NCT07117110

Lycopene as a Dietary Compliance Biomarker

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-11
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-08-12
• Last updated: 2025-08-12

Locations

1 site across 1 country: Netherlands