Effect of Tomato Extracted Lycopene on Postprandial Oxidation and inflammation in Healthy Weight Men and Women

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.

Inclusion criteria

• Male or female
• Age: 21 - 70 years both inclusive
• Subject with Body Mass Index: 19- 25 kg/m2 both inclusive
• Subject with Fasting serum LDL-cholesterol: ≥ 100 mg/dL and < 200 mg/dL
• Subject with High-sensitivity C-reactive protein (hsCRP) < 1.0 mg/L
• Subject is willing to take supplement once daily for 4 weeks and undergo other study-related procedures
• Subject is otherwise is in general good health as determined by the principal investigator
• Subjects is willing to sign an informed consent form prior to joining the study

Exclusion criteria

• Subjects suffering from overweight defined as BMI > 25 kg/m2
• Subject that is actively losing weight (e.g. are on a diet) or subjects with greater than 5% change in body weight within 1 month prior to the randomization visit
• Subject taking lipid-altering drug therapy within six weeks prior to screening. Also excluded are supplements known to have significant lipid altering effects, such as niacin, garlic, omega-3 fatty acids, red yeast rice extract, phytostanols / phytosterols, soluble fiber, chitosan and conjugated linoleic acid
• Subjects using the following medications: systemic corticosteroids, orlistat, bile acid resins, prescription omega-3 fatty acids, cyclical or non-continuous hormone therapy
• Subjects that use antioxidant agents or vitamins within 6 weeks prior to inclusion into the study. For subject using vitamin supplementation a 6 week wash out will be required prior to inclusion into the study.
• Subjects that will not be able to follow dietary proscriptions from the screening visit through the final visit
• Subjects following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc.
• Subjects with known allergy to tomato, carotenoids, or vitamin E
• Subjects that smoke (past smokers are allowed if smoking was ceased > 2 years prior to study inclusion)
• Subjects that has high fasting serum triglyceride
• Subjects that has a diagnosis of type 1 or type 2 diabetes mellitus
• Subjects that has high serum thyroid-stimulating hormone
• Subjects that has aspartate aminotransferase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal
• Subjects that has Creatinine ≥ 1.5 mg/dl
• Subjects that has high-sensitivity C-reactive protein
• Woman subjects with positive pregnancy test
• Woman subjects that are breast feeding, pregnant, or planning on becoming pregnant during the duration of the study
• Subjects with known cardiovascular disease or stroke, except for conditions that are deemed clinically insignificant by Principle Investigator or Sub-investigator, or study site physician (e.g. clinically insignificant atherosclerotic lesions observed by imaging studies).
• Subject with history of significant gastrointestinal disease such as severe constipation, diarrhea, malabsorptive disease, inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
• Subject with history of severe psychiatric illness which in the opinion of the investigator would interfere with the optimal participation in the study
• Subject with history of bariatric surgery
• Subject with history or current use of illegal or "recreational" drugs
• Subject that used any investigational drug(s) 60 days prior to screening
• Subject that participate in any other clinical trial while participating in this trial