UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Shibenobu Shibata
Organization	Waseda University
Division name	Faculty of Science and Engineering
Address	2-2, Wakamatsu-cho,Shinjyuku,Tokyo,162-8480,Japan
TEL	03-5369-7318
Email	shibatas@waseda.jp

Public contact
Name of contact person	Aya Muto
Organization	Waseda University
Division name	Faculty of Science and Engineering
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000025244