UMIN-CTR Clinical Trial

Basic information
Public title	Search for nutritional supplements to facilitate habitual exercise training
Acronym	Habitual exercise and nutritional supplements
Scientific Title	Search for nutritional supplements to enhance exercise training adherence
Scientific Title:Acronym	Supplement intake and exercise training adherence
Region	Japan

Condition
Condition	Life-style related diseases
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of yoghurt intake immediately after daily exercise on exercise training adherence
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Exercise training days during the intervention, exercise training time per day.
Key secondary outcomes	Herat rate response to a given exercise intensity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Interval walking training + yoghurt intake
Interventions/Control_2	Interval walking trainig + placebo intake
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	40 years-old <=
Age-upper limit	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Those who has participated in the health promotion program for elderly, "Matsumoto Jukunen Taiikudaigaku" project more than 6 months. 2)Those who can walk independently. 3) Those who do not show allergic responses to milk products 4) Those who give us an informed consetnt to participate in the study after face-to-face explanation by investigators.
Key exclusion criteria	1) Those who do not clear the criteria stated above. 2) Those who are inadequate persons as subjects, a primary investigator judges.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Shizue Middle name Last name Masuki
Organization	Shinshu University
Division name	Grdauate School of Medicine
Zip code	390-8621
Address	3-1-1 Asahi, Matsumoto, Nagano Prefecture
TEL	0263-37-2682
Email	masuki@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Shizue Middle name Last name Masuki
Organization	Shinshu University
Division name	Graduate School of Medicine
Zip code	390-8621
Address	3-1-1 Asahi, Matumoto, Nagano Prefecture
TEL	0263-37-2682
Homepage URL
Email	masuki@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

Funding Source
Organization	MECSST
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shinshu University
Address	3-1-1 Asahi, Matumoto, Nagano Prefecture
Tel	0263-37-2572
Email	mdrinri@shinshu-u.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	2020 Year 08 Month 28 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	Enrolling by invitation
Date of protocol fixation	2020 Year 08 Month 10 Day
Date of IRB	2020 Year 08 Month 10 Day
Anticipated trial start date	2020 Year 08 Month 10 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 28 Day
Last modified on	2020 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047476