Lycopene as a Dietary Compliance Biomarker

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-11

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Supplement

Intervention Type DIETARY_SUPPLEMENT

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

Tomato soup

Intervention Type OTHER

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

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).

Group Type EXPERIMENTAL

Supplement

Intervention Type DIETARY_SUPPLEMENT

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

Tomato soup

Intervention Type OTHER

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

Interventions

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Supplement

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

Intervention Type DIETARY_SUPPLEMENT

Tomato soup

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes