N/A (healthy adults)
Conditions
Interventions
Intake the test food (capsules containing ellagic acid) for 12 weeks
Intake the control food (capsules without ellagic acid) for 12 weeks
Sponsors
Kyowa Trial Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese males and females between the ages of 20 and less than 65 at the time of obtaining consent to participate in the test 2)Healthy persons who are not currently being treated for any illness 3)Those who have a BMI of 25 or more but less than 30 (Level 1 Obesity) at screening 4)Those who can visit the designated facility on the scheduled visit date 5)Those who fully understand the purpose and content of this test and have agreed in writing
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal visceral fat area (VFA) and amount of change | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMegumi Takahashi
Ryusendo Co., Ltd. Development Division
Outcome results
None listed