Healthy adults
Conditions
Interventions
Intake of soy isoflavones extract (control food, single ingestion) - washout period - intake of soy isoflavones extract (test food, single ingestion).
Intake of soy isoflavones extract (test food, sin
Sponsors
FANCL Corporation
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Japanese postmenopausal women from 45 to 59 years of age. 2) Subjects whose BMI are more than 18.5 kg/m2 less than 25.0 kg/m2. 3) Subjects who have been fully informed of the purpose and content of the study, fully understand it, agree to voluntarily participate in the study, and are able to sign the consent form.
Exclusion criteria
Exclusion criteria: 1) Subjects with a serious medical history or gastrointestinal surgery. 2) Subjects with diseases affecting digestion/absorption, or with daily symptoms of indigestion, constipation, diarrhea, etc. 3) Subjects have renal, hepatic, cardiac, or other metabolic diseases. 4) Subjects who are undergoing treatment that affects the study, have a disease that requires treatment, or are regular users of pharmaceuticals. 5) Subjects who regularly use drugs or foods that may affect the study. 6) Subjects unable to discontinue soy-containing foods intake from 3 days prior to the start of test foods intake until the end of each period. 7) Subjects unable to consume the test foods and the designated diets in the admission due to preferences, allergies, etc. 8) Subjects are heavy alcohol drinkers or smokers. 9) Subjects who have difficulty collecting blood samples over time. 10) Subjects who underwent a whole blood withdrawal of 200 mL or more within the 4 weeks prior to the start of test foods intake, or 400 mL or more within the 12 weeks prior to the start of the study. 11) Subjects who participated in another clinical trial within 4 weeks prior to the start of test foods intake, and who are currently or who has plans to participate in another clinical trial from the present or until the end of the study. 12) Subjects with irregular sleep or dietary habits due to night work or insomnia. 13) Subjects engaged in intense physical exercise. 14) Subjects who are judged to be unsuitable as subjects by the principal investigator or others.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC 0-24h for postprandial serum total isoflavones concentrations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum total isoflavones, daidzein, genistein and glycitein concentrations, AUC at each time point. Cmax and Tmax of Serum total isoflavones, daidzein, genistein and glycitein. | — |
Countries
Japan
Contacts
Public ContactNaoyuki Abe
Medical Corporation Jikokai Clinical Trial Division
Outcome results
None listed