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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021893
Receipt No. R000025244
Scientific Title The effect of timing of exercise with olive fruit extract intake on cognitive performance and motor functions in the elderly: a randomized, double-blind and placebo-controlled trial.
Date of disclosure of the study information 2016/04/13
Last modified on 2018/06/11

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Basic information
Public title The effect of timing of exercise with olive fruit extract intake on cognitive performance and motor functions in the elderly: a randomized, double-blind and placebo-controlled trial.
Acronym The effect of timing of exercise with olive fruit extract intake on cognitive performance and motor functions in the elderly
Scientific Title The effect of timing of exercise with olive fruit extract intake on cognitive performance and motor functions in the elderly: a randomized, double-blind and placebo-controlled trial.
Scientific Title:Acronym The effect of timing of exercise with olive fruit extract intake on cognitive performance and motor functions in the elderly
Region
Japan

Condition
Condition Elderly
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of timing of exercise with/without olive fruit extract intake on cognitive performance and motor functions in the elderly.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes body composition
Key secondary outcomes Motor functions, Japanese Knee Osteoarthritis Measure(JKOM score), psychological parameters, , blood pressure, cognitive performance, Pittsburgh Quality of Sleep Index (PSQI-J)

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food Behavior,custom
Interventions/Control_1 Morning exercise and olive fruit extracts supplementation for 3 months
Interventions/Control_2 Morning exercise and olive fruit extracts placebo for 3 months
Interventions/Control_3 Afternoon exercise and olive fruit extracts supplementation for 3 months
Interventions/Control_4 Afternoon exercise and olive fruit extracts placebo for 3 months
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Age>=65 years
2) Receiving care1~2 authorization in the Long-Term Care Insurance Law
3) Informed consent provided
4) Able to receive and take experimental supplements
5) Able to follow the instructions of the study team
Key exclusion criteria 1) Disease that exercise is prohibited by medical doctor
2) Allergy against olive fruit extracts using in this study
3) Subjects judged by the investigator/project leader to be ineligible for other reasons
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shibenobu Shibata
Organization Waseda University
Division name Faculty of Science and Engineering
Zip code
Address 2-2, Wakamatsu-cho,Shinjyuku,Tokyo,162-8480,Japan
TEL 03-5369-7318
Email shibatas@waseda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aya Muto
Organization Waseda University
Division name Faculty of Science and Engineering
Zip code
Address 2-2, Wakamatsu-cho,Shinjyuku,Tokyo,162-8480,Japan
TEL 03-5369-7318
Homepage URL
Email a.muto3@kurenai.waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization Japanese Council for Science, Technology and Innovation (CSTI),
Cross-ministerial Strategic Innovation Promotion Program
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 13 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 13 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 13 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 04 Month 13 Day
Last modified on
2018 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025244

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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