UMIN-CTR Clinical Trial

Basic information
Public title	The effect of low intensity exercise intervention with and without capsaicin analogues on physical activity, fitness, body composition and psychological factors in community dwelling older adults
Acronym	The effect of low intensity exercise intervention with and without capsaicin analogues in community dwelling older adults
Scientific Title	The effect of low intensity exercise intervention with and without capsaicin analogues on physical activity, fitness, body composition and psychological factors in community dwelling older adults
Scientific Title:Acronym	The effect of low intensity exercise intervention with and without capsaicin analogues in community dwelling older adults
Region	Japan

Condition
Condition	Healthy community dwelling older adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the effect of low intensity exercise intervention with and without capsaicin analogues on physical activity, fitness, body composition and psychological factors in community dwelling older adults
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	> behavior factors: physical activity monitoring by triaxial accelerometer on the hip > psychological factors: Health Related Quality of Life (SF-36) and depression (GDS)
Key secondary outcomes	> physical fitness: one-leg standing, grip strength, leg muscle power, stepping test, sit-to-stand test, timed-up-and-go test, functional reach, leg muscle strength, gait speed, locomo-25, daily activity questionnaires, exercise habits > body composition: BMI, bioelectrical impedance analysis > cognitive function: SC-test etc. > sleeping quality and quantity: Pittsburgh Sleep Quality Index > physical activity indices: exercise log, IPAQ-E

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food Behavior,custom
Interventions/Control_1	The participants will take three capsule composed of 1.5mg of non-pungent capsaicin analogues (capsinoids) with 200mg of canola oil in the morning and evening. The exercise program is described elsewhere (http://www.kyoto-houkatucare.org/kaigo-yobou-manual/). The participants will conduct the exercise program in one 90 min session class per week. The participants will log their daily step count and exercise duration for the intervention period. The intervention duration is 12 weeks.
Interventions/Control_2	The participants will take three capsule composed of only 200mg of canola oil in the morning and evening. The exercise program is described elsewhere (http://www.kyoto-houkatucare.org/kaigo-yobou-manual/). The participants will conduct the exercise program in one 90 min session class per week. The participants will log their daily step count and exercise duration for the intervention period. The intervention duration is 12 weeks.
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	The subjects who participate the exercise program habitually and preserve the protocol.
Key exclusion criteria	The subjects who has allergy to capsicum The subjects who has a habit taking supplemental foods which may affect energy expenditure. The subjects who has lower BMI than 18.5 kg m-2 The subjects who are evaluated as inadequate subjects by principal or co-principal investigators, or responsible medical doctor.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Misaka Middle name Last name Kimura
Organization	Kyoto University of Advanced Science
Division name	Institute of Interdisciplinary Research,
Zip code	621-8555
Address	1-1 Nanjo-Otani, Sogabe, Kameoka, Kyoto, Japan
TEL	0771-56-8930
Email	kimura.misaka@kuas.ac.jp

Public contact
Name of contact person	1st name Misaka Middle name Last name Kimura
Organization	Kyoto University of Advanced Science
Division name	Institute of Interdisciplinary Research,
Zip code	621-8555
Address	1-1 Nanjo-Otani, Sogabe, Kameoka, Kyoto, Japan
TEL	0771-29-2354
Homepage URL
Email	kimura.misaka@kuas.ac.jp

Sponsor
Institute	Institute of Interdisciplinary Research, Kyoto University of Advanced Science
Institute
Department

Funding Source
Organization	AJINOMOTO CO.,INC
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto University of Advanced Science
Address	18 Gotanda-cho, Yamanouchi, Ukyo-ku, Kyoto, Japan
Tel	075-406-9210
Email	shibata.masamitsu@kuas.ac.jp

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
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	2016 Year 02 Month 01 Day
Date of IRB	2016 Year 03 Month 15 Day
Anticipated trial start date	2016 Year 04 Month 14 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 04 Month 14 Day
Last modified on	2020 Year 05 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025271