NCT01778231

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

2.2 years

First QC Date

January 25, 2013

Last Update Submit

August 12, 2019

Conditions

Healthy

Keywords

FocusuptakeLuteinZeaxanthinindividuals

Outcome Measures

Primary Outcomes (1)

  • Macular Pigment Measurement

    Macular Pigment Measurement using Heterochromatic Flicker Photometry

    16 weeks

Secondary Outcomes (2)

  • Serum Lutein and Zeaxanthin

    16 weeks

  • Macular Pigment (reflectometry)

    16 weeks

Study Arms (2)

Vitamin Supplement

EXPERIMENTAL

1 capsule of Nutrof Total made by Laboratories Thea for 16 weeks

Dietary Supplement: Nutrof Total

Inert oil capsule

PLACEBO COMPARATOR

1 capsule daily for 16 weeks

Dietary Supplement: Placebo

Interventions

Nutrof TotalDIETARY_SUPPLEMENT

Antioxidant and trace element supplement

Vitamin Supplement
PlaceboDIETARY_SUPPLEMENT
Inert oil capsule

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Public Health

Belfast, Antrim, BT126BA, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Ruth Hogg

Study Record Dates

First Submitted

January 25, 2013

First Posted

January 29, 2013

Study Start

March 1, 2011

Primary Completion

May 1, 2013

Study Completion

December 1, 2013

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations

GB(1)