Lycopene as a Dietary Compliance Biomarker

NCT07117110 | Recruiting

• 2 other identifiers: MEC-2023-0633NL85468.078.23
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lycopene; life style; healthy; male; prostate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (2)

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.

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).

Dietary Supplement: Supplement; Other: Tomato soup

Interventions

Supplement DIETARY_SUPPLEMENT

Group will take 40 mg lycopene (2,5 pills of food supplement Vitabiotics Ultra Lycopene 15mg, potent extract).

Group A - supplement, tomato soup; Group B - tomato soup, supplement

Tomato soup OTHER

Group will take 250 ml of tomato soup (matching with 40 mg lycopene) with 20 ml olive oil.

Group A - supplement, tomato soup; Group B - tomato soup, supplement

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Males by birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male;
• Healthy;
• yrs old.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

RECRUITING

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Lionne DF Venderbos

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lionne DF Venderbos

CONTACT

0031650001668; l.venderbos@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 12, 2025
• Study Start: July 11, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)