UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of probiotics and resistance exercise on cognitive function, physical performance, and intestinal flora in the elderly: a randomized, double-blind, placebo-controlled trial
Title of the study (Brief title)	The effect of probiotics and resistance exercise on cognitive function, physical performance, and intestinal flora in the elderly
Region	Japan

Condition
Condition	Elderly adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To investigate the effect of resistance training with/without probiotics on cognitive performance, mobility functions, and intestinal flora in the elderly.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognitive function - pre and post 12 week-intervention - single measurement, respectively
Key secondary outcomes	Physical performance, Frailty scale, Intestinal flora, Bowel movements, Psychological parameters, Blood examination, Inflammatory markers, Body composition measured electrical impedance equipment - pre and post 12 week-intervention - single measurement, respectively

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	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food Behavior,custom
Interventions/Control_1	Probiotic supplementation and resistance exercise for 12 weeks. - Supplementation: 2 gram-powder per day - Exercise: participation of 90 min-exercise class and additional exercise at home
Interventions/Control_2	Placebo and resistance exercise for 12 weeks. - Placebo: 2 gram-powder per day - Exercise: participation of 90 min-exercise class and additional exercise at home
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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Japanese 2) Age >=60 years 3) Not receiving care authorization in the Long-Term Care Insurance Law 4) Stretching and exercise over 1 year 5) Informed consent provided 6)Able to receive and take experimental supplements 7) Able to follow the instructions of the study team
Key exclusion criteria	1) Disease that exercise is prohibited from doctor (cardiovascular disease or other) 2) The diagnosis of dementia by a physician/taking medicine for dementia 3) Food allergy against materials in experimental supplements 4) Subjects judged by the investigator/project leader to be ineligible for other reasons
Target sample size	40

Research contact person
Name of lead principal investigator	Narumi Nagai
Organization	University of Hyogo
Division name	School of Human Science and Environment
Address	1-1-12 Shinzaike-honcho, Himeji, Hyogo, 670-0092 Japan
TEL	+81-79-292-1515
Email	nagai@shse.u-hyogo.ac.jp

Public contact
Name of contact person	Narumi Nagai
Organization	University of Hyogo
Division name	School of Human Science and Environment
Address	1-1-12 Shinzaike-honcho, Himeji, Hyogo, 670-0092 Japan
TEL	+81-79-292-1515
Homepage URL
Email	nagai@shse.u-hyogo.ac.jp

Sponsor
Institute	University of Hyogo
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	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Clinical Research Institute, National Hospital Organization Kyoto Medical Center
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 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 14 Day
Last follow-up date
Date of closure to data entry	2017 Year 01 Month 31 Day
Date trial data considered complete	2017 Year 02 Month 28 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol	https://www.wageningenacademic.com/doi/pdf/10.3920/BM2017.0193
Publication of results	Published
URL releasing results	https://www.wageningenacademic.com/doi/pdf/10.3920/BM2017.0193
Results
Other related information

Management information
Registered date	2016 Year 04 Month 01 Day
Last modified on	2019 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025081