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Completed

NCT Number: NCT01480700

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

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).

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Pasteur de Lille

Lille, 59000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional study

Other

subjects consume 2 eggs per day during 4 months

Primary outcomes

  1. change from baseline in optical density of macular pigment after 4 months of eggs consumption

    Time frame: 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 outcomes

  1. change from baseline in lutein and zeaxanthin in plasma and lipoproteins after 4 months of egg consumption

    Time frame: before the eggs consumption and four months afterwards

    lutein and zeaxanthin were measured by HPLC

  2. change from baseline in fatty acids in plasma and lipoproteins after 4 months of egg consumption

    Time frame: before the eggs consumption and four months afterwards

    Fatty acids were measured by Gas Chromatography.

Sponsors and collaborators

Lead sponsor

Institut Pasteur de Lille

Other

Collaborators

  • Roquette Freres
  • Sanders

Registry information

Official study title

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

Acronym: ALGOVUE

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 29, 2011
Registry last updated
Aug 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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