UMIN-CTR Clinical Trial

Basic information
Public title	Trial of the efficacy of exercise and food ingredients on cognitive function in elderly.
Acronym	Trial of the efficacy of exercise and food ingredients on cognitive function in elderly.
Scientific Title	Trial of the efficacy of exercise and food ingredients on cognitive function in elderly.
Scientific Title:Acronym	Trial of the efficacy of exercise and food ingredients on cognitive function in elderly.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of exercise and food ingredients on cognitive function in elderly.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Score of a neuropsychological test at 0 week and 24 weeks after the intervention.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food Behavior,custom
Interventions/Control_1	Exercise and supplements containing food ingredients for 24 weeks
Interventions/Control_2	Exercise and supplements not containing food ingredients for 24 weeks
Interventions/Control_3	No exercise and supplements not containing food ingredients for 24 weeks
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	60 years-old <=
Age-upper limit	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Women and men aged 60 to 79 years. 2) Person who does not engage regular exercise. 3) Person who has self-identified forgetfulness. 4) Person who can come to the medical organization for the measurement at the date of visiting. 5) Person who can understand the purpose and content of this study and agree in writing to participate in this study.
Key exclusion criteria	1) Presence of dementia or suspicion of dementia. 2) Presence of previous and present serious disease such as neurological disorder, psychiatric disorder, liver disorder, kidney disorder, lung disorder, cardiovascular disorder, diabetes mellitus, food allergy. 3) Presence of health problems to reciving exercise interventions. 4) Use of product affecting the data of this study, such as medicine, food for specified health use, supplement, diet food. 5) Investigator's judgment for other reason.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshihisa Kaneda
Organization	Suntory Wellness Limited
Division name	Institute For Health Care Science
Zip code
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto. 619-0284, Japan
TEL	050-3182-0654
Email	Yoshihisa_Kaneda@suntory.co.jp

Public contact
Name of contact person	1st name Middle name Last name Hisanori Tokuda
Organization	Suntory Wellness Limited
Division name	Institute For Health Care Science
Zip code
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto. 619-0284, Japan
TEL	050-3182-0662
Homepage URL
Email	Hisanori_Tokuda@suntory.co.jp

Sponsor
Institute	Suntory Wellness Limited
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2019 Year 10 Month 23 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	2017 Year 11 Month 09 Day
Date of IRB	2017 Year 11 Month 09 Day
Anticipated trial start date	2017 Year 11 Month 27 Day
Last follow-up date	2018 Year 12 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 11 Month 21 Day
Last modified on	2019 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034331