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

NCT01480700 | Completed DMC

• 1 other identifier: 2011-A00364-37
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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).

Conditions

Age-related Macular Degeneration

Keywords

eggs; Optical Macular Pigment; Age Macular Degeneration; study for the Age Macular Degeneration prevention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

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

  before the eggs consumption and four months afterwards

Study Arms (2)

rich-eggs

EXPERIMENTAL

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

Other: Nutritional study

standard eggs

ACTIVE COMPARATOR

subjects consume 2 standard eggs per day

Other: Nutritional study

Interventions

Nutritional study OTHER

subjects consume 2 eggs per day during 4 months

rich-eggs; standard eggs

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy subjects (male or female),
• to 55 years
• Having signed the consent form,
• Susceptible to accept the stresses generated by the study,
• Insured.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institut Pasteur de Lille: lead
• Roquette Freres: collaborator
• Sanders: collaborator

Study Sites (1)

Institut Pasteur de Lille

Lille, 59000, France

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Jean-Michel Lecerf, MD

  Institut Pasteur de Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor specializing in endocrinology and metabolic diseases

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: November 29, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 5, 2013

Record last verified: 2013-08

Locations

FR (1)