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| ID | Type | Description | Link |
|---|---|---|---|
| NL85468.078.23 | Other Identifier | Erasmus MC |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplement | Dietary Supplement | Group will take 40 mg lycopene (2,5 pills of food supplement Vitabiotics Ultra Lycopene 15mg, potent extract). |
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| Measure | Description | Time Frame |
|---|---|---|
| To measure lycopene concentration after a single dose of dietary lycopene. | From enrollment until 72 hours after, wash out period of 3 weeks, then again start until 72 hours later. |
| Measure | Description | Time Frame |
|---|---|---|
| To measure lycopene concentration after taking a food supplement tablet lycopene of 40mg of lycopene. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Males by birth.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lionne DF Venderbos | Contact | 0031650001668 | l.venderbos@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Lionne DF Venderbos | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Recruiting | Rotterdam | Netherlands |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2025 | Aug 4, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Tomato soup | Other | Group will take 250 ml of tomato soup (matching with 40 mg lycopene) with 20 ml olive oil. |
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| One week before the dietary intervention a daily food questionnaire will be completed. |