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

• ClinicalTrials.gov Identifier: NCT00574574
• Recruitment Status: Completed
• First Posted: December 17, 2007
• Last Update Posted: July 14, 2009
• Sponsor: University of East Anglia
• Collaborators: Quadram Institute Bioscience; Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK); Unilever R&D
• Information provided by: University of East Anglia

Tracking Information

• First Submitted Date: December 14, 2007
• First Posted Date: December 17, 2007
• Last Update Posted Date: July 14, 2009
• Study Start Date: August 2007
• Actual Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 14, 2007): Measure: Evidence of significant differences in skin health parameters, between active treatment and placebo supplementation period. [ Time Frame: 12 Weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: December 14, 2007): Measure: Evidence of significant differences in inflammatory status, between active treatment and placebo supplementation period. [ Time Frame: 12 Weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Cardiovascular Disease
• Skin Health
• Postmenopause

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).

Study Arms

• Experimental: 1
  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).
  Intervention: Dietary Supplement: anthocyanin
• Placebo Comparator: 2
  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).
  Intervention: Dietary Supplement: anthocyanin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: December 14, 2007): 62
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 2008
• Actual Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: up to 70 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00574574
• Other Study ID Numbers: R14764; BWF008
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Prof Aedin Cassidy, University of East Anglia
• Original Responsible Party: Same as current
• Current Study Sponsor: University of East Anglia
• Original Study Sponsor: Same as current

Collaborators

• Quadram Institute Bioscience
• Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
• Unilever R&D

Investigators

• Principal Investigator: Aedin MM Cassidy, PhD; UEA

• PRS Account: University of East Anglia
• Verification Date: July 2009