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

Age-related Macular Degeneration Clinical Trial

— ALGOVUE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480700
• Other study ID #: 2011-A00364-37
• Status: Completed
• Phase: N/A
• First received: September 13, 2011
• Last updated: August 2, 2013
• Start date: October 2011
• Est. completion date: February 2013

Study information

• Verified date: August 2013
• Source: Institut Pasteur de Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

Other:
• Nutritional study
subjects consume 2 eggs per day during 4 months

Locations

Country	Name	City	State
France	Institut Pasteur de Lille	Lille

Sponsors (3)

Lead Sponsor	Collaborator
Institut Pasteur de Lille	Roquette Freres, Sanders

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes