UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033865 |
|---|---|
| Receipt number | 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 11:51:18 |
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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
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
y2sasaki@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna university school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038615
