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

NCT00574574 | Completed

• 2 other identifiers: R14764BWF008
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Skin Health; Postmenopause

Keywords

cardiovascular disease; CVD; skin health; postmenopausal women; anthocyanin; inflammation

Outcome Measures

Primary Outcomes (1)

• Measure: Evidence of significant differences in skin health parameters, between active treatment and placebo supplementation period.

  12 Weeks

Secondary Outcomes (1)

• Measure: Evidence of significant differences in inflammatory status, between active treatment and placebo supplementation period.

  12 Weeks

Study Arms (2)

1

EXPERIMENTAL

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

2

PLACEBO COMPARATOR

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

Interventions

anthocyanin DIETARY_SUPPLEMENT

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).

1; 2

Eligibility Criteria

• Age: Up to 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of East Anglia: lead
• Quadram Institute Bioscience: collaborator
• Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK): collaborator
• Unilever R&D: collaborator

Study Sites (1)

University of East Anglia

Norwich, Norfolk, NR4 7TJ, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Inflammation

Interventions

Anthocyanins

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosides; Carbohydrates; Pigments, Biological; Biological Factors

Study Officials

• Aedin MM Cassidy, PhD

  UEA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 17, 2007
• Study Start: August 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: July 14, 2009

Record last verified: 2009-07

Locations

GB (1)