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NCT Number: NCT07117110

Lycopene as a Dietary Compliance Biomarker

Rationale: To determine the plasma lycopene concentration before and after an oral intake of lycopene in order to use this measurement as a life style compliance marker.

Objective: Primary objective: to determine if a plasma lycopene concentration can serve as a response parameter after a single dose of dietary lycopene.

Study design: Cross-over interventional pilot study.

Study population: Ten male healthy volunteers 18-75 years. Intervention: Oral food supplement tablet 40 mg lycopene once, versus oral soup of cooked tomatoes equivalent to 40 mg lycopene content. In addition, the participants' habitual diet and actual food intake during the intervention will be measured using a food frequency questionnaire and a food diary.

Main study parameters/endpoints: Variation of plasma lycopene 1 hour before, and 1,3,6,12,24,48,72 hours after intervention.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Eight blood samples of 6 ml full venous blood obtained by vena puncture per intervention per individual, 2 times in a cross-over pilot study, in which interventions are 3 weeks apart (so 2 x 8 samples in 10 volunteers). Risk of vena puncture is negligible, idemque the burden.

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Key information

Conditions

Healthy

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus MC

Rotterdam, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supplement

Dietary Supplement

Group will take 40 mg lycopene (2,5 pills of food supplement Vitabiotics Ultra Lycopene 15mg, potent extract).

Tomato soup

Other

Group will take 250 ml of tomato soup (matching with 40 mg lycopene) with 20 ml olive oil.

Primary outcomes

  1. To measure lycopene concentration after a single dose of dietary lycopene.

    Time frame: From enrollment until 72 hours after, wash out period of 3 weeks, then again start until 72 hours later.

Secondary outcomes

  1. To measure lycopene concentration after taking a food supplement tablet lycopene of 40mg of lycopene.

    Time frame: Start intervention until 72 hours later, wash-out period, start intervention until 72 hours later.

  2. To measure prior food consumption using a daily food questionnaire.

    Time frame: One week before the dietary intervention a daily food questionnaire will be completed.

Study contacts

Contact information is provided by the study sponsor or research team.

Lionne DF Venderbos

CONTACT

[email protected]

0031650001668

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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