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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2013 by Queen's University, Belfast.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Ruth Hogg, Queen's University, Belfast Identifier:
First received: January 25, 2013
Last updated: January 28, 2013
Last verified: January 2013

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
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

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


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01778231

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

No publications provided

Responsible Party: Ruth Hogg, Dr Ruth Hogg, Queen's University, Belfast 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:
individuals processed this record on October 08, 2015