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

NCT ID: NCT01480700

Last Updated: 2013-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-02-28

Brief Summary

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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).

Detailed Description

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Conditions

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Age-related Macular Degeneration

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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rich-eggs

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

Group Type EXPERIMENTAL

Nutritional study

Intervention Type OTHER

subjects consume 2 eggs per day during 4 months

standard eggs

subjects consume 2 standard eggs per day

Group Type ACTIVE_COMPARATOR

Nutritional study

Intervention Type OTHER

subjects consume 2 eggs per day during 4 months

Interventions

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Nutritional study

subjects consume 2 eggs per day during 4 months

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Roquette Freres

INDUSTRY

Sponsor Role collaborator

Sanders

UNKNOWN

Sponsor Role collaborator

Institut Pasteur de Lille

OTHER

Sponsor Role lead

Responsible Party

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Jean-Michel Lecerf

medical doctor specializing in endocrinology and metabolic diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Michel Lecerf, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur de Lille

Locations

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Institut Pasteur de Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2011-A00364-37

Identifier Type: -

Identifier Source: org_study_id