Tokyo, Jan. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060512) titled 'Safety Study of Long-term Intake of Honeydew Honey in Healthy Participants' on Jan. 30.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Yamada Bee Company, Inc.
Condition:
Condition - Healthy Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the safety of long-term intake of honeydew honey (15 g/day for 12 weeks) in healthy adult men and women.
Additionally, metabolome analysis will be conducted to exploratorily investigate the functionality of honeydew honey.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Honeydew Honey
Intake amount: 15 g/day
Intake duration: 84 days
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Healthy Japanese participants between the ages of 20 and 65 at the time of informed consent.
2) Participants not receiving treatment with medications, therapies, or procedures for any reason, whether seasonal, chronic, or acute.
3) Participants who have fully understood this clinical study and have provided written informed consent of their own free will.
4) Participants with a BMI greater than 18.5 and less than 30.0.
*BMI = Weight (kg) / {Height (m)}^2*
5) Participants who can refrain from excessive exercise during the clinical study period.
6) Participants who can maintain a diet of three meals per day and avoid overeating and excessive drinking during the clinical study period.
7) Participants who can understand and comply with the management instructions during the clinical study period.
8) Participants deemed eligible by the principal investigator or equivalent based on a comprehensive assessment.
Key exclusion criteria - 1) Participants 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) Participants with a history of major surgery of the gastrointestinal tract, such as gastrectomy, gastrointestinal suture, or bowel resection (except polypectomy and appendectomy).
3) Participants with a history of cerebrovascular disease (except asymptomatic lacunar infarction).
4) Participants with food allergies or hypersensitivity related to the test food, or with specific constitutions.
5) Participants suspected of alcohol or drug abuse.
6) Participants who have participated in another clinical trial or study within 84 days prior to the date of consent.
7) Participants 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) Participants unable to refrain from consuming honey other than the test food during the study period.
9) Participants 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) Participants who wish to become pregnant or who are unable to use contraception during the clinical trial period.
11) Participants who are breastfeeding or pregnant.
12) Participants with irregular lifestyles due to night shifts or shift work.
13) Participants who live with someone who is participating or planning to participate in the study.
14) Any other participants deemed inappropriate for participation by the principal investigator.
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 23 Day
Anticipated trial start date - 2026 Year 02 Month 26 Day
Last follow-up date - 2026 Year 08 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069212
Disclaimer: Curated by HT Syndication.
