandial blood lipid concentrations
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy of beverage containing plant-derived components on postprandial blood lipids elevation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood triglyceride levels, the peak value of blood triglyceride levels, delta blood triglyceride levels, delta Cmax (the peak value of delta blood triglyceride levels), IAUC (areas calculated based on the change of delta blood triglyceride levels)
Key secondary outcomes
Blood remnant like particles-cholesterol (RLP-C) levels, the peak value of blood RLP-C levels, delta blood RLP-C levels, delta Cmax (the peak value of delta blood RLP-C levels), IAUC (areas calculated based on the change of delta blood RLP-C levels)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Drinking placebo beverage with cream of corn soup (42 g of total fat)
Interventions/Control_2
Drinking beverage containing plant-derived components with cream of corn soup (42 g of total fat)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy adults (20 years or older) who do not get treatment or medication
2) Subjects who are normotriglyceridemia in previous medical check-ups
3) Subjects whose fasting blood triglyceride levels are not less than 30 mg/dL and less than 150 mg/dL in the screening test
4) Subjects who do not meet the key exclusion criteria
5) Subjects who are judged healthy by investigators
Key exclusion criteria
1) Subjects who have food allergy to the test meals
2) Subjects who can not eat cream of corn soup within scheduled time
3) Subjects who can not get their blood sampled as scheduled
4) Subjects who have remarkable hypersensitivity to alcohol
5) Subjects who will get pregnant or breast-feed during the study period
6) Subjects who join other human studies
7) Subjects who are judged unsuitable for this study by investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takuro |
| Middle name | |
| Last name | Inoue |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Takuro_Inoue@kagome.co.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo
TEL
03-3431-1260
Homepage URL
toya@huma-rd.co.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KAGOME CO., LTD.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
HUMA R&D CORP
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committees of NISHI-UMEDA Clinic for Asian Medical Collaboration
Address
3F Maruito Nishiumeda Build. 3-3-45 Umeda, Kita-ku, Osaka
Tel
06-4797-5660
jimukyoku@amc-clinc.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
医療法人共創会AMC西梅田クリニック(大阪府)（NISHI-UMEDA Clinic for Asian Medical Collaboration）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 10 | 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
Main results already published
Date of protocol fixation
| 2021 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 08 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 29 | Day |
Last modified on
| 2023 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052748
