UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027158 |
|---|---|
| Receipt number | R000031095 |
| Scientific Title | The effects of Amazake, a sweet rice wine lees drink, combined with resistance exercise on cognitive and mobility functions in the elderly: a randomized, double-blind, placebo-controlled trial |
| Date of disclosure of the study information | 2017/04/30 |
| Last modified on | 2018/04/28 15:22:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effects of Amazake, a sweet rice wine lees drink, combined with resistance exercise on cognitive and mobility functions in the elderly: a randomized, double-blind, placebo-controlled trial
Acronym
The effects of Amazake on Mobility, prevention of AlZheimer's disease And Knee pain in the Elderly: The AMAZAKE Study
Scientific Title
The effects of Amazake, a sweet rice wine lees drink, combined with resistance exercise on cognitive and mobility functions in the elderly: a randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym
The effects of Amazake on Mobility, prevention of AlZheimer's disease And Knee pain in the Elderly: The AMAZAKE Study
Region
| Japan |
Condition
Condition
the elderly
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the effects of effect of Amazake, a sweet rice wine lees drink, combined with resistance exercise on cognitive and mobility functions in the elderly
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in cognitive function at 12 weeks
Key secondary outcomes
Mobility function, Physical performance, Body composition measured using electrical impedance equipment, Knee-pain score, Inflammatory markers, Frailty scale, Psychological parameters, Blood examination, Bowel movement
- 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
YES
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
Amazake (a sweet rice wine lees drink) and guided resistance exercise for 12 weeks.
- Amazake supplementation: approximately 50 g/day, non-alcohol, freeze-dried powder made from rice wine lees.
- Exercise: participation of guided resistance exercise class (90 min/w) and additional home exercise
Interventions/Control_2
Placebo drink and guided resistance exercise for 12 weeks.
- Placebo: approximately 50 g/day
-Exercise: participation of guided resistance exercise class (90 min/w) and additional home exercise
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. The elderly (ages <= 65 years)
3. Doing exercise for more than 1 year, such as stretching
4. Having provided voluntary written consent for participation in this study
5.Able to receive and take experimental supplements
6. Able to follow the instructions of the research team member
Key exclusion criteria
1. Prohibited from doing exercise by a doctor (cardiovascular disease or other)
2. Already diagnosed as dementia by a physician or prescribed drugs for treating dementia
3. Already received nursing care certification in the Long-Term Care Insurance Law
4. Having food allergy to materials or ingredients of experimental supplement
5. Judged by the investigator/project leader to be ineligible for other reason
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
School of Human Science and Environment, 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
Japan
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
| 2017 | Year | 04 | Month | 30 | 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 | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
| 2017 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 25 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 27 | Day |
Last modified on
| 2018 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031095
