Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-24 @ 11:09 PM
NCT ID:
NCT01665469
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT01665469
Study Brief:
Protocol Section:
NCT01665469