UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032881 |
|---|---|
| Receipt number | R000037337 |
| Scientific Title | Effect of weight reduction on cognitive function in overweight adults |
| Date of disclosure of the study information | 2018/06/06 |
| Last modified on | 2022/06/08 16:22:07 |
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Basic information
Public title
Effect of weight reduction on cognitive function in overweight adults
Acronym
Effect of weight reduction on cognitive function in overwiehght adults
Scientific Title
Effect of weight reduction on cognitive function in overweight adults
Scientific Title:Acronym
Effect of weight reduction on cognitive function in overwiehght adults
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to evaluate the effects of weight reduction by low-carbohydrate diet and exercise on brain structure and cognitive function in overweight adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in cognitive function between baseline and 6 months after the start of diet program
Key secondary outcomes
Change in brain structure, body consumption and blood component between baseline and 6 months after the start of diet program
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
| Other |
Interventions/Control_1
Diet program by combination of low-carbohydrate diet and resistance excercise (50 minutes; 2 days/week) for a couple of months
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
People whose BMI is 25kg/m2 and more at the time of entry
Key exclusion criteria
People who suffer from any serious physical disorders
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kunugi |
| Middle name | |
| Last name | Hiroshi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Mental Disorder Research, National Institute of Neuroscience
Zip code
187-8502
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL
042-346-1714
hkunugi@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Matsuo |
| Middle name | |
| Last name | Junko |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Mental Disorder Research, National Institute of Neuroscience
Zip code
187-8502
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL
042-341-2712(ext.5135)
Homepage URL
https://www.ncnp.go.jp/nin/guide/r3/
matsujun@ncnp.go.jp
Sponsor or person
Institute
Department of Mental Disorder Research, National Institute of Neuroscience, National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
An Intramural Research Grants (30-3) for Neurological and Psychiatric Disorders of National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
RIZAP Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Mental Disorder Research, National Institute of Neuroscience, National Center of Neurology and Psychiatry
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo, Japan
Tel
042-341-2712(ext.5135)
matsujun@ncnp.go.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
国立精神・神経医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 06 | 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
0
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
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2022 | 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
| 2018 | Year | 06 | Month | 05 | Day |
Last modified on
| 2022 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037337
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
