Cardiovascular DiseaseNCT00574574
Effects of Anthocyanin on Skin Health and Markers of Cardiovascular Disease Risk
A study testing anthocyanin in people with Cardiovascular Disease and Skin Health, run by University of East Anglia at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages Up to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Skin Health, Postmenopause
- What is being tested?
- anthocyanin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2007to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of East Anglia
Norwich, Norfolk, NR4 7TJ
About this study
Official title: Biological Effects of an Anthocyanin Rich Dietary Supplement on Skin Ageing and Markers of Inflammation in Post-Menopausal Women
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
- Being tested
- anthocyanin
- Keywords
- cardiovascular disease, CVD, skin health, postmenopausal women, anthocyanin, inflammation
- Medical subject headings
- Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anthocyaninDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Dietary Supplement: anthocyanin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Evidence of significant differences in skin health parameters, between active treatment and placebo supplementation period.
Measured: 12 Weeks
Secondary outcomes (1)
Measure: Evidence of significant differences in inflammatory status, between active treatment and placebo supplementation period.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startAug 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- Quadram Institute Bioscience, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK), Unilever R&D
- Investigators
- Aedin MM Cassidy, PhD, Principal investigator, UEA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574574
- Sponsor's protocol ID
- R14764
- Other IDs
- BWF008
- Status last verified
- Jul 2009
- First submitted
- 14 Dec 2007
- Last updated
- 14 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Effects of an Anthocyanin Rich Dietary Supplement on Skin Ageing and Markers of Inflammation in Post-Menopausal Women
- ClinicalTrials.gov ID
- NCT00574574
- Acronym / sponsor ID
- R14764
- Conditions
- Cardiovascular Disease, Skin Health, Postmenopause
- Keywords
- cardiovascular disease, CVD, skin health, postmenopausal women, anthocyanin, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- Quadram Institute Bioscience, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK), Unilever R&D
- Study start
- Aug 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 17 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: anthocyanin500mg/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). |
| 2 | Placebo comparator | Dietary Supplement: anthocyanin500mg/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). |
Who may qualify
- Ages
- Up to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anthocyanin500mg/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). | Dietary supplement | 1, 2 |
Primary outcome
Measure: Evidence of significant differences in skin health parameters, between active treatment and placebo supplementation period.
Time frame: 12 Weeks
1 secondary outcome
Measure: Evidence of significant differences in inflammatory status, between active treatment and placebo supplementation period.
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2009.
Related trials for Cardiovascular Disease
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aedin MM Cassidy, PhD principal investigator
UEA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anthocyanin in people with Cardiovascular Disease and Skin Health, run by University of East Anglia at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure: Evidence of significant differences in skin health parameters, between active treatment and placebo supplementation period. (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2009.