Cardiovascular Disease, Postmenopause, Skin Health
Conditions
Keywords
cardiovascular disease, CVD, skin health, postmenopausal women, anthocyanin, inflammation
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.
Interventions
DIETARY_SUPPLEMENTanthocyanin
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).
Sponsors
Quadram Institute Bioscience
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Unilever R&D
University of East Anglia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure: Evidence of significant differences in skin health parameters, between active treatment and placebo supplementation period. | 12 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Measure: Evidence of significant differences in inflammatory status, between active treatment and placebo supplementation period. | 12 Weeks |
Countries
United Kingdom
Outcome results
None listed