Healthy Adult
Conditions
Interventions
Acacia Honey Intake amount: 15 g/day Intake duration: 84 days
Sponsors
Yamada Bee Company, Inc.
Research Center for Immunological Analysis, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy Japanese subjects between the ages of 20 and 65 at the time of informed consent. 2) Subjects not receiving treatment with medications, therapies, or procedures for any reason, whether seasonal, chronic, or acute. 3) Subjects who have fully understood this clinical study and have provided written informed consent of their own free will. 4) Subjects with a BMI greater than 18.5 and less than 30.0. *BMI = Weight (kg) / {Height (m)}^2* 5) Subjects who can refrain from excessive exercise during the clinical study period. 6) Subjects who can maintain a diet of three meals per day and avoid overeating and excessive drinking during the clinical study period. 7) Subjects who can understand and comply with the management instructions during the clinical study period. 8) Subjects deemed eligible by the principal investigator or equivalent based on a comprehensive assessment.
Exclusion criteria
Exclusion criteria: 1) Subjects with diseases of the gastrointestinal tract, liver, kidneys, heart, or circulatory system that affect the absorption, distribution, metabolism, or excretion of the test food. 2) Subjects with a history of major surgery of the gastrointestinal tract, such as gastrectomy, gastrointestinal suture, or bowel resection (except polypectomy and appendectomy). 3) Subjects with a history of cerebrovascular disease (except asymptomatic lacunar infarction). 4) Subjects with food allergies or hypersensitivity related to the test food, or with specific constitutions. 5) Subjects suspected of alcohol or drug abuse. 6) Subjects who have participated in another clinical trial or study within 84 days prior to the date of consent. 7) Subjects who have donated 400 mL of blood within 84 days, 200 mL of blood within 28 days, or received a component blood donation (plasma or platelets) within 14 days prior to the date of consent. 8) Subjects unable to refrain from consuming honey other than the test food during the study period. 9) Subjects with a postprandial glucose level of 140 mg/dL or higher at the time of SCR, or who have been diagnosed with diabetes by a physician at the time of application. 10) Subjects who wish to become pregnant or who are unable to use contraception during the clinical trial period. 11) Subjects who are breastfeeding or pregnant. 12) Subjects with irregular lifestyles due to night shifts or shift work. 13) Subjects who live with someone who is participating or planning to participate in the study. 14) Any other subjects deemed inappropriate for participation by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (medical interview) General tests (BMI, blood pressure, pulse rate) Hematological tests Blood biochemical tests Urinalysis Diary | — |
Countries
Japan
Contacts
Public ContactAkio Ohkuma
Research Center for Immunological Analysis, Inc. -
Outcome results
None listed