Tokyo, March 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061067) titled 'Safety Confirmation Study on long-term of Supplement Containing Bee Larva in Healthy Subjects' on March 27.
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 (4 capsules/day for 12 weeks) of a capsule-type supplement containing mainly honeybee larvae and a small amount of royal jelly in healthy adult men and women. Additionally, metabolome analysis will be conducted to explore the potential functionality of this supplement.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Capsule-type supplement containing bee larva and trace amounts of royal jelly ingredients
Intake amount: 4 grains/day
Intake duration: 84 days
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Healthy Japanese subjects between the ages of 20 and 45 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.
Key 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 a history of food allergies or asthma.
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 who are pregnant, planning to become pregnant during the study period, or breastfeeding.
9) Subjects with irregular lifestyles due to night shifts or shift work.
10) Subjects who live with someone who is participating or planning to participate in the study.
11) Subjects who are unable to comply with management requirements during the study period.
12) Any other subjects deemed inappropriate for participation by the principal investigator.
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 11 Day
Date of IRB - 2026 Year 03 Month 24 Day
Anticipated trial start date - 2026 Year 04 Month 27 Day
Last follow-up date - 2027 Year 01 Month 15 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069876
Disclaimer: Curated by HT Syndication.
