UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040863 |
|---|---|
| Receipt number | R000044381 |
| Scientific Title | The effects of a combination agent of perilla oil and natural product-derived functional substrates on body composition, hematological and biological blood parameters in the elderly |
| Date of disclosure of the study information | 2020/06/23 |
| Last modified on | 2021/04/15 15:14:42 |
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Basic information
Public title
The effects of a combination agent of perilla oil and natural product-derived functional substrates on body composition, hematological and biological blood parameters in the elderly
Acronym
The effects of a combination agent of perilla oil and natural product-derived functional substrates on body composition, hematological and biological blood parameters in the elderly
Scientific Title
The effects of a combination agent of perilla oil and natural product-derived functional substrates on body composition, hematological and biological blood parameters in the elderly
Scientific Title:Acronym
The effects of a combination agent of perilla oil and natural product-derived functional substrates on body composition, hematological and biological blood parameters in the elderly
Region
| Japan |
Condition
Condition
The adult and elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Soft capsules containing perilla oil containing 60% of alpha-linolenic acid, an omega-3 fatty acid, and AD blue poncan powder containing 0.28% of nobiletin or Anredera cordifolia leaf dry powder, which is a functional substance derived from natural products. The main purpose of this study is to examine the effects of chronic administration of these soft capsules on the safety and the health of the adult and elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood biochemical items, Health condition
Key secondary outcomes
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Perilla oil
Interventions/Control_2
12 months
Interventions/Control_3
capsules
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
. The age at consent 40 years old over and 85 years old or younger.
. The cognitive function test value at the start of the test satisfies all of the following.
Total MMSE score is 22 points or more.
Total HDS-R scores is 21 points or more.
. Agreement has been obtained from the principal concerning research participation in writing.
. Conversation in Japanese is possible.
Key exclusion criteria
.Development of dementia and osteoporosis.
.Use a antipsychotics, dementia treatment drugs, anticoagulants and antiplatelet drugs.
. Taking drugs containing linolenic acid, EPA and/or DHA, and supplements that expected to improve brain function and serum lipid levels.
.Taking osteoporosis remedies and supplements that are expected to improve bones.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Hashimoto |
Organization
Shimane University
Division name
Faculty of Medicine, Department of Environmental Physiology
Zip code
693-8501
Address
89-1, Enyacho, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2730
michio1@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Hashimoto |
Organization
Shimane University
Division name
Faculty of Medicine, Department of Environmental Physiology
Zip code
693-8501
Address
89-1, Enyacho, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2730
Homepage URL
michio1@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Sankyo Holdings 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
Shiamne University
Address
89-1 Enyachou, Izumo, Shimane 693-8501, Japan
Tel
0853-20-2730
michio1@med.shimane-u.ac.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
| 2020 | Year | 06 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
102
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
| 2018 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 02 | Month | 20 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 23 | Day |
Last modified on
| 2021 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044381
