UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043279 |
|---|---|
| Receipt number | R000049402 |
| Scientific Title | Effect of the combined ingestion of plant-derived ingredients on the serum triglyceride levels |
| Date of disclosure of the study information | 2021/02/08 |
| Last modified on | 2021/02/08 15:01:48 |
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Basic information
Public title
Effect of the combined ingestion of plant-derived ingredients on the serum triglyceride levels
Acronym
Effect of the combined ingestion of plant-derived ingredients on the serum triglyceride levels
Scientific Title
Effect of the combined ingestion of plant-derived ingredients on the serum triglyceride levels
Scientific Title:Acronym
Effect of the combined ingestion of plant-derived ingredients on the serum triglyceride levels
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the TG-lowering effect of the ingredients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the fasting serum TG level after 4 weeks of daily ingestion of ingredients
Key secondary outcomes
Evaluation of the lipid profile after 4 weeks of daily ingestion of ingredients
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
continuous ingestion of the placebo beverage for 4 weeks
Interventions/Control_2
continuous ingestion of the test beverage for 4 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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy males and postmenopausal females
TG <= 120mg/dL and >= 200mg/dL in screening
Key exclusion criteria
1) under treatment for severe disease
2) history of or under treatment for gastrointestinal disorder
3) taking therapeutic medicine
4) taking functional food for lipid management.
5) heavy drinker and smoker
6) Subjects who have been to get sick by collecting venous blood
7) food allergy
8) Subjects who are planned to participate in other clinical study during current study.
9) Subjects who are judged to be inappropriate for the study by the medical doctor
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Hibi |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
31-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, Japan
TEL
+81-3-5630-7266
hibi.masanobu@kao.com
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Matsui |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
31-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, Japan
TEL
+81-3-5630-7266
Homepage URL
matsui.yuji@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Utsukushigaoka Hospital
Address
61-1, Mae, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan
Tel
011-882-0111
matsuda@ughp-cpc.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
医療法人北武会美しが丘病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 08 | 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
36
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
| 2017 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 08 | Day |
Last modified on
| 2021 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049402
