Postprandial Oxidation and in?ammation Clinical Trial
Official title:
Effect of Tomato Extracted Lycopene on Postprandial Oxidation and inflammation in Healthy
| Verified date | December 2017 |
| Source | LycoRed Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | June 2013 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 21 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Tel Aviv Sourasky Medical Center | Tel-Aviv |
| Lead Sponsor | Collaborator |
|---|---|
| LycoRed Ltd. |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Correlation between the anti-oxidation and anti-in?ammation 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 | |
| Other | Number of adverse events recorded during the supplementation period, lycopene compared to placebo | safety measurements | 2 weeks | |
| Primary | 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 | |
| Secondary | 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 |