Lycopene as a Dietary Compliance Biomarker
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Supplement, Tomato soup.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 75 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Plasma Lycopene Concentration as a Dietary Compliance Biomarker - a Pilot Study
Overview
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.
Interventions
- Dietary supplement Supplement
Group will take 40 mg lycopene (2,5 pills of food supplement Vitabiotics Ultra Lycopene 15mg, potent extract). - Other Tomato soup
Group will take 250 ml of tomato soup (matching with 40 mg lycopene) with 20 ml olive oil.
Primary outcome measures
- 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 outcome measures (2)
- 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.]
- 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.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Netherlands · 1 center
- Erasmus MC — Rotterdam
Identifiers
NCT: NCT07117110 · MEC-2023-0633 · NL85468.078.23