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

This study has been completed.
Sponsor:
Collaborators:
Roquette Freres
Sanders
Information provided by (Responsible Party):
Jean-Michel Lecerf, Institut Pasteur de Lille
ClinicalTrials.gov Identifier:
NCT01480700
First received: September 13, 2011
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

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 Intervention
Age-related Macular Degeneration
Other: Nutritional study

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Institut Pasteur de Lille:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: before the eggs consumption and four months afterwards ] [ Designated as safety issue: Yes ]
    lutein and zeaxanthin were measured by HPLC

  • 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 ] [ Designated as safety issue: Yes ]
    Fatty acids were measured by Gas Chromatography.


Enrollment: 99
Study Start Date: October 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480700

Locations
France
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
  More Information

No publications provided

Responsible Party: Jean-Michel Lecerf, medical doctor specializing in endocrinology and metabolic diseases, Institut Pasteur de Lille
ClinicalTrials.gov Identifier: NCT01480700     History of Changes
Other Study ID Numbers: 2011-A00364-37
Study First Received: September 13, 2011
Last Updated: August 2, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Institut Pasteur de Lille:
eggs
Optical Macular Pigment
Age Macular Degeneration
study for the Age Macular Degeneration prevention

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014