Clinical trial NCT00574574: Effects of Anthocyanin on Skin Health and Markers of Cardiovascular Disease Risk
Official title: Biological Effects of an Anthocyanin Rich Dietary Supplement on Skin Ageing and Markers of Inflammation in Post-Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Skin Health
Postmenopause
Keywords: cardiovascular disease
CVD
skin health
postmenopausal women
anthocyanin
inflammation
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: Quadram Institute Bioscience
name: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
name: Unilever R&D
First posted: 2007-12-17
Enrollment: 62
Sex: FEMALE
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Measure: Evidence of significant differences in skin health parameters, between active treatment and placebo supplementation period.
timeFrame: 12 Weeks
Secondary outcomes:
measure: Measure: Evidence of significant differences in inflammatory status, between active treatment and placebo supplementation period.
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: University of East Anglia
state: Norfolk
Study officials:
affiliation: UEA
name: Aedin MM Cassidy, PhD
role: PRINCIPAL_INVESTIGATOR
References: