Lycopene as a Dietary Compliance Biomarker

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.

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 Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Supplement; Other: Tomato soup

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lionne DF Venderbos; Phone Number: 0031650001668; Email: l.venderbos@erasmusmc.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A - supplement, tomato soup; 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.	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.
Experimental: Group B - tomato soup, supplement; 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	One week before the dietary intervention a daily food questionnaire will be completed.

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Lionne DF Venderbos, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 25, 2025
• First Submitted That Met QC Criteria: August 4, 2025
• First Posted (Actual): August 12, 2025

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: male; healthy; prostate; lycopene; life style
• Other Study ID Numbers: MEC-2023-0633; NL85468.078.23 (Other Identifier: Erasmus MC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No