UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047548 |
|---|---|
| Receipt number | R000054215 |
| Scientific Title | Basic research on changes in nutritional status during exercise (3) (Effects of body weight loss on nutritional status and metabolism -Comparison of dietary restriction or combined dietary restriction and exercise-) |
| Date of disclosure of the study information | 2022/04/22 |
| Last modified on | 2022/08/28 14:50:24 |
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Basic information
Public title
Basic research on changes in nutritional status during exercise (3) (Effects of body weight loss by combined dietary restriction and exercise)
Acronym
Body weight loss by combined dietary restriction and exercise
Scientific Title
Basic research on changes in nutritional status during exercise (3) (Effects of body weight loss on nutritional status and metabolism -Comparison of dietary restriction or combined dietary restriction and exercise-)
Scientific Title:Acronym
Body weight loss by dietary restriction or combined dietary restriction and exercise
Region
| Japan |
Condition
Condition
Healthy person (Adult)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of exercise intervention on body weight loss programs
Basic objectives2
Others
Basic objectives -Others
To examine the differences between [dietary restriction] and [dietary restriction + exercise] regarding the effects of body weight loss on glucose and lipid metabolism and nutritional status
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose and lipid metabolism-related parameters (before and after body weight loss program)
Key secondary outcomes
Blood protein, mineral and vitamin metabolism-related parameters (before and after body weight loss program)
Urinary, fecal and sweat nutritional status-related parameters (before and during body weight loss program)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
[adjustment period] 5 days, [dietary restriction] 5 days, washout period, [adjustment period] 5 days, [dietary restriction + exercise] 5 days
(The magnitude of the induced negative energy balance is one-half of the energy intake during the body weight-maintained adjustment period.)
Interventions/Control_2
[adjustment period] 5 days, [dietary restriction + exercise] 5 days, washout period, [adjustment period] 5 days, [dietary restriction] 5 days
(The magnitude of the induced negative energy balance is one-half of the energy intake during the body weight-maintained adjustment period.)
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy men or women between the ages of 18 and 40
Key exclusion criteria
If abnormal findings are found in the medical examination
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Yamada |
Organization
Kanto Gakuin University
Division name
Department of Nutrition and Dietetics
Zip code
236-8503
Address
1-50-1 Mutsuura-higashi, Kanazawa-ku, Yokohama, Japan
TEL
045-786-7221
tyyamada@kanto-gakuin.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuo |
| Middle name | |
| Last name | Yamada |
Organization
Kanto Gakuin University
Division name
Department of Nutrition and Dietetics
Zip code
236-8503
Address
1-50-1 Mutsuura-higashi, Kanazawa-ku, Yokohama, Japan
TEL
045-786-7221
Homepage URL
tyyamada@kanto-gakuin.ac.jp
Sponsor or person
Institute
Kanto Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Kanto Gakuin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanto Gakuin University
Address
1-50-1 Mutsuura-higashi, Kanazawa-ku, Yokohama, Japan
Tel
045-786-2924
kenkyu@kanto-gakuin.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
| 2022 | Year | 04 | Month | 22 | 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
6
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to the delay in publication in academic journals
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
| 2006 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2006 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2006 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 09 | 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
| 2022 | Year | 04 | Month | 21 | Day |
Last modified on
| 2022 | 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=R000054215
