Healthy
Conditions
Keywords
lycopene, life style, healthy, male, prostate
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.
Interventions
DIETARY_SUPPLEMENTSupplement
Group will take 40 mg lycopene (2,5 pills of food supplement Vitabiotics Ultra Lycopene 15mg, potent extract).
OTHERTomato soup
Group will take 250 ml of tomato soup (matching with 40 mg lycopene) with 20 ml olive oil.
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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
| 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. |
Countries
Netherlands
Contacts
Primary ContactLionne DF Venderbos
Outcome results
None listed