Unique ID issued by UMIN | UMIN000028927 |
---|---|
Receipt number | R000033051 |
Scientific Title | Effects of health food products on weight loss in Japanese volunteers whose obesity classification is 1 or 2 as defined by the Japan Society for the Study of Obesity |
Date of disclosure of the study information | 2017/09/05 |
Last modified on | 2018/04/05 15:14:43 |
Effects of health food products on weight loss in Japanese volunteers whose obesity classification is 1 or 2 as defined by the Japan Society for the Study of Obesity
Effects of health food products on weight loss in Japanese obese volunteers
Effects of health food products on weight loss in Japanese volunteers whose obesity classification is 1 or 2 as defined by the Japan Society for the Study of Obesity
Effects of health food products on weight loss in Japanese obese volunteers
Japan |
Obesity classification 1 and 2 as defined by the Japan Society for the Study of Obesity
Not applicable |
Others
NO
To investigate the effects of test diets on body weight and BMI when ingested once to 6 times daily for 4 or 8 weeks and on changes in body weight and BMI 8 weeks after end of test diets in male and female volunteers whose obesity classification is 1 or 2. Changes in study variables over time will be investigated within each test diet and no inter-group comparisons will be made.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Changes in body weight and BMI from baseline (before start of test diets) to end of test diets and 8 week thereafter, and changes in body weight and BMI from end of test diets to 8 weeks thereafter
Changes over time in body weight, BMI, vital signs and clinical laboratory tests
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Food |
Subjects will consume one of the 4 test diets. Test diet A (low-carbohydrate, energy-restricted meal or snack; approx. 1400 kcal/day with approx. 25% of "available carbohydrates" [saccharides]) will be ingested 6 times/day for 8 weeks. Test diet B (moderately low-carbohydrate meal or snack; approx. 1400 kcal/day with approx. 40% of available carbohydrates) will be ingested 4 times/day for 8 weeks. Test diet C (low-carbohydrate, energy-restricted meal; approx. 250 kcal/meal with approx. 30% of available carbohydrates) will substitute one of 3 meals daily for 4 weeks. Test diet D (hummus 120 g; approx. 260-400 kcal/120 g with approx. 15% of available carbohydrates in average) will be ingested daily together with regular meals for 4 weeks.
20 | years-old | <= |
65 | years-old | >= |
Male and Female
Japanese adults who voluntarily give written informed consent; who wish to lose weight by ingesting health food products; whose BMI is >= 25.0 and < 35.0 when giving informed consent, i.e., obesity classification 1 or 2 as defined by the Japan Society for the Study of Obesity; and who are capable of recording body weight and other health-related data using the specified smartphone application
Diabetic patients
History of previous or present illness that interferes with ethical conduct of the research as determined by the investigator, e.g., hepatic or renal disorder; cardiovascular, respiratory, endocrine, metabolic, nervous, or psychological disease (except hypertension and dyslipidemia)
Known drug or food allergy
History of previous or present drug or alcohol dependence
90
1st name | |
Middle name | |
Last name | Hisayoshi Daito |
Heishinkai Medical Group Incorporated, OCROM Clinic
Director
4-12-11, Kasuga, Suita-shi, Osaka 565-0853, Japan
06-6330-8810
hisayoshi.daito@heishinkai.com
1st name | |
Middle name | |
Last name | Hisayoshi Daito |
Heishinkai Medical Group Incorporated, OCROM Clinic
Director
4-12-11, Kasuga, Suita-shi, Osaka 565-0853, Japan
06-6330-8810
hisayoshi.daito@heishinkai.com
InCROM Inc.
Partnership Support Project for Enhancement of Commercial and Service Competitiveness 2017 (New Partnership Support Program)
Japanese Governmental office
Japan
InCROM Inc.
InCROM Plus Inc.
NO
医療法人 平心会 OCROMクリニック(大阪府)/Heishinkai Medical Group Incorporated, OCROM Clinic (Osaka, Japan)
2017 | Year | 09 | Month | 05 | Day |
Unpublished
A total of 93 subjects started the study diet. Of these 76 completed the study. 78 subjects who had evaluable efficacy data were included in the efficacy analysis set, comprising 13 subjects (M: 5, F: 8) for test diet A, 11 (M: 8, F: 3) for B, 27 (M: 13, F: 14) for C, and 27 subjects (M: 20, F: 7) for test diet D.
Percent changes in body weight from baseline to end of test diet and 8 weeks thereafter, and those from end of test diet to 8 weeks thereafter were as follows: -5.8%, -3.8%, 1.7% for diet A, -6.2%, -6.2%, 0.0% for B, -1.5%, -2.5%, -1.0% for C, and -0.0%, -0.5%, -0.4% for diet D. Body weight in diet A was significantly reduced from baseline to end of diet and 8 weeks thereafter, however, it was significantly increased from end of diet to 8 weeks thereafter. Body weight decreases in diets B and C were significant from baseline to end of diet and 8 weeks thereafter, whereas no differences were noted between end of diet and 8 weeks thereafter. Subjects consuming diet D did not show changes in body weight. Changes in BMI were comparable to those in body weight for all diet groups.
Decreases in blood pressure, triglycerides, total cholesterol, LDL cholesterol and gamma-GTP were observed for diets A and B. Three (3.2%) out of 93 subjects experienced a total of 3 adverse events related to test diet, all of which were mild in intensity and none of them were clinically significant.
Completed
2017 | Year | 08 | Month | 09 | Day |
2017 | Year | 09 | Month | 13 | Day |
2018 | Year | 02 | Month | 04 | Day |
2018 | Year | 02 | Month | 08 | Day |
2018 | Year | 02 | Month | 20 | Day |
2018 | Year | 03 | Month | 28 | Day |
2017 | Year | 08 | Month | 31 | Day |
2018 | Year | 04 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033051
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |