Lycopene to track dietary compliance in healthy men

Plasma Lycopene Concentration as a Dietary Compliance Biomarker - a Pilot Study

This tests whether a single 40 mg dose of lycopene from a supplement or from tomato soup raises blood lycopene in healthy men so it can be used to track diet compliance.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Male
• Sponsor: Erasmus Medical Center (Academic / other)
• Locations: 1 site (Rotterdam)
• Trial ID: NCT07117110 on ClinicalTrials.gov

What this trial studies

This crossover pilot enrolls ten healthy men aged 18–75 who each receive a single 40 mg oral dose of lycopene as a supplement tablet and, on a separate occasion, an equivalent amount in cooked tomato soup. Blood samples are taken one hour before and at 1, 3, 6, 12, 24, 48 and 72 hours after each intervention to measure plasma lycopene concentrations. Participants complete a food frequency questionnaire and keep a food diary to document habitual intake and intake during the intervention. The study examines whether the single-dose plasma response is consistent and large enough to serve as a practical compliance marker for dietary lycopene intake.

Who should consider this trial

Good fit: Healthy men aged 18–75 without recent gastrointestinal disorders, not using medications or supplements that affect absorption, not smoking, and not following a restrictive diet are ideal candidates.

Not a fit: Women, children, people with a tomato allergy, those with recent GI disease, heavy smokers, or people on medications/supplements that alter fat or carotenoid absorption are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could provide a simple blood marker to confirm whether participants consumed lycopene-containing foods or supplements in nutrition studies.

How similar studies have performed: Previous research shows plasma lycopene increases after tomato consumption and supplementation, but using a single-dose plasma response as a compliance biomarker is a novel, pilot-level approach.

Eligibility criteria

Inclusion Criteria:

* Male;
* Healthy;
* 18-75 yrs old.

Exclusion Criteria:

* Allergic for tomatoes;
* Any gastrointestinal disorder within 3 months prior to the intervention;
* Recent medication or supplement use;
* Recent substantial change in weight;
* Adherence to a specific diet ( for example the Moorman-diet);
* Using recreational drugs more than once a month;
* Smoking and excessive alcohol consumption (\>10 standardized glasses a week).
* Risk of a dependency situation with the researchers.

Where this trial is running

Rotterdam

• Erasmus MC — Rotterdam, Netherlands (Recruiting)

Study contacts

• Principal investigator: Lionne DF Venderbos — Erasmus Medical Center
• Study coordinator: Lionne DF Venderbos

Conditions Healthy; lycopene; life style; healthy; male; prostate