Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00574574
Recruitment Status : Completed
First Posted : December 17, 2007
Last Update Posted : July 14, 2009
Sponsor:
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  ICMJE December 14, 2007
First Posted Date  ICMJE December 17, 2007
Last Update Posted Date July 14, 2009
Study Start Date  ICMJE August 2007
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT00574574 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Anthocyanin on Skin Health and Markers of Cardiovascular Disease Risk
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Disease
  • Skin Health
  • Postmenopause
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 14, 2007)
62
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00574574
Other Study ID Numbers  ICMJE R14764
BWF008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof Aedin Cassidy, University of East Anglia
Study Sponsor  ICMJE University of East Anglia
Collaborators  ICMJE
  • Quadram Institute Bioscience
  • Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
  • Unilever R&D
Investigators  ICMJE
Principal Investigator: Aedin MM Cassidy, PhD UEA
PRS Account University of East Anglia
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP