Effect of Tomato Extracted Lycopene on Postprandial Oxidation and inflammation in Healthy Weight Men and Women

This study is currently recruiting participants.
Verified December 2012 by LycoRed Ltd.
Sponsor:
Information provided by (Responsible Party):
LycoRed Ltd.
ClinicalTrials.gov Identifier:
NCT01665469
First received: August 9, 2012
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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.

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.


Condition Intervention Phase
Postprandial Oxidation and inflammation
Dietary Supplement: Tomato extracted lycopene
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by LycoRed Ltd.:

Primary Outcome Measures:
  • Reduction of postprandial Oxidized LDL(OX-LDL) levels following 2 weeks of supplementation with tomato extracted lycopene [ Time Frame: Baseline and over 6 hours ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Reduction of postprandial triglycerides, glucose, insulin and hsCRP levels following 2 weeks of supplementation with tomato extracted lycopene [ Time Frame: Baseline and over 6 hours ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Correlation between the anti-oxidation and anti-inflammation effects and serum lycopene, phytofluene and phytoene levels [ Time Frame: Baseline and over 6 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Soft gel capsule without test material
Dietary Supplement: Placebo
Experimental: Tomato extracted lycopene
Soft gel cups for oral use
Dietary Supplement: Tomato extracted lycopene

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665469

Contacts
Contact: David Zeltser, Prof' +972-3-6973313 davidz@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel
Contact: David Zeltser,, Prof'    +972-3-6973313    davidz@tasmc.health.gov.il   
Principal Investigator: David Zeltser, Prof'         
Sponsors and Collaborators
LycoRed Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: LycoRed Ltd.
ClinicalTrials.gov Identifier: NCT01665469     History of Changes
Other Study ID Numbers: Lyc-2012-02
Study First Received: August 9, 2012
Last Updated: December 19, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by LycoRed Ltd.:
anti oxidation
lycopene
Ox-LDL

Additional relevant MeSH terms:
Lycopene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014