Obesity classification 1 and 2 as defined by the Japan Society for the Study of Obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes over time in body weight, BMI, vital signs and clinical laboratory tests | — |
Countries
Japan
Contacts
Heishinkai Medical Group Incorporated, OCROM Clinic Director