Consumption of Eggs Rich in Lutein and Omega-3 Fatty Acids on the Macular Pigment (ALGOVUE)

Effect of Consumption of Eggs Rich in Xanthophyll Carotenoids and Omega-3 Fatty Acids on the Macular Pigment in Healthy People

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).

Study Overview

• Status: Completed
• Conditions: Age-related Macular Degeneration
• Intervention / Treatment: Other: Nutritional study

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59000
    • Institut Pasteur de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rich-eggs; subjects consume 2 eggs rich in lutein/zeaxanthin and DHA per day during 4 months	Other: Nutritional study; subjects consume 2 eggs per day during 4 months
Active Comparator: standard eggs; subjects consume 2 standard eggs per day	Other: Nutritional study; subjects consume 2 eggs per day during 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in optical density of macular pigment after 4 months of eggs consumption	optical density of macular pigment was measured with a Heidelberg Retinal Angiograph (HRA)specially modify for the measure of the pigment.	before the eggs consumption and four months afterwards

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in lutein and zeaxanthin in plasma and lipoproteins after 4 months of egg consumption	lutein and zeaxanthin were measured by HPLC	before the eggs consumption and four months afterwards
change from baseline in fatty acids in plasma and lipoproteins after 4 months of egg consumption	Fatty acids were measured by Gas Chromatography.	before the eggs consumption and four months afterwards

Collaborators and Investigators

• Sponsor: Institut Pasteur de Lille
• Collaborators: Roquette Freres; Sanders
• Investigators: Principal Investigator: Jean-Michel LECERF, MD, Institut Pasteur de Lille

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: September 13, 2011
• First Submitted That Met QC Criteria: November 28, 2011
• First Posted (Estimate): November 29, 2011

Study Record Updates

• Last Update Posted (Estimate): August 5, 2013
• Last Update Submitted That Met QC Criteria: August 2, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: eggs; Optical Macular Pigment; Age Macular Degeneration; study for the Age Macular Degeneration prevention
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: 2011-A00364-37