Trial of efficacy of ellagic acid in Japanese

UMIN ID: UMIN000050954

Registered date:10/09/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: N/A (healthy adults)
• Date of first enrollment: 2023/05/09
• Target sample size: 94
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intake the test food (capsules containing ellagic acid) for 12 weeks
Intake the control food (capsules without ellagic acid) for 12 weeks

Outcome(s)

• Primary Outcome: Abdominal visceral fat area (VFA) and amount of change
• Secondary Outcome: 1)Abdominal subcutaneous fat area (SFA) and amount of change 2)Abdominal total fat area (TFA) and amount of change 3)Body fat ratio and amount of change 4)Triglycerides and amount of change 5)Body weight and amount of change 6)BMI and amount of change 7)Waist circumference and amount of change 8)Hip circumference and amount of change

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1)Those who have difficulty to participate in this study because of conditions i.e., liver, kidney, or cardiac disease, breathing, endocrinology, metabolism, nervous, or conscious disorder, diabetes (determined by JDA), and other diseases 2)Those with history of cardiovascular diseases 3)Those who take drugs to improve glucose metabolism, lipid metabolism, or blood pressure 4)Those who use medicines, health foods and supplements (including "Food for specified health uses", "Foods with function claims" and "Food with nutrient function claims") constantly, excepting those who can stop them at taking of informed consent 5)Those who have allergies related to test food 6)Previous experience of poor or worsened health after giving a blood sample 7)Those who have donated at least 200 mL of blood from 3 months prior to the start of the test to the start of the test, or those who plan to do so during the test period 8)Participating in another clinical trial or within 4 weeks of completion of the trial 9)Heavy alcohol drinkers and excessive smokers 10)Those with extremely irregular eating habits 11)Those who wish to become pregnant, pregnant women (including those who may be pregnant), or lactating mothers during the study period 12)Those who do not agree with the purpose of the explanation of this examination given prior to the examination 13)Those who are deemed by the investigator to be inappropriate to participate in this study

Related Information

• Primary Sponsor: Kyowa Trial Co., Ltd.
• Source(s) of Monetary Support: Ryusendo Co., Ltd.