Postprandial Oxidation and inflammation
Conditions
Keywords
anti oxidation, lycopene, Ox-LDL
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTTomato extracted lycopene
DIETARY_SUPPLEMENTPlacebo
Sponsors
LycoRed Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female 2. Age: 21 - 70 years both inclusive 3. Subject with Body Mass Index: 19- 25 kg/m2 both inclusive 4. Subject with Fasting serum LDL-cholesterol: ≥ 100 mg/dL and \< 200 mg/dL 5. Subject with High-sensitivity C-reactive protein (hsCRP) \< 1.0 mg/L 6. Subject is willing to take supplement once daily for 4 weeks and undergo other study-related procedures 7. Subject is otherwise is in general good health as determined by the principal investigator 8. Subjects is willing to sign an informed consent form prior to joining the study
Exclusion criteria
1. Subjects suffering from overweight defined as BMI \> 25 kg/m2 2. 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 3. 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 4. Subjects using the following medications: systemic corticosteroids, orlistat, bile acid resins, prescription omega-3 fatty acids, cyclical or non-continuous hormone therapy 5. 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. 6. Subjects that will not be able to follow dietary proscriptions from the screening visit through the final visit 7. Subjects following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc. 8. Subjects with known allergy to tomato, carotenoids, or vitamin E 9. Subjects that smoke (past smokers are allowed if smoking was ceased \> 2 years prior to study inclusion) 10. Subjects that has high fasting serum triglyceride 11. Subjects that has a diagnosis of type 1 or type 2 diabetes mellitus 12. Subjects that has high serum thyroid-stimulating hormone 13. Subjects that has aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 3 times the upper limit of normal 14. Subjects that has Creatinine ≥ 1.5 mg/dl 15. Subjects that has high-sensitivity C-reactive protein 16. Woman subjects with positive pregnancy test 17. Woman subjects that are breast feeding, pregnant, or planning on becoming pregnant during the duration of the study 18. 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). 19. Subject with history of significant gastrointestinal disease such as severe constipation, diarrhea, malabsorptive disease, inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) 20. Subject with history of severe psychiatric illness which in the opinion of the investigator would interfere with the optimal participation in the study 21. Subject with history of bariatric surgery 22. Subject with history or current use of illegal or recreational drugs 23. Subject that used any investigational drug(s) 60 days prior to screening 24. Subject that participate in any other clinical trial while participating in this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of postprandial Oxidized LDL(OX-LDL) levels following 2 weeks of supplementation with tomato extracted lycopene | Baseline and over 6 hours | Following two weeks of supplementation the evaluation will be done at baseline,before the high fat meal and during 6 hours following the meal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of postprandial triglycerides, glucose, insulin and hsCRP levels following 2 weeks of supplementation with tomato extracted lycopene | Baseline and over 6 hours | Following two weeks of supplementation the evaluation will be done at baseline,before the high fat meal and during 6 hours following the meal. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation between the anti-oxidation and anti-inflammation effects and serum lycopene, phytofluene and phytoene levels | Baseline and over 6 hours | Following two weeks of supplementation the evaluation will be done at baseline,before the high fat meal and during 6 hours following the meal. |
| Number of adverse events recorded during the supplementation period, lycopene compared to placebo | 2 weeks | safety measurements |
Countries
Israel
Outcome results
None listed