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 range21 Years – 70 Years

SexALL

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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

What they're measuring

Reduction of postprandial Oxidized LDL(OX-LDL) levels following 2 weeks of supplementation with tomato extracted lycopene

Timeframe: Baseline and over 6 hours

Trial details

NCT IDNCT01665469

SponsorLycoRed Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-04

View on ClinicalTrials.gov More Postprandial Oxidation and inﬂammation trials