Healthy male/female volunteers
Conditions
Interventions
Intake of tablets containing diosgenin
Intake of soft capsules containing diosgenin
Sponsors
NihonbashiSakura Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese male and female aged 40 years and older at the time of informed consent 2) Females must be menopausal 3) Subjects who have been fully informed of the purpose and content of the study and who have signed a consent form prior to the start of the study
Exclusion criteria
Exclusion criteria: 1)Non-menopausal women 2)Subjects on medication due to a history or current history of intestinal disease (irritable bowel syndrome, Crohn's disease), liver disease, renal disease, cardiovascular disease (brain and heart), diabetes, dyslipidemia, hypertension, epileptic seizures, sleep apnea syndrome, or other chronic diseases 3)Subjects with a history of gastrointestinal tract surgery (except for appendectomy) 4)Subjects who are regularly using health foods (food for specified health use, nutritional supplements, functional foods, supplements, etc.) that may affect the test items 5)Subjects who are unable to discontinue the intake of pharmaceuticals (excluding intravenous administration), quasi-drugs, or health foods (food for specified health uses, nutritional supplements, foods with functional claims, supplements, etc.) from the time of obtaining consent to the completion of the study 6)Heavy alcohol drinkers (average net alcohol consumption: 60 g/day or more) 7)Subjects who have an extremely irregular eating habits 8)Shift or night shift workers 9)Regular users of any kind of medication (including intestinal medicines, herbal medicines, and OTC drugs) 10)Subjects who plan to take any medication during the period of consumption of the test food (including painkillers such as headache medication) 11)Subjects who are allergic to yams 12)Subjects with perennial atopic dermatitis or allergy (e.g. rhinitis) 13)Subjects with a history of anaphylactic shock in the past 14)Subjects who are deemed inappropriate by the investigators and sub investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events and side effects, including abnormal changes in laboratory values. | — |
Secondary
| Measure | Time frame |
|---|---|
| Body measurements: weight, BMI and blood pressure | — |
Countries
Japan
Contacts
Public ContactYoshihiro Otake
feileB Co., Ltd Clinical Research Support dev.
Outcome results
None listed