Japanese adults with level 1 or higher obesity of the criteria by Japan Society for the Study of Obesity
Conditions
Interventions
To investigate changes in BMI, body weight, and vital signs at 2 and 4 weeks after taking the prescribed healthy meal (3 times a day + snack) for 28 days.
Sponsors
InCROM Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject who was given explanation about the objective, methods, study period, and expected detriment, etc. of this study, understood them, and gave informed consent on a voluntary basis. 2. The Japanese adult male or female aged 20 to 65 years, inclusive, at the time of informed consent 3. The subject whose BMI is 25.0 or over (level 1 or higher obesity level of the obesity criteria by Japan Society for the Study of Obesity) 4. The subject who can comply with the study rules and communicate subjective symptoms, etc.
Exclusion criteria
Exclusion criteria: 1. The subject who has hepatic, renal, cardiovascular, respiratory, endocrine system, metabolic, neurological, or psychiatric disorder, or who was assessed to have a past history of any of these diseases by the principal investigator or subinvestigators (excluding subjects with lifestyle related diseases including hypertension, dyslipidemia, or diabetes mellitus who were assessed eligible for this study by the principal investigator) 2. The subject who has drug or food allergy 3. The subject who has drug or alcohol dependence 4. In addition, the subject who was assessed ineligible for the study by the principal investigator or subinvestigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chages in BMI | — |
Secondary
| Measure | Time frame |
|---|---|
| Chages in body weights, vital signs, and clinical laboratory tests | — |
Countries
Japan
Contacts
Public ContactHiroshi Mikami
Medical Corporation Heishinkai OPHAC Hospital Hospital Director
Outcome results
None listed