Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Skin Health Postmenopause Dietary Supplement: anthocyanin Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Biological Effects of an Anthocyanin Rich Dietary Supplement on Skin Ageing and Markers of Inflammation in Post-Menopausal Women
Study Start Date : August 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Arm Intervention/treatment
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).
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).

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).
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).




Primary Outcome Measures :
  1. Measure: Evidence of significant differences in skin health parameters, between active treatment and placebo supplementation period. [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Measure: Evidence of significant differences in inflammatory status, between active treatment and placebo supplementation period. [ Time Frame: 12 Weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574574


Locations
Layout table for location information
United Kingdom
University of East Anglia
Norwich, Norfolk, United Kingdom, NR4 7TJ
Sponsors and Collaborators
University of East Anglia
Quadram Institute Bioscience
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Unilever R&D
Investigators
Layout table for investigator information
Principal Investigator: Aedin MM Cassidy, PhD UEA
Layout table for additonal information
Responsible Party: Prof Aedin Cassidy, University of East Anglia
ClinicalTrials.gov Identifier: NCT00574574    
Other Study ID Numbers: R14764
BWF008
First Posted: December 17, 2007    Key Record Dates
Last Update Posted: July 14, 2009
Last Verified: July 2009
Keywords provided by University of East Anglia:
cardiovascular disease
CVD
skin health
postmenopausal women
anthocyanin
inflammation
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases