Effect of Daily Ingestion of High-Lycopene Tomato "PR-7" on Lipid Metabolism for 12 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

Not Applicable

• Conditions: Healthy adults

• Registration Number: JPRN-UMIN000031975
• Lead Sponsor: Hokkaido Information University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-29
• Study Completion: 2018-09-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified