Study on the absorption of isoflavones after ingestion of soy-containing supplements composed of different ingredients. -A randomized, open-label, 2-way, 2-period, cross-over study-

UMIN ID: UMIN000054337

Registered date:09/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2024/05/09
• Target sample size: 16
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intake of soy-containing supplements (test food-1, single ingestion) - washout period - intake of soy-containing supplements (test food-2, single ingestion).
Intake of soy-containing supplements (test food-2, single ingestion) - washout period - intake of soy-containing supplements (test food-1, single ingestion).

Outcome(s)

• Primary Outcome: AUC 0-24h for postprandial serum total isoflavones concentrations.
• Secondary Outcome: Serum total isoflavones, daidzein, genistein and glycitein concentrations, AUC at each time point. Cmax and Tmax of Serum total isoflavones, daidzein, genistein and glycitein. Total urinary excretion of equol 0-24h. Subgroup analysis of outcomes based on the equol-producing ability, menstruation, dietary habit and AUC for each intervention.

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 60years-old
• Gender: Female
• Exclude 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 who are pregnant, lactating, or may become so until the end of the study. 13) Subjects whose menstrual overlap with each period of the study. 14) Subjects with irregular sleep or dietary habits due to night work or insomnia. 15) Subjects engaged in intense physical exercise. 16) Subjects who are judged to be unsuitable as subjects by the principal investigator or others.

Related Information

• Primary Sponsor: FANCL Corporation
• Source(s) of Monetary Support: FANCL Corporation