Healthy adults
Conditions
Interventions
for 12 weeks.
Daily ingestion of 50 g semi-dried tomato of placebo tomato (lycopene-free tomato) for 12 weeks.
Sponsors
Hokkaido Information University
TAKII &
COMPANY, LIMITED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent. 2.Subjects whose LDL-C is >=120 mg/dl and <160 mg/dl.
Exclusion criteria
Exclusion criteria: 1. Subject who participated in the pilot study. 2. Subjects who usually do not intake raw tomatoes. 3. Subjects who usually intake tomato juice. 4. Subjects who are under physician's advice, treatment, and/or medication for dyslipidemia and/or diabetes. 5. Subjects whose BMI is >=30 kg/m2. 6. Subjects with familial hypercholesterolemia. 7. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 8. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 9. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 10. Subjects with severe anemia. 11. Pre- or post-menopausal women complaining of obvious physical changes. 12. Subjects who are at risk of having allergic reactions to drugs or foods especially based on tomato, Japanese cedar, Japanese cypress, or grass. 13. Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood lipid levels. 14. Subjects who regularly take medicine, functional foods, and/or supplements which would affect glucose metabolism. 15. Alcohol addicts or subjects with eating disordered lifestyle. 16. 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. 17. Pregnant or lactating women or women who expect to be pregnant during this study. 18. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 19. 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 |
|---|---|
| LDL-C at 4, 8 and 12 weeks after beginning the ingestion of test food. | — |
Secondary
| Measure | Time frame |
|---|---|
| TC, HDL-C, TG, LDL/HDL ratio, non-HDL, serum lycopene, serum beta-carotene, adiponectin, MDA-LDL, LOX-index, sLOX-1, LAB, serum-LPO, salivary volume, salivary chromogranin A, VAS questionnaire assessed fatigue and stress, POMS-2 full-length versions for adults | — |
Countries
Japan
Contacts
Public ContactJun NISHIHIRA
Hokkaido Information University Health Information Science Center
Outcome results
None listed