UMIN-CTR Clinical Trial

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
Email	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
Email	michio1@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044381