UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	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	School of Human Science and Environment, 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	Japan

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	2017 Year 04 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031095