HealthyNCT07117110
Lycopene as a Dietary Compliance Biomarker
A study testing Supplement and Tomato soup in people with Healthy, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Supplement and Tomato soup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Jul 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male;
- Healthy;
- 18-75 yrs old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Plasma Lycopene Concentration as a Dietary Compliance Biomarker - a Pilot Study
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.
Read more
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.
- Conditions
- Healthy
- Being tested
- Supplement, Tomato soup
- Keywords
- lycopene, life style, healthy, male, prostate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupplementDietary supplement
Group will take 40 mg lycopene (2,5 pills of food supplement Vitabiotics Ultra Lycopene 15mg, potent extract).
Tomato soupOther
Group will take 250 ml of tomato soup (matching with 40 mg lycopene) with 20 ml olive oil.
| Study group | Role | What they receive |
|---|---|---|
| Group A - supplement, tomato soup | Experimental | Group A will take 40 mg lycopene (2,5 pills of food supplement Vitabiotics Ultra Lycopene 15mg, potent extract) first. After a wash-out period, group A will continue and take 250ml of tomato soup (matching with 40mg lycopene) with 20ml olive oil. Receives: Dietary Supplement: Supplement; Other: Tomato soup |
| Group B - tomato soup, supplement | Experimental | Group B will take 250 ml of tomato soup (matching with 40 mg lycopene) with 20 ml olive oil first. After a wash-out period, group B will continue and take 40mg lycopene (2,5 pills of food supplement Vitabiotics Ultra Lycopene 15mg, potent extract). Receives: Dietary Supplement: Supplement; Other: Tomato soup |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure lycopene concentration after a single dose of dietary lycopene.
Measured: From enrollment until 72 hours after, wash out period of 3 weeks, then again start until 72 hours later.
Secondary outcomes (2)
To measure lycopene concentration after taking a food supplement tablet lycopene of 40mg of lycopene.
Measured: 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.
Measured: One week before the dietary intervention a daily food questionnaire will be completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start11 Jul 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lionne Venderbos, Erasmus Medical Center
- Investigators
- Lionne DF Venderbos, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117110
- Sponsor's protocol ID
- MEC-2023-0633
- Other IDs
- NL85468.078.23
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Lycopene Concentration as a Dietary Compliance Biomarker - a Pilot Study
- ClinicalTrials.gov ID
- NCT07117110
- Acronym / sponsor ID
- MEC-2023-0633
- Conditions
- Healthy
- Keywords
- lycopene, life style, healthy, male, prostate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - supplement, tomato soup | Experimental | Dietary Supplement: Supplement, Other: Tomato soupGroup A will take 40 mg lycopene (2,5 pills of food supplement Vitabiotics Ultra Lycopene 15mg, potent extract) first. After a wash-out period, group A will continue and take 250ml of tomato soup (matching with 40mg lycopene) with 20ml olive oil. |
| Group B - tomato soup, supplement | Experimental | Dietary Supplement: Supplement, Other: Tomato soupGroup B will take 250 ml of tomato soup (matching with 40 mg lycopene) with 20 ml olive oil first. After a wash-out period, group B will continue and take 40mg lycopene (2,5 pills of food supplement Vitabiotics Ultra Lycopene 15mg, potent extract). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male;
- Healthy;
- 18-75 yrs old.
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SupplementGroup will take 40 mg lycopene (2,5 pills of food supplement Vitabiotics Ultra Lycopene 15mg, potent extract). | Dietary supplement | Group A - supplement, tomato soup, Group B - tomato soup, supplement |
| Tomato soupGroup will take 250 ml of tomato soup (matching with 40 mg lycopene) with 20 ml olive oil. | Other | Group A - supplement, tomato soup, Group B - tomato soup, supplement |
Primary outcome
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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lionne DF Venderbos principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement and Tomato soup in people with Healthy, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lionne DF Venderbos (0031650001668, l.venderbos@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.