UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032847
Receipt number R000037451
Scientific Title Effects of cognicise (combined physical and cognitive exercises) and chlorella intake for prevention from dementia in elderly people.
Date of disclosure of the study information 2018/06/03
Last modified on 2020/03/10 14:04:27

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Basic information

Public title

Effects of cognicise (combined physical and cognitive exercises) and chlorella intake for prevention from dementia in elderly people.

Acronym

Effects of cognicise and chlorella intake for prevention from dementia.

Scientific Title

Effects of cognicise (combined physical and cognitive exercises) and chlorella intake for prevention from dementia in elderly people.

Scientific Title:Acronym

Effects of cognicise and chlorella intake for prevention from dementia.

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this trial is to investigate effects of cognicise (combined physical and cognitive exercises) and chlorella intake for prevention from dementia in elderly people.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

cognitive function evaluation

Key secondary outcomes

Metabolome analysis of human blood


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

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 Behavior,custom

Interventions/Control_1

Test group
Oral intake of tablets with 8g Chlorella extract twice a day after breakfast and supper for 6 months.
Combined physical and cognitive exercises

Interventions/Control_2

Control group
Oral intake of tablets without Chlorella extract twice a day after breakfast and supper for 6 months.
Combined physical and cognitive exercises

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

65 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy Japanese men and women ages from 65 to 90 years old.

Key exclusion criteria

1)oral anticoagulants in patients
2)dementia

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kojiro
Middle name
Last name Ishii

Organization

Doshisha University

Division name

Faculty of Health & Sports Science

Zip code

610-0394

Address

1-3 Tatara Miyakodani, Kyotanabe City, Kyoto

TEL

0774-65-6724

Email

kishii@mail.doshisha.ac.jp


Public contact

Name of contact person

1st name Kojiro
Middle name
Last name Ishii

Organization

Doshisha University

Division name

Faculty of Health & Sports Science

Zip code

610-0394

Address

1-3 Tatara Miyakodani, Kyotanabe City, Kyoto

TEL

0774-65-6724

Homepage URL


Email

kishii@mail.doshisha.ac.jp


Sponsor or person

Institute

Doshisha University

Institute

Department

Personal name



Funding Source

Organization

Sun Chlorella Corp.

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

Doshisha University Office of Ethics Review

Address

Karasuma-higashi-iru, Imadegawa-dori, Kamigyo-ku, Kyoto-shi 602-8580

Tel

075-251-3158

Email

ji-rinri@mail.doshisha.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

2018 Year 06 Month 03 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

14

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 06 Month 21 Day

Date of IRB

2018 Year 05 Month 30 Day

Anticipated trial start date

2018 Year 06 Month 21 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 06 Month 02 Day

Last modified on

2020 Year 03 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037451


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name