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

Primary Purpose

Age-related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nutritional study
Sponsored by
Institut Pasteur de Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Age-related Macular Degeneration focused on measuring eggs, Optical Macular Pigment, Age Macular Degeneration, study for the Age Macular Degeneration prevention

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Institut Pasteur de Lille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

rich-eggs

standard eggs

Arm Description

subjects consume 2 eggs rich in lutein/zeaxanthin and DHA per day during 4 months

subjects consume 2 standard eggs per day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

change from baseline in lutein and zeaxanthin in plasma and lipoproteins after 4 months of egg consumption
lutein and zeaxanthin were measured by HPLC
change from baseline in fatty acids in plasma and lipoproteins after 4 months of egg consumption
Fatty acids were measured by Gas Chromatography.

Full Information

First Posted
September 13, 2011
Last Updated
August 2, 2013
Sponsor
Institut Pasteur de Lille
Collaborators
Roquette Freres, Sanders
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1. Study Identification

Unique Protocol Identification Number
NCT01480700
Brief Title
Consumption of Eggs Rich in Lutein and Omega-3 Fatty Acids on the Macular Pigment
Acronym
ALGOVUE
Official Title
Effect of Consumption of Eggs Rich in Xanthophyll Carotenoids and Omega-3 Fatty Acids on the Macular Pigment in Healthy People
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut Pasteur de Lille
Collaborators
Roquette Freres, Sanders

4. Oversight

Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration
Keywords
eggs, Optical Macular Pigment, Age Macular Degeneration, study for the Age Macular Degeneration prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rich-eggs
Arm Type
Experimental
Arm Description
subjects consume 2 eggs rich in lutein/zeaxanthin and DHA per day during 4 months
Arm Title
standard eggs
Arm Type
Active Comparator
Arm Description
subjects consume 2 standard eggs per day
Intervention Type
Other
Intervention Name(s)
Nutritional study
Intervention Description
subjects consume 2 eggs per day during 4 months
Primary Outcome Measure Information:
Title
change from baseline in optical density of macular pigment after 4 months of eggs consumption
Description
optical density of macular pigment was measured with a Heidelberg Retinal Angiograph (HRA)specially modify for the measure of the pigment.
Time Frame
before the eggs consumption and four months afterwards
Secondary Outcome Measure Information:
Title
change from baseline in lutein and zeaxanthin in plasma and lipoproteins after 4 months of egg consumption
Description
lutein and zeaxanthin were measured by HPLC
Time Frame
before the eggs consumption and four months afterwards
Title
change from baseline in fatty acids in plasma and lipoproteins after 4 months of egg consumption
Description
Fatty acids were measured by Gas Chromatography.
Time Frame
before the eggs consumption and four months afterwards

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel Lecerf, MD
Organizational Affiliation
Institut Pasteur de Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Pasteur de Lille
City
Lille
ZIP/Postal Code
59000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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