moderately high body mass index (24-30 kg/m2) with 100-250 mg/dL serum triglycerid, healthy subjects
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: [1]20-65 years old male and female [2]serum triglyceride:100-250 mg/dL [3]body mass index(BMI):24-30 kg/m2
Exclusion criteria
Exclusion criteria: [1]Subjects with drug or food allergy [2]Subjects with a serious history in liver, kidney, heart, lung, or gastrointestinal (including gastric resection, except for the cecum resection) [3]Subjects who donated 400 mL blood within 12 weeks, 200 mL within 4 weeks, or plasmapheresis within 2 weeks before starting of ingestion [4]Subjects whose systolic blood pressure value are less than 90 mmHg [5]Heavy users of alcohol, heavy smokers [6]Subjects with extremely irregular eating habit, shifts workers, late-night workers [7]Subjects taking medication or functional foods, influencing the results of this study, such as medicine, foods for specified health use, health foods. [8]Subjects who drink a lot of drink containing caffeine (tea, coffee, Coke, etc) [9]Female subjects who wish to become pregnant during the study period, (including the case who is suspected of being pregnant), or are pregnant or in nursing. [10]Subjects participating in another study or finished prior study within 4 weeks [11]Subjects deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal fat area (subcutaneous fat area and visceral fat area) at 0 and 12-week ingestion period | — |
Secondary
| Measure | Time frame |
|---|---|
| At 0, 4, 8 and 12-week ingestion period [1]serum triglyceride [2]body weight [3]body mass index (BMI) | — |
Countries
Japan
Contacts
House Wellness Foods Corporation Research and Development Institute