UMIN-CTR Clinical Trial

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
Email	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/
Email	matsujun@ncnp.go.jp

Sponsor
Institute	Department of Mental Disorder Research, National Institute of Neuroscience, National Center of Neurology and Psychiatry
Institute
Department

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)
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037337