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

This study is currently recruiting participants.
Verified January 2013 by Queen's University, Belfast
Sponsor:
Information provided by (Responsible Party):
Ruth Hogg, Queen's University, Belfast
ClinicalTrials.gov Identifier:
NCT01778231
First received: January 25, 2013
Last updated: January 28, 2013
Last verified: January 2013
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Investigation of the Genetic and Environmental Determinants of MP Including Response to Supplementation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Macular Pigment Measurement [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Macular Pigment Measurement using Heterochromatic Flicker Photometry


Secondary Outcome Measures:
  • Serum Lutein and Zeaxanthin [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Macular Pigment (reflectometry) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: Ruth Hogg, Dr Ruth Hogg, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT01778231     History of Changes
Other Study ID Numbers: 11/05v1
Study First Received: January 25, 2013
Last Updated: January 28, 2013
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on April 14, 2014