UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021893 |
|---|---|
| Receipt number | 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 21:01:25 |
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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
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
a.muto3@kurenai.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025244
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
