UMIN-CTR Clinical Trial

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
Email	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
Email	tyyamada@kanto-gakuin.ac.jp

Sponsor
Institute	Kanto Gakuin University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054215