Effect of Tomato Extracted Lycopene on Postprandial Oxidation and inflammation in Healthy Weight Men and Women
NCT ID: NCT01665469
Last Updated: 2017-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2012-11-30
2013-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Soft gel capsule without test material
Placebo
Tomato extracted lycopene
Soft gel cups for oral use
Tomato extracted lycopene
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tomato extracted lycopene
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
21 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
LycoRed Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Zeltser, Prof'
Role: PRINCIPAL_INVESTIGATOR
Tel Aviv Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Data on tomato extracted lycopene
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Lyc-2012-02
Identifier Type: -
Identifier Source: org_study_id