Clinical trial NCT01480700: Consumption of Eggs Rich in Lutein and Omega-3 Fatty Acids on the Macular Pigment
Official title: Effect of Consumption of Eggs Rich in Xanthophyll Carotenoids and Omega-3 Fatty Acids on the Macular Pigment in Healthy People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Macular Degeneration
Keywords: eggs
Optical Macular Pigment
Age Macular Degeneration
study for the Age Macular Degeneration prevention
Lead sponsor: Institut Pasteur de Lille
Sponsor class: OTHER
Collaborators: name: Roquette Freres
name: Sanders
First posted: 2011-11-29
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is to determine the impact of the consumption of eggs rich in lutein/zeaxanthin from lucerne protein concentrate and DHA from microalgae on the plasma levels of these compounds but also on the macular pigment optical density, whose elevation may be beneficial in the prevention of Age-related Macular Degeneration (AMD).


Eligibility criteria: Inclusion Criteria:

* healthy subjects (male or female),
* 18 to 55 years
* Having signed the consent form,
* Susceptible to accept the stresses generated by the study,
* Insured.

Exclusion Criteria:

* Corrected Visual Acuity \<8/10th,
* History of cardiovascular disease, specifically coronary heart disease,
* Characterized dyslipidemia

  \* Total cholesterol ³ 2.50 g / L, and / or triglycerides ³ 2.00 g / L
* Lipid-lowering treatment,
* Current smoking or person who stopped smoking less than 6 months
* Cataract or cataract surgery,
* Diabetes
* Body Mass Index (BMI)\> 30 kg/m2,
* Taking food supplements in the 3 months preceding the start of the study (carotenoids, omega-3 fatty acids, phytosterols),
* Regular consumption in the three months preceding the start of the study products with added phytosterols.
* Regular consumption of high fatty fish or shellfish rich in omega-3 (4x a week or more): salmon, sardines, mackerel, herring, trout, tuna, red mullet, sea bass, bream, farmed turbot, mussels, squid / squid, anchovies.
* Allergy to eggs
* Dieting
* Difference significant weight over the last 3 months (\> 3 kg)
* Inability to understand or adhere to the protocol
* Persons deprived of liberty
* People in a position to judicial protection
* Pregnant Women.

Primary outcomes:
measure: change from baseline in optical density of macular pigment after 4 months of eggs consumption
timeFrame: before the eggs consumption and four months afterwards
Secondary outcomes:
measure: change from baseline in lutein and zeaxanthin in plasma and lipoproteins after 4 months of egg consumption
timeFrame: before the eggs consumption and four months afterwards
measure: change from baseline in fatty acids in plasma and lipoproteins after 4 months of egg consumption
timeFrame: before the eggs consumption and four months afterwards
Other outcomes:
Locations:
city: Lille
country: France
facility: Institut Pasteur de Lille
Study officials:
affiliation: Institut Pasteur de Lille
name: Jean-Michel Lecerf, MD
role: PRINCIPAL_INVESTIGATOR
References: