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The evaluation of the absorption of lycopene derived from processed tomato extract compared to natural tomato extract -A Randomized, Double-blind, Placebo-controlled Crossover trial-

The evaluation of the absorption of lycopene derived from processed tomato extract compared to natural tomato extract -A Randomized, Double-blind, Placebo-controlled Crossover trial- - The evaluation of the absorption of lycopene derived from processed tomato extract

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000037435
Enrollment
30
Registered
2020-07-17
Start date
2019-07-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None(Healthy subjects)

Interventions

single ingestion of the natural extract - washout period(6 days or more)- single ingestion of the processed extract single ingestion of the processed extract - washout period(6 days or more)- single i

Sponsors

Shiba Palace Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Japanese males and females from 20 to 59 years old when the consent is obtained 2)Healthy participants 3)Subjects who can be collected their blood multiple times(6 times per day) 4)Subjects with the normal fasting serum triglyceride value and LDL-cholesterol value

Exclusion criteria

Exclusion criteria: 1)Subjects who are pregnant. 2)Smokers. 3)Subjects with a history of cancers or gastrointestinal diseases (except appendicitis). 4)Subjects who take the medicine related to lipids absorption. 5)Subjects who take the same medicine habitually. 6)Subjects with diseases such as autoimmune diseases, chronic inflammatory diseases and the diabetes mellitus. 7)Subjects who take the excessive alcohol(equivalent alcohol to 633 mL of beer or more at least 5 days a week). 8)Subjects who participate in another clinical trial. 9)Subjects with serious anemia. 10)Subjects who donated 200 mL or 400 mL whole blood or were transfused within 3 months before the screening.

Design outcomes

Primary

MeasureTime frame
Comparison of the serum lycopene concentration at each sampling point and AUC 0-12h of lycopene after intake of processed tomato extract with normal tomato extract(The analysis of actual measured values and the amount of changes values from baseline after the loading tomato extracts).

Countries

Japan

Contacts

Public ContactYoshiyuki Shirakura

FUJIFILM Healthcare Laboratory Co., Ltd. Department of Supplement product management

yoshiyuki.shirakura@fujifilm.com042-339-8926

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026