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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033865
Receipt No. R000038615
Scientific Title Changes of body composition after replacing dietary carbohydrate with a protein supplement in overweight Japanese subjects
Date of disclosure of the study information 2018/08/23
Last modified on 2018/08/23

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Basic information
Public title Changes of body composition after replacing dietary carbohydrate with a protein supplement in overweight Japanese subjects
Acronym Changes of body composition after replacing dietary carbohydrate with a protein supplement in overweight Japanese subjects
Scientific Title Changes of body composition after replacing dietary carbohydrate with a protein supplement in overweight Japanese subjects
Scientific Title:Acronym Changes of body composition after replacing dietary carbohydrate with a protein supplement in overweight Japanese subjects
Region
Japan

Condition
Condition Obesity
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Inspect the most suitable nutritional balance for overweight Japanese subjects
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the change of muscle mass from baseline after each 48-week dietary intervention period
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Trained nutritionists interviewed each subject to calculate ideal body weight (IBW) and assess their daily diet. Then the subjects were instructed to reduce their dietary intake to between 25-27kcal/kg IBW/day based on their usual meal pattern. Participant-nutritionist contact in person was provided throughout the study period (48 weeks) once every 8 weeks.
Interventions/Control_2 Participants allocated to the protein replaced group were instructed to restrict dietary carbohydrate by 200 kcal/day and replace the same energy with a soy protein supplement (SAVAS WEIGHT DOWN: Meiji Co., Ltd., Tokyo, Japan) dissolved in water.
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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria BMI 25.0-40.0 kg/m2
Key exclusion criteria The exclusion criteria were as follows: 1) current treatment for life style related disease, such as diabetes, hypertension, and dyslipidemia, 2) a history of coronary artery disease, coronary revascularization, stroke, or transient ischemic attacks 3) malignancy, 4) renal dysfunction (estimated glomerular filtration rate < 60 mL/min/1.73 m2), 5) women who were pregnant, possibly pregnant, planned to become pregnant, or were breast-feeding, and 6) other patients who were considered to be ineligible for the study by the attending doctor.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Tanaka
Organization St. Marianna university school of medicine
Division name Division of metabolism and endocrinology, department of internal medicine.
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan.
TEL +81-44-977-8111
Email y17tnk@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Sasaki
Organization St. Marianna university school of medicine
Division name Division of metabolism and endocrinology, department of internal medicine.
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan.
TEL +81-44-977-8111
Homepage URL
Email y2sasaki@marianna-u.ac.jp

Sponsor
Institute St. Marianna university school of medicine
Institute
Department

Funding Source
Organization Japan science and technology agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 08 Month 23 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
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 Completed
Date of protocol fixation
2016 Year 04 Month 11 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2018 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 08 Month 23 Day
Last modified on
2018 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038615

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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