Primary objective: to determine if a plasma lycopene concentration can serve as a response parameter after a single dose of dietary lycopene.
ID
Source
Brief title
Synonym
Health condition
Geen specifieke aandoening. We zijn benieuwd of lycopeen als een life style compliance marker zou kunnen dienen.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Raise of plasma lycopene concentration in absolute (ng/ml) and relative
(percentage of T0-value) after single lycopene intervention.
Secondary outcome
1. Optimal time point of lycopene concentration response after single dietary
intervention (hours, days).
2. Influence of prior food consumption on plasma lycopene levels before and
after lycopene interventions, as measured by dietary questionnaires.
Background summary
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.
Study 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.
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.
Study burden and risks
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.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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 (e.g., vegan);
• 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85468.078.23 |