Lycopene as a Dietary Compliance Biomarker

Erasmus Medical Center10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

To measure lycopene concentration after a single dose of dietary lycopene.

Time frame: From enrollment until 72 hours after, wash out period of 3 weeks, then again start until 72 hours later.

Secondary Outcomes

To measure lycopene concentration after taking a food supplement tablet lycopene of 40mg of lycopene.

Time frame: 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.

Time frame: One week before the dietary intervention a daily food questionnaire will be completed.