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The hypothesis of the study is that tomato extracted lycopene will be able to decrease postprandial oxidation and inflammation in healthy weight men and women when compared to Placebo.
Consumption of a high-fat meal results in a postprandial (fed-state) response characterized by hypertriglyceridemia. Postprandial hypertriglyceridemia increases the oxidation of low-density lipoproteins (LDL) and increases blood concentrations of several biomarkers of inflammation. This postprandial lipemia-induced oxidative stress mediated response to a high-fat meal has been suggested as a major contributor to the pathogenesis of atherosclerosis along with other chronic disease states of diabetes and obesity. Consumption of foods rich in antioxidant compounds provides a defence source to compliment endogenous defence systems to protect against oxidative damage during pro-oxidant conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Soft gel capsule without test material |
|
| Tomato extracted lycopene | Experimental | Soft gel cups for oral use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tomato extracted lycopene | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of postprandial Oxidized LDL(OX-LDL) levels following 2 weeks of supplementation with tomato extracted lycopene | Following two weeks of supplementation the evaluation will be done at baseline,before the high fat meal and during 6 hours following the meal. | Baseline and over 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of postprandial triglycerides, glucose, insulin and hsCRP levels following 2 weeks of supplementation with tomato extracted lycopene | Following two weeks of supplementation the evaluation will be done at baseline,before the high fat meal and during 6 hours following the meal. | Baseline and over 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the anti-oxidation and anti-inflammation effects and serum lycopene, phytofluene and phytoene levels | Following two weeks of supplementation the evaluation will be done at baseline,before the high fat meal and during 6 hours following the meal. | Baseline and over 6 hours |
| Number of adverse events recorded during the supplementation period, lycopene compared to placebo |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Zeltser, Prof' | Tel Aviv Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Sourasky Medical Center | Tel Aviv | Israel |
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| Label | URL |
|---|---|
| Data on tomato extracted lycopene | View source |
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| Dietary Supplement |
|
safety measurements |
| 2 weeks |