UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048507 |
|---|---|
| Receipt number | R000055279 |
| Scientific Title | The effects of dietary and exercise interventions on physical function in older adults |
| Date of disclosure of the study information | 2022/08/09 |
| Last modified on | 2023/10/31 14:39:12 |
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Basic information
Public title
The effects of diet and physical activity on physical function in older adults
Acronym
The effects of diet and physical activity on physical function
Scientific Title
The effects of dietary and exercise interventions on physical function in older adults
Scientific Title:Acronym
The effects of dietary and exercise interventions on physical function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of milk constituent supplementation and physical activity on physical function in older women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical function tests
Key secondary outcomes
Questionnaires on quality of life and daily life
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
4
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Participants consume a milk constituent supplement per day for 12 weeks. The outcomes are measured at baseline, 4 weeks, 8 weeks and 12 weeks.
Interventions/Control_2
Participants consume a placebo supplement per day for 12 weeks. The outcomes are measured at baseline, 4 weeks, 8 weeks and 12 weeks.
Interventions/Control_3
Participants consume a milk constituent supplement per day and increase their daily activity for 12 weeks. The outcomes are measured at baseline, 4 weeks, 8 weeks and 12 weeks.
Interventions/Control_4
Participants consume a placebo supplement per day and increase their daily activity for 12 weeks. The outcomes are measured at baseline, 4 weeks, 8 weeks and 12 weeks.
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
| 79 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Participants who are aged 60-79 years old.
2.Participants who are able to spend activity their daily life although they have lower physical function.
3.Participants who have no medical and surgical disorders.
4.Participants who are non-smokers.
5.Participants who have not gained or reduced weight in the past 3 months or who will not intend to lose weight within the examination period.
6.Participants who have no milk allergies
7.Participants who have no protein restriction.
8.Participants who are not dementia.
9.Participants who have no requirement for a certification of needed long-term care.
10.Participants who have no back and knee pains.
Key exclusion criteria
1. Participants who are aged below 59 years old or above 80 years old.
2. Participants who have no issue on physical function or who are not extremely lower daily activity levels.
3. Participants who have medical and surgical disorders.
4. Participants who are smokers.
5. Participants who have gained or reduced weight in the past 3 months or who will intend to lose weight within the examination period.
6. Participants who have milk allergies.
7. Participants who have protein restriction.
8. Participants who are dementia.
9. Participants who have a requirement for a certification of needed long-term care.
10. Participants who have back and knee pains.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Miyashita |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6774
m.miyashita@waseda.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Miyashita |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6774
Homepage URL
m.miyashita@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Waseda University
Address
1-104 Totsuka-cho, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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
| 2022 | Year | 08 | Month | 09 | 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
| 2021 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 07 | Month | 29 | Day |
Last modified on
| 2023 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055279
