Effects of Anthocyanin on Skin Health and Markers of Cardiovascular Disease Risk
Not Applicable
Completed
- Conditions
- Cardiovascular DiseaseSkin HealthPostmenopause
- Interventions
- Dietary Supplement: anthocyanin
- Registration Number
- NCT00574574
- Lead Sponsor
- University of East Anglia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 62
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 anthocyanin 500mg/d of anthocyanin, contained in 4 X 250mg capsules (125mg anthocyanin/ capsule). 2 capsules to be taken with food, twice per day (n=4 in total). 2 anthocyanin 500mg/d of placebo control containing no anthocyanin, 2 X 250mg capsules to be taken with food, twice per day (n=4, 250mg capsules in total / d).
- Primary Outcome Measures
Name Time Method Measure: Evidence of significant differences in skin health parameters, between active treatment and placebo supplementation period. 12 Weeks
- Secondary Outcome Measures
Name Time Method Measure: Evidence of significant differences in inflammatory status, between active treatment and placebo supplementation period. 12 Weeks
Trial Locations
- Locations (1)
University of East Anglia
🇬🇧Norwich, Norfolk, United Kingdom