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

Sponsor

Institut Pasteur de Lille (Other)

Overall Status

Completed

CT.gov ID

NCT01480700

Collaborator

Roquette Freres (Industry), Sanders (Other)

Enrollment

Location

Arms

16.1

Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Age-related Macular Degeneration	Other: Nutritional study	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Pasteur de Lille	Lille		France	59000

Sponsors and Collaborators

Institut Pasteur de Lille
Roquette Freres
Sanders

Investigators

Principal Investigator: Jean-Michel Lecerf, MD, Institut Pasteur de Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jean-Michel Lecerf, medical doctor specializing in endocrinology and metabolic diseases, Institut Pasteur de Lille

ClinicalTrials.gov Identifier:

NCT01480700

Other Study ID Numbers:

2011-A00364-37

First Posted:

Nov 29, 2011

Last Update Posted:

Aug 5, 2013

Last Verified:

Aug 1, 2013

Keywords provided by Jean-Michel Lecerf, medical doctor specializing in endocrinology and metabolic diseases, Institut Pasteur de Lille

eggs

Optical Macular Pigment

Age Macular Degeneration

study for the Age Macular Degeneration prevention

Additional relevant MeSH terms:

Macular Degeneration

Study Results

No Results Posted as of Aug 5, 2013