UMIN-CTR Clinical Trial

Public title

The effect of astaxanthin on cognitive and physical function
A randomized, double blind, placebo-controlled study

Acronym

The effect of astaxanthin on cognitive and physical function

Scientific Title

The effect of astaxanthin on cognitive and physical function
A randomized, double blind, placebo-controlled study

Scientific Title:Acronym

The effect of astaxanthin on cognitive and physical function

Region

Japan

Condition

Healthy volunteer

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Cognitive function test, Physical function test

Key secondary outcomes

Feeling questionnaire

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Naoki Miura

Organization

Miura Clinic, Medical Corporation Kanonkai

Division name

Internal medicine

Zip code

Address

Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka

TEL

06-6135-5200

Email

info@miura-cl.jp

Name of contact person

1st name
Middle name
Last name	Makoto Terashima

Organization

Oneness support Co., Ltd.

Division name

Clinical trial Division

Zip code

Address

Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka

TEL

06-4801-8917

Homepage URL

Email

mterashima@oneness-sup.co.jp

Institute

Miura Clinic, Medical Corporation Kanonkai

Institute

Department

Personal name

Organization

AstaReal Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

08

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

08

Month

17

Day

Date of IRB

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

Other related information

Registered date

2017

Year

08

Month

22

Day

Last modified on

2018

Year

07

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032927