Clinical trial Recruiting at 1 site Interventional Ages 18 to 75 Men only

Lycopene to track dietary compliance in healthy men

Official title: Plasma Lycopene Concentration as a Dietary Compliance Biomarker - a Pilot Study

Run by Erasmus Medical Center · NCT07117110 · Data updated 2026-11-12

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.

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Quick facts

Study typeInterventional
Ages18 Years to 75 Years
SexMen only
Enrollment10 (estimated)
SponsorErasmus Medical Center
Academic / other
Locations1 site (Rotterdam)
StatusRecruiting
StartedJuly 11, 2025
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedAugust 12, 2025
Trial IDNCT07117110 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Erasmus MC
    Rotterdam, Netherlands
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.