UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021749 |
|---|---|
| Receipt number | 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 16:58:11 |
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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
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
nagai@shse.u-hyogo.ac.jp
Sponsor or person
Institute
University of Hyogo
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025081
