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 |
Changes of body composition after replacing dietary carbohydrate with a protein supplement in overweight Japanese subjects
Changes of body composition after replacing dietary carbohydrate with a protein supplement in overweight Japanese subjects
Changes of body composition after replacing dietary carbohydrate with a protein supplement in overweight Japanese subjects
Changes of body composition after replacing dietary carbohydrate with a protein supplement in overweight Japanese subjects
Japan |
Obesity
Endocrinology and Metabolism |
Others
NO
Inspect the most suitable nutritional balance for overweight Japanese subjects
Safety,Efficacy
the change of muscle mass from baseline after each 48-week dietary intervention period
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Food |
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.
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.
20 | years-old | <= |
60 | years-old | >= |
Male and Female
BMI 25.0-40.0 kg/m2
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.
24
1st name | |
Middle name | |
Last name | Yasushi Tanaka |
St. Marianna university school of medicine
Division of metabolism and endocrinology, department of internal medicine.
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan.
+81-44-977-8111
y17tnk@marianna-u.ac.jp
1st name | |
Middle name | |
Last name | Yosuke Sasaki |
St. Marianna university school of medicine
Division of metabolism and endocrinology, department of internal medicine.
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan.
+81-44-977-8111
y2sasaki@marianna-u.ac.jp
St. Marianna university school of medicine
Japan science and technology agency
Japanese Governmental office
NO
2018 | Year | 08 | Month | 23 | Day |
Unpublished
Completed
2016 | Year | 04 | Month | 11 | Day |
2016 | Year | 09 | Month | 01 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 08 | Month | 23 | Day |
2018 | Year | 08 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038615