UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041588 |
|---|---|
| Receipt number | R000047476 |
| Scientific Title | Search for nutritional supplements to enhance exercise training adherence |
| Date of disclosure of the study information | 2020/08/28 |
| Last modified on | 2020/08/28 13:20:55 |
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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
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
masuki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047476
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
