Healthy adults
Conditions
Interventions
for 8 weeks.
Daily ingestion of 50 g semi-dried tomato of placebo tomato (lycopene-free tomato) for 8 weeks.
Sponsors
Hokkaido Information University
TAKII &
COMPANY, LIMITED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects whose LDL-C is >=120 mg/dl and <160 mg/dl. 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 dyslipidemia, diabetes, and/or obesity. 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 with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 6. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 7. Subjects with severe anemia. 8. Pre- or post-menopausal women complaining of obvious physical changes. 9. Subjects who are at risk of having allergic reactions to drugs or foods especially based on tomato, Japanese cedar, Japanese cypress, or grass. 10. Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood lipid levels. 11. Subjects who regularly take medicine, functional foods, and/or supplements which would affect glucose metabolism. 12. Subjects who regularly take drugs, functional foods, and/or supplements which would affect BW and BFP. 13. Smokers. 14. Alcohol addicts or subjects with eating disordered lifestyle. 15. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study. 16. Pregnant or lactating women or women who 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 in the current study, as judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TC, LDL-C, HDL-C, TG, LDL-C/HDL-C, and non-HDL at 4 and 8 weeks after beginning the ingestion of test food. | — |
Secondary
| Measure | Time frame |
|---|---|
| serum lycopene, serum alpha-carotene, serum beta-carotene, serum vitamin A, MDA-LDL, serum-LPO, urinary isoprostane, urinary HEL, LOX-index, sLOX-1, LAB, visceral fat area (using impedance methods), abdominal subcutaneous fat area (using impedance methods), abdominal fat area (using impedance methods), body weight, body fat percentage, BMI, waist, FPG, HbA1c, blood pressure, POMS 2 full-length versions for adults, VAS questionnaire assessed fatigue, stress etc. | — |
Countries
Japan
Contacts
Public ContactDir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Hokkaido Information University Health Information Science Center
Outcome results
None listed