UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022299
Receipt number R000025682
Scientific Title Efficacy study of oral astaxanthin to improve brain function for the middle aged and elderly
Date of disclosure of the study information 2016/05/15
Last modified on 2016/11/08 15:42:30

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Basic information

Public title

Efficacy study of oral astaxanthin to improve brain function for the middle aged and elderly

Acronym

Efficacy study of oral astaxanthin to improve brain function

Scientific Title

Efficacy study of oral astaxanthin to improve brain function for the middle aged and elderly

Scientific Title:Acronym

Efficacy study of oral astaxanthin to improve brain function

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare and evaluate the effect of a test food on brain function before and after ingestion of the test food or placebo

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Memory test of words, Recall test of words and Stroop test

Key secondary outcomes

POMS
VAS for fatigue
Action of the bowels
Serum concentration of astaxanthin


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

Prevention

Type of intervention

Food

Interventions/Control_1

The treatment group will receive oral administration of two jellies including 2 mg astaxanthin twice daily (8 mg astaxanthin/ 4 jellies /day) for 8 consecutive weeks.

Interventions/Control_2

The placebo group will receive oral administration of two astaxanthin-free jellies twice daily (4 jellies /day) for 8 consecutive 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

45 years-old <=

Age-upper limit

64 years-old >=

Gender

Male and Female

Key inclusion criteria

Age at the time of giving informed consent: 45 to 64 years

Key exclusion criteria

(1) Subjects who are difficult to discriminate color
(2) Subjects with bad eyesight, or are diagnosed with amblyopia or blindness
(3) Subjects with bad hearing, or are diagnosed with hearing loss or permanent hearing loss
(4) Subjects who get a score of 20 or less on the Revised HDS-R
(5) Subjects who smoke, or quit smoking within one year before pre-inspection
(6) Subjects with history of cranial nerve disease
(7) Subjects with depressive symptoms or history of them
(8) Subjects who are under hormone treatment or are diagnosed with menopause
(9) Subjects who have some irregular schedules during the study, due to night work or something
(10) Subjects who drink much alcohol
(11) Subjects who have done brain function test before
(12) Subjects who are under treatment of brain function, sleep or stress, or are prescribed with medicine for them
(13) Subjects who continuously take medicine, health foods, Food for Specified Health Uses or Foods with Function Claims including substance related to brain function, antioxidant, sleep or stress
(14) Subjects who was given or donated 200 ml or 400 ml whole blood within three months before pre-inspection
(15) Subjects who participated in other study within one month before pre-inspection, or are going to participate in other study during the study
(16) Subjects who have a disease which needs regular medication, or have a history of the disease
(17) Subjects who are judged as unsuitable for the study by investigator because of clinical test, anthropometric test and physical examination in pre-inspection
(18) Subjects who are in danger of allergy to the ingredients of the test food
(19) Subjects who are pregnant or lactating, or plan to become pregnant or lactate during the study
(20) Subjects who are judged as unsuitable for the study because of lifestyle questionnaire
(21) Subjects who are judged as unsuitable for the study by investigator for other reasons

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Ishibashi

Organization

JX Nippon Oil & energy Corporation

Division name

Biotechnology Business Group Biotechnology Business Unit Specialty Chemicals & Materials Company

Zip code


Address

1-2, Otemachi 1-chome, Chiyoda-ku Tokyo

TEL

03-6257-6826

Email

ishibashi.takashi@jxgr.com


Public contact

Name of contact person

1st name
Middle name
Last name Masahiro Hayashi

Organization

JX Nippon Oil & energy Corporation

Division name

Biotechnology Business Group Biotechnology Business Unit Specialty Chemicals & Materials Company

Zip code


Address

1-2, Otemachi 1-chome, Chiyoda-ku Tokyo

TEL

03-6257-4559

Homepage URL


Email

hayashi.masahiro@jxgr.com


Sponsor or person

Institute

JX Nippon Oil & energy Corporation

Institute

Department

Personal name



Funding Source

Organization

JX Nippon Oil & energy 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


Address


Tel


Email



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

医療法人健昌会 福島健康管理センター(大阪府)
いきいきクリニック(大阪府)


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 15 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


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

2016 Year 04 Month 21 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 16 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 13 Day

Last modified on

2016 Year 11 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025682


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name