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Lycopene as a Dietary Compliance Biomarker

RecruitingNAAges 18 Years - 75 YearsMaleErasmus Medical Center
NCT07117110 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 an

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📋 Eligibility rules (as published)
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.
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What it tests

  • Supplement
  • Tomato soup
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Where

1 site
Erasmus MC
Rotterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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