Biological Effects of an Anthocyanin Rich Dietary Supplement on Skin Ageing and Markers of Inflammation in Post-Menopausal Women

University of East Anglia1 site in 1 country62 target enrollmentAugust 2007

ConditionsCardiovascular Disease Skin Health Postmenopause

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiovascular Disease
Sponsor: University of East Anglia
Enrollment: 62
Locations: 1
Primary Endpoint: Measure: Evidence of significant differences in skin health parameters, between active treatment and placebo supplementation period.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

February 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of East Anglia

Eligibility Criteria

Inclusion Criteria

•Upper age limit of 70 years
•Minimum of 1 year since last menstruation
•Not taking Hormone Replacement Therapy (HRT), and not having taken HRT for a minimum of 6 months prior to commencement
•Having no significant past or present medical history of: inflammatory conditions (including eczema, asthma, hay fever, IBS, crohn's disease and arthritis), diabetes, hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, thyroidal or psychiatric disease.
•Agreeing to restrict dietary intake of anthocyanin containing foodstuffs and also other foodstuffs considered to be cardio-protective i.e. red wine, total alcohol, oily fish, dark chocolate, tea and coffee.
•Agreeing to maintain existing cosmetic and beauty regime, and avoid 'tanning' (either naturally or synthetically) of the specific sites of skin function measurement during the study.
•BMI 20-32 kg/m2
•Successful biochemical, haematological and urinalysis assessment

Exclusion Criteria

•allergy / sensitivity to local anaesthetic i.e. Xylocaïne
•Regular use of aspirin, or other anti-inflammatory pain relief medication, as prescribed by a doctor. \[If subjects are regular self prescribed aspirin users and are willing to give up aspirin 2 months prior to the study and for the duration of the study they can be included.\]
•Taking other counter indicative medication e.g. steroidal medication during the trial, or within 1 month of the trial beginning.
•Taking food / dietary supplements e.g. vitamins, minerals, fish oils, plant oils, isoflavones, soy products, carotenoids during the trial (unless prepared to cease intake during, and 1 month preceding the trial).
•Those on therapeutic diets or following weight-loss diet.
•Current smoker, or smoker in the past year
•Having vaccinations or antibiotics within 3 months of start of trial, and those with vaccinations scheduled for during the trial
•Parallel participation in another research project which involves dietary intervention and/or sampling of biological fluids/material
•Participation in another research project within the last four months unless the total amount of combined blood from both studies will not exceed 470ml.
•Those intending to travel during the study to locations where a change in skin colour may be anticipated