Healthy adults
Conditions
Interventions
Daily ingestion of 16 tablets (3.2g freeze dried sea urchin'
s gonads/day) for 12 weeks.
Daily ingestion of 16 placebo tablets for 12 weeks.
Sponsors
Hokkaido Information University
Graduate School of Fisheries Sciences, National University Corporation Hokkaido University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects whose BMI is>=23 kg/m2 and <30 kg/m2. 2. Subjects who agree to participate in this study with a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects who are under physician's advice, treatment and/or medication for obese, hyperlipidemia and diabetes. 2. Subjects whose BMI is >=30 kg/m2. 3. Subjects with familial hypercholesterolemia. 4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 5. Subjects who use pacemaker or defibrillator. 6. Subjects with major surgical history relevant to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 7. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 8. Subjects with severe anemia. 9. Pre- or post-menopausal women complaining obvious physical changes. 10. Subjects who are at risk of having allergic reactions to drugs or foods based on especially sea urchin and salmon roe. 11. Subjects who regularly take drugs, functional foods, and/or supplements which would affect BW and BFP. 12. Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood lipid levels. 13. Subjects who regularly take medicine, functional foods and/or supplements which would affect glucose metabolism. 14. Heavy smokers, alcohol addicts or subjects with the eating disordered lifestyle. 15. Subjects who donated either 400ml whole blood within 16 weeks (women) /12 weeks (men) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to the current study. 16. Pregnant or lactating women or women expect to be pregnant during this study. 17. Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study. 18. Any other medical and/ or health reasons unfavorable to participation into the current study judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal visceral fat area after 6 and 12 weeks of ingestion | — |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal total fat area, abdominal subcutaneous fat area, body weight, BFP, BMI, waist circumference, hip circumference, waist-hip ratio, BP measured at the hospital, TC, LDL-C, HDL-C, TG, fasting blood glucose levels, HbA1c, adiponectin, leptin and VAS questionnaire | — |
Countries
Japan
Contacts
Public ContactDir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Hokkaido Information University Health Information Science Center
Outcome results
None listed