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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00574574
Other study ID # R14764
Secondary ID BWF008
Status Completed
Phase N/A
First received December 14, 2007
Last updated July 10, 2009
Start date August 2007
Est. completion date February 2008

Study information

Verified date July 2009
Source University of East Anglia
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether short-term exposure to a compound found in some fruits and vegetables (anthocyanin), is effective in improving skin health and reducing the levels of various markers of cardiovascular disease risk. A range of skin health parameters are being studied and volunteers are also providing skin biopsy, urine and blood samples. 62 postmenopausal women have been recruited for this study.


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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Dietary Supplement:
anthocyanin
500mg/d of anthocyanin each day for 12 weeks (84days). Route of administration: oral capsules, 4 X 250mg capsules (125mg anthocyanin/ capsule). Dosage advice; 2 capsules to be taken with food, twice per day (n=4 in total).

Locations

Country Name City State
United Kingdom University of East Anglia Norwich Norfolk

Sponsors (4)

Lead Sponsor Collaborator
University of East Anglia Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK), Institute of Food Research, Unilever R&D

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measure: Evidence of significant differences in skin health parameters, between active treatment and placebo supplementation period. 12 Weeks No
Secondary Measure: Evidence of significant differences in inflammatory status, between active treatment and placebo supplementation period. 12 Weeks No
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