Postprandial Oxidation and inflammationNCT01665469
Effect of Tomato Extracted Lycopene on Postprandial Oxidation and inflammation in Healthy Weight Men and Women
A study testing Tomato extracted lycopene in people with Postprandial Oxidation and inflammation, run by LycoRed Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Oxidation and inflammation
- What is being tested?
- Tomato extracted lycopene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postprandial Oxidation and inflammation
- Being tested
- Tomato extracted lycopene, Placebo
- Keywords
- anti oxidation, lycopene, Ox-LDL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tomato extracted lycopeneDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Soft gel capsule without test material Receives: Dietary Supplement: Placebo |
| Tomato extracted lycopene | Experimental | Soft gel cups for oral use Receives: Dietary Supplement: Tomato extracted lycopene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of postprandial Oxidized LDL(OX-LDL) levels following 2 weeks of supplementation with tomato extracted lycopene
Following two weeks of supplementation the evaluation will be done at baseline,before the high fat meal and during 6 hours following the meal.
Measured: Baseline and over 6 hours
Secondary outcomes (1)
Reduction of postprandial triglycerides, glucose, insulin and hsCRP levels following 2 weeks of supplementation with tomato extracted lycopene
Following two weeks of supplementation the evaluation will be done at baseline,before the high fat meal and during 6 hours following the meal.
Measured: Baseline and over 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial Oxidation and inflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- LycoRed Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Zeltser, Prof', Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665469
- Sponsor's protocol ID
- Lyc-2012-02
- Status last verified
- Dec 2017
- First submitted
- 9 Aug 2012
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tomato Extracted Lycopene on Postprandial Oxidation and inflammation in Healthy
- ClinicalTrials.gov ID
- NCT01665469
- Acronym / sponsor ID
- Lyc-2012-02
- Conditions
- Postprandial Oxidation and inflammation
- Keywords
- anti oxidation, lycopene, Ox-LDL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- LycoRed Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2012 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSoft gel capsule without test material |
| Tomato extracted lycopene | Experimental | Dietary Supplement: Tomato extracted lycopeneSoft gel cups for oral use |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tomato extracted lycopene | Dietary supplement | Tomato extracted lycopene |
| Placebo | Dietary supplement | Placebo |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Data on tomato extracted lycopeneLink provided by the sponsor.
Related trials for Postprandial Oxidation and inflammation
Recruiting
The Effects of Brown Rice Compared to White Rice on Postprandial Changes in IL-6 and MDA Levels in Sedentary Workers
Sedentary Employees, Postprandial Oxidation and inflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Zeltser, Prof' principal investigator
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tomato extracted lycopene in people with Postprandial Oxidation and inflammation, run by LycoRed Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of postprandial Oxidized LDL(OX-LDL) levels following 2 weeks of supplementation with tomato extracted lycopene (time frame: Baseline and over 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.