Effect of Tomato Extracted Lycopene on Postprandial Oxidation and inflammation in Healthy Weight M… (NCT01665469) | Clinical Trial Compass
CompletedNot Applicable
Effect of Tomato Extracted Lycopene on Postprandial Oxidation and inflammation in Healthy Weight Men and Women
Israel30 participantsStarted 2012-11
Plain-language 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.
Who can participate
Age range
21 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction of postprandial Oxidized LDL(OX-LDL) levels following 2 weeks of supplementation with tomato extracted lycopene
. 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