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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


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
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