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Investigation of the Genetic and Environmental Determinants of MP Including Response to Supplementation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Ruth Hogg, Queen's University, Belfast.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01778231
First Posted: January 29, 2013
Last Update Posted: January 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ruth Hogg, Queen's University, Belfast
  Purpose
This study aims to investigate genetic and environmental determinants of macular pigment (MP) and assess the effects of lutein and zeaxanthin-rich supplements on macular pigment levels.

Condition Intervention
Healthy Dietary Supplement: Nutrof Total Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Investigation of the Genetic and Environmental Determinants of MP Including Response to Supplementation

Further study details as provided by Ruth Hogg, Queen's University, Belfast:

Primary Outcome Measures:
  • Macular Pigment Measurement [ Time Frame: 16 weeks ]
    Macular Pigment Measurement using Heterochromatic Flicker Photometry


Secondary Outcome Measures:
  • Serum Lutein and Zeaxanthin [ Time Frame: 16 weeks ]
  • Macular Pigment (reflectometry) [ Time Frame: 16 weeks ]
    Macular Pigment level measured using reflectometry


Estimated Enrollment: 100
Study Start Date: March 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin Supplement
1 capsule of Nutrof Total made by Laboratories Thea for 16 weeks
Dietary Supplement: Nutrof Total
Antioxidant and trace element supplement
Placebo Comparator: Inert oil capsule
1 capsule daily for 16 weeks
Dietary Supplement: Placebo

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers,
  • male or female,
  • aged 18-50 years

Exclusion Criteria:

  • evidence of eye disease,
  • inability to give informed written consent,
  • any other health problem which would interfere with ability to adhere to the study protocol.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778231


Locations
United Kingdom
Centre for Public Health Recruiting
Belfast, Antrim, United Kingdom, BT126BA
Contact: Estelle Lowry, MSc    +44 (0)28 9063 2636    e.lowry05@qub.ac.uk   
Sub-Investigator: Estelle Lowry, MSc         
Principal Investigator: Ruth Hogg, PhD         
Sub-Investigator: Jayne Woodside, PhD         
Sponsors and Collaborators
Queen's University, Belfast
  More Information

Responsible Party: Ruth Hogg, Dr Ruth Hogg, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT01778231     History of Changes
Other Study ID Numbers: 11/05v1
First Submitted: January 25, 2013
First Posted: January 29, 2013
Last Update Posted: January 29, 2013
Last Verified: January 2013

Keywords provided by Ruth Hogg, Queen's University, Belfast:
Focus
uptake
Lutein
Zeaxanthin
individuals