UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037408 |
|---|---|
| Receipt number | R000042653 |
| Scientific Title | Effect of combination of diet restriction and exercise on physical functions and cardiovascular diseases risk factors in middle-aged females |
| Date of disclosure of the study information | 2019/07/18 |
| Last modified on | 2025/01/20 09:47:56 |
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Basic information
Public title
Effect of combination of diet restriction and exercise on physical functions in middle-aged females
Acronym
Effects of diet restriction and exercise on physical functions
Scientific Title
Effect of combination of diet restriction and exercise on physical functions and cardiovascular diseases risk factors in middle-aged females
Scientific Title:Acronym
Effect of combination of diet restriction and exercise on physical functions and cardiovascular diseases risk factors
Region
| Japan |
Condition
Condition
A healthy population
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effect of combination of diet restriction and exercise on physical functions and cardiovascular diseases risk factors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatty acid binding protein 4
Key secondary outcomes
Leg muscle strength
Sit and reach
1 mile walking time
Blood pressure
High-density lipoprotein cholesterol
Low-density lipoprotein cholesterol
Triglyceride
Fasting blood glucose
Insulin
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Diet restriction and exercise group
Interventions/Control_2
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
| 45 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Not restricted by a medical doctor from exercise and diet restriction
2. A body mass index is less than 35
3 Not participate in another clinical trial in one year
4. Can agree with contents of study
Key exclusion criteria
1. Have severe heart disease, cerebrovascular disease, and renal dysfunction
2. Medical doctor cannot agree with participation in study
3. Current or planned pregnancy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Nakagaichi |
Organization
National Institute of Fitness and Sports in Kanoya
Division name
Faculty of Sports and Life Science
Zip code
891-2393
Address
1 Shirommizu, Kanoya, Kagoshima, 891-2393, Japan
TEL
+81-994-46-4947
gaichi@nifs-k.ac.jp
Public contact
Name of contact person
| 1st name | Shigeharu |
| Middle name | |
| Last name | Numao |
Organization
National Institute of Fitness and Sports in Kanoya
Division name
Faculty of Sports and Life Science
Zip code
891-2393
Address
1 Shirommizu, Kanoya, Kagoshima, 891-2393, Japan
TEL
+81-994-46-4946
Homepage URL
numashige@nifs-k.ac.jp
Sponsor or person
Institute
National Institute of Fitness and Sports in Kanoya
Institute
Department
Personal name
Funding Source
Organization
Kijo, Miyazaki, Japan
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute of Fitness and Sports in Kanoya
Address
1 Shirommizu, Kanoya, Kagoshima, 891-2393, Japan
Tel
+81-994-46-4878
kokusai@nifs-k.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
| 2019 | Year | 07 | Month | 18 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 24 | 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
| 2019 | Year | 07 | Month | 18 | Day |
Last modified on
| 2025 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042653
