obesity
Conditions
Interventions
Administered escalating doses start from 110mg/day to 440mg/day. Each dose of a Coleus forskohlii formulation is administered for one week
ie oral intake of 1st wk is 110mg/day, 2nd wk is 220mg/day, 3rd wk is 330mg/day, and 4th wk is 440mg/day. A formulation contains 110mg of CF extract and 100mg of coconut oil per capsule. Each dose inc
Sponsors
DHC Corporation
Suidobashi Medical Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age: more than or equal to 20 years at the time of providing informed consent - Healthy individuals who have never experienced psychological and critical diseases. - Healthy individuals who have the ability to provide written informed consent.
Exclusion criteria
Exclusion criteria: - Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc.) and who is taking any drugs. - Subjects judged to be inappropriate for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is safety evaluation as phase I. Adverse events are recorded daily basis until 1 week after the intervention. Physician's interview and the physical examinations at the basis and the completion of the intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective questionnaire (the preliminary observation period;1 week, the intervention period, and the post-intervention period;1 week.) | — |
Countries
Japan
Contacts
Public ContactSeika Kamohara
DHC Corporation Division of Research Adviser
Outcome results
None listed