Cardiovascular Disease Clinical Trial
Official title:
Biological Effects of an Anthocyanin Rich Dietary Supplement on Skin Ageing and Markers of Inflammation in Post-Menopausal Women
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 |
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.
Status | Completed |
Enrollment | 62 |
Est. completion date | February 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A to 70 Years |
Eligibility |
Inclusion Criteria: - Female - 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 - Subjects intending to deliberately "sunbathe", use tanning solariums or tanning creams on body sites used for assessment. - Assessed from the clinical screening - abnormal renal function (Na >145mmol/L, K >5.0mmol/L, Urea >7.1mmol/L, Albumin >50g/L, Creatinine >125µmol/L, Total bilirubin >22µmol/L), or liver function (ALP >126 IU/L, ALT >50 IU/L), lipid profile (Total cholesterol > 6.5 mmol/l, TAG >3.0 mmol/l, HDL>2.0 mmol/l), anaemia (Haemoglobin <11.5g/dL), fasting glucose (> 6.1 mmol/l) or measurements considered to be counter indicative of the trial outcome measures. - Untreated hypertension (>160/90mmHg) or hypotension (90/50mmHg or 95/50mmHg if symptomatic) - BMI <19.5 or >32.5 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of East Anglia | Norwich | Norfolk |
Lead Sponsor | Collaborator |
---|---|
University of East Anglia | Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK), Institute of Food Research, Unilever R&D |
United Kingdom,
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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