Effects of Anthocyanin on Skin Health and Markers of Cardiovascular Disease Risk

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574574
• Other study ID #: R14764
• Secondary ID: BWF008
• Status: Completed
• Phase: N/A
• First received: December 14, 2007
• Last updated: July 10, 2009
• Start date: August 2007
• Est. completion date: February 2008

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Postmenopause
• Skin Health

Intervention

Dietary Supplement:
• anthocyanin
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).

Locations

Country	Name	City	State
United Kingdom	University of East Anglia	Norwich	Norfolk

Sponsors (4)

Lead Sponsor	Collaborator
University of East Anglia	Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK), Institute of Food Research, Unilever R&D

Country where clinical trial is conducted

United Kingdom, 

Outcome

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