- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01665469
Effect of Tomato Extracted Lycopene on Postprandial Oxidation and inflammation in Healthy Weight Men and Women
December 21, 2017 updated by: LycoRed Ltd.
Effect of Tomato Extracted Lycopene on Postprandial Oxidation and inflammation in Healthy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tel-Aviv, Israel
- Tel Aviv Sourasky Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
- 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
- Subjects that smoke (past smokers are allowed if smoking was ceased > 2 years prior to study inclusion)
- Subjects that has high fasting serum triglyceride
- Subjects that has a diagnosis of type 1 or type 2 diabetes mellitus
- Subjects that has high serum thyroid-stimulating hormone
- Subjects that has aspartate aminotransferase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal
- Subjects that has Creatinine ≥ 1.5 mg/dl
- Subjects that has high-sensitivity C-reactive protein
- Woman subjects with positive pregnancy test
- Woman subjects that are breast feeding, pregnant, or planning on becoming pregnant during the duration of the study
- 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).
- Subject with history of significant gastrointestinal disease such as severe constipation, diarrhea, malabsorptive disease, inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
- Subject with history of severe psychiatric illness which in the opinion of the investigator would interfere with the optimal participation in the study
- Subject with history of bariatric surgery
- Subject with history or current use of illegal or "recreational" drugs
- Subject that used any investigational drug(s) 60 days prior to screening
- Subject that participate in any other clinical trial while participating in this trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
Soft gel capsule without test material
|
|
EXPERIMENTAL: Tomato extracted lycopene
Soft gel cups for oral use
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of postprandial Oxidized LDL(OX-LDL) levels following 2 weeks of supplementation with tomato extracted lycopene
Time Frame: Baseline and over 6 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between the anti-oxidation and anti-inflammation effects and serum lycopene, phytofluene and phytoene levels
Time Frame: Baseline and over 6 hours
|
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
|
Number of adverse events recorded during the supplementation period, lycopene compared to placebo
Time Frame: 2 weeks
|
safety measurements
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Zeltser, Prof', Tel Aviv Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2012
Primary Completion (ACTUAL)
April 1, 2013
Study Completion (ACTUAL)
June 1, 2013
Study Registration Dates
First Submitted
August 9, 2012
First Submitted That Met QC Criteria
August 14, 2012
First Posted (ESTIMATE)
August 15, 2012
Study Record Updates
Last Update Posted (ACTUAL)
December 22, 2017
Last Update Submitted That Met QC Criteria
December 21, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lyc-2012-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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