UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes of body composition after replacing dietary carbohydrate with a protein supplement in overweight Japanese subjects
Title of the study (Brief title)	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	Yasushi Tanaka
Organization	St. Marianna university school of medicine
Division name	Division of metabolism and endocrinology, department of internal medicine.
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	Yosuke Sasaki
Organization	St. Marianna university school of medicine
Division name	Division of metabolism and endocrinology, department of internal medicine.
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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