UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021909
Receipt number R000025271
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
Date of disclosure of the study information 2016/04/14
Last modified on 2020/05/02 15:11:57

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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 or person

Institute

Institute of Interdisciplinary Research,
Kyoto University of Advanced Science

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025271


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name