Clinical Trial: Evaluation of Antioxidant Activity of Oral Lutein in Preterm and Term Newborn

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Antioxidant Activity of Oral Lutein in Preterm and Term Newborn

Brief Summary:

The balance of the redox state is important for normal embryonic and fetal development . During the perinatal period, a variety of conditions are responsible for an excessive production of free radicals. The following oxidative stress is exacerbated by a lack of antioxidant substances that have not yet matured. At the moment there are no therapeutic strategies with single or combined antioxidants that have been shown to be clinically effective.

Breastfeeding is important for the contribution of the antioxidant defenses of the newborn and the nutritional status of the mother plays a key role because it influences the nutritional status of the newborn. Lutein is a carotenoid that is not produced by the body , but taken with food or supplements. The molecule carries out different activities : antioxidant, anti-inflammatory, anticancer , neuroprotective. Its main activity of inhibition of peroxidation of membrane lipids is peculiarly important for the photoreceptors and neurons whose membranes are rich with polyunsaturated fatty acids. Current evidence on its role as an antioxidant indicate that supplementation with lutein may play a significant role in the prevention of free radical disease in the newborn

Detailed Summary:

In recent years many scientific studies demonstrated that lutein, a nutrient belonging to the family of carotenoids, may constitute a valid and important preventive and protective factor against a large number of chronic diseases affecting millions of people around the world . Studies from literature highlight and confirm that lutein is able to reduce the risk of developing some ocular diseases or slow down their progression. Lutein is a fat-soluble derivative of polar hydroxylated xanthophyll which belongs to the family of carotenoids. Carotenoids are linear polyenes, ie double bonds conjugated hydrocarbons containing 40 atoms of carbon. Today there are 35 known carotenoids that are ingested, absorbed, metabolised and found in human serum. Lutein is the most important corotenoid and it is only in the retina, in the macula and in the lens. In tissues and serum lutein is found together with its isomer, the zeaxanthin. Lutein, commonly ingested with other foods, is partially eliminated directly in the faeces (50-90%) and partially absorbed with fatty foods. It is incorporated into chylomicrons reaching the blood where it binds some lipoprotein and thanks to its fat solubility it reaches different organs: liver, breast, colon, cervix, lens, iris and the retina where it is concentrated in the central region: the macula. Inside cells Lutein is placed through the lipid bilayer binding its polar groups with those of cell membranes. Lutein and zeaxanthin are present in the umbilical cord and pass through the placental barrier. They are also found in high concentrations in breast milk (higher than in plasma), particularly in colostrum; indicating an active secretion in milk. The rates of lutein in blood increases of 67% versus 14% for beta-carotene after the intake of foods rich in carotenoids. Coordinated and interdisciplinary studies, conducted both in vitro and in vivo, have shown that lutein plays a role in tissues defense th
Sponsor: University of Siena

Current Primary Outcome: Antioxidant status in the newborns [ Time Frame: First days of life ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Siena

Dates:
Date Received: February 17, 2014
Date Started: January 2011
Date Completion:
Last Updated: February 24, 2014
Last Verified: February 2014