UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of astaxanthin on cognitive and physical function A randomized, double blind, placebo-controlled study
Title of the study (Brief title)	The effect of astaxanthin on cognitive and physical function
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the influence on cognitive ability and physical function by continuous ingestion of astaxanthin-containing capsules.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognitive function test, Physical function test
Key secondary outcomes	Feeling questionnaire

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	Study food 12weeks
Interventions/Control_2	Placebo 12weeks
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	60 years-old <=
Age-upper limit	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Healthy males and females aged 60 to 79 years old 2) Subjects who are aware of declining cognitive ability 3) Subjects who have 24 points or more on MMSE score 4) Subjects who are aware of declining physical strength
Key exclusion criteria	1) Subjects with dementia (including Alzhheimer type dementia) 2) Subjects who have symptoms of mild cognitive impairment (MCI) 3) Subjects who had treatment, hospitalization, and/or surgery due to Stroke, Subarachnoid hemorrhage, Cerebral infarction, Cerebral hemorrhage, Brain contusion, and/or Head trauma 4) Subjects with chronic or acute infection 5) Subjects who have current disease or history of hepatitis 6) Subjects who are attending a hospital by following diseases or has medical history of Attack, Seizures, Diabetes, Thyroid dysfunction, Blood dialysis, Uremia, Anuria, Inner ear disease (Meniere's disease and so on), and/or Asthma 7) Subjects with medical history of serious disorder (Liver disease, Kidney disease, Hypertension, Ischemic heart disease, Impaired glucose tolerance, Gastrointestinal disease, Peripheral vascular disease, and so on) 8) Subjects with Cardiorespiratory disorder 9) Subjects who have abnormal test value in liver function and kidney function 10) Subjects who have undergone surgery of the gastrointestinal tract 11) Subjects with food, drug allergy 12) Subjects who have received the neuropsychological tests in hospital 13) Subjects with movement disorders, visual impairment, hearing impairment 14) Subjects who have experience to feel sick by watching shiny light 15) Subjects on a diet 16) Subjects with excessive smoking habit 17) Subjects who ingested in excessive alcohol or cannot abstain from alcohol from the day before the study to the day of study 18) Subjects who take healthy foods, quasi-drugs and pharmaceuticals (including OTC, prescription medicine) containing ingredients contained in the test food 19) Subjects participating in other clinical trials at the start of the present study 20) Subjects who the investigator deems inappropriate
Target sample size	40

Research contact person
Name of lead principal investigator	Naoki Miura
Organization	Miura Clinic, Medical Corporation Kanonkai
Division name	Internal medicine
Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	06-6135-5200
Email	info@miura-cl.jp

Public contact
Name of contact person	Makoto Terashima
Organization	Oneness support Co., Ltd.
Division name	Clinical trial Division
Address	Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	06-4801-8917
Homepage URL
Email	mterashima@oneness-sup.co.jp

Sponsor
Institute	Miura Clinic, Medical Corporation Kanonkai
Institute
Department

Funding Source
Organization	AstaReal Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 08 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 17 Day
Anticipated trial start date	2017 Year 09 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 22 Day
Last modified on	2018 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032927