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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021749
Receipt No. R000025081
Scientific Title 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
Date of disclosure of the study information 2016/04/14
Last modified on 2019/03/08

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Basic information
Public title 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
Acronym The effect of probiotics and resistance exercise on cognitive function, physical performance, and intestinal flora in the elderly
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Narumi Nagai
Organization University of Hyogo
Division name School of Human Science and Environment
Zip code
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
1st name
Middle name
Last name Narumi Nagai
Organization University of Hyogo
Division name School of Human Science and Environment
Zip code
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)

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 14 Day

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

Result
URL related to results and publications https://www.wageningenacademic.com/doi/pdf/10.3920/BM2017.0193
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 01 Day
Date of IRB
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

Other
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

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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