Lycopene as a Dietary Compliance Biomarker

Erasmus University

Status: Enrolling

Conditions: Healthy

Treatments: Other: Tomato soup; Dietary Supplement: Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT07117110

MEC-2023-0633

NL85468.078.23 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Group A - supplement, tomato soup

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Supplement

Other: Tomato soup

Group B - tomato soup, supplement

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Supplement

Other: Tomato soup