Cardiovascular DiseaseFLAVONCT00677599
The FLAVO Trial: Dietary Flavonoids and Cardiovascular Disease Risk Reduction in Postmenopausal Women With Type 2 Diabetes
A study testing Flavonoid enrichment (cocoa / soy compounds) in people with Cardiovascular Disease and Diabetes, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
The purpose of this placebo controlled trial is to determine whether a year long intervention with flavonoids (found in cocoa and soy) is more effective in reducing the risk of cardiovascular disease in postmenopausal women with type 2 diabetes, than standard therapy (statins). Read more about this study
- Who is it for?
- Ages Up to 70 years, women only
- Conditions the study is for
- Cardiovascular Disease, Diabetes
- What is being tested?
- Flavonoid enrichment (cocoa / soy compounds)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2008to Apr 2010
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female
- Having had a natural menopause and a minimum of 1 year since last menstruation
- Caucasian
- under 70 years
- Type 2 diabetics
- Those using statins (≥40 mg simvastatin or ≥10 mg atorvastatin) for at least 12 months
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- Not currently 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 vascular disease, or cancers (specifically breast, uterine or ovarian)
- Never-smokers, and ex-smokers who have given up smoking at least 12 months before recruitment to the study
Who cannot join
- Currently taking HRT or having taken this medication within 6 months of the trial
- Those prescribed to use statin therapy for less than 12 months Significant past or present medical history of vascular disease (including ECG and enzyme confirmed myocardial infarction, clinical angina, ischaemic stroke peripheral vascular disease, intermittent claudication) or cancer (especially breast, uterine or ovarian)
- Hypertensive's with a systolic BP ≥ 160 mm Hg at maximum, or hypertensive's with a systolic BP ≤160 mm Hg at maximum, but who have received antihypertensive therapy for less than 12 months or have had increases to their medication indicating poor control
- Current smokers or those having given up smoking less than 12 months before recruitment to the study
- Those prescribed aspirin for a period of less than 12 months prior to recruitment
- Those prescribed insulin for a period of less than 12 months prior to recruitment and those having had increases to their medication indicating poor control
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- Regular non-prescribed use of anti-inflammatory pain relief medication (i.e. aspirin, paracetamol, cocodamol).
- 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).
- Having vaccinations (excluding the flu vaccination) 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
- Assessed from the clinical screening: HbA1c ≥ 10%; Creatinine >125µmol/L; ALP > 378 IU/L; ALT >150 IU/L; GGT > 180 IU/L
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of East Anglia (UK); School of Medicine, Health Policy and Practice
Norwich, Norfolk, NR47TJ
About this study
Official title: Reducing Cardiovascular Risk With Dietary Flavonoids in Post Menopausal Women With Type 2 Diabetes
The purpose of this placebo controlled trial is to determine whether a year long intervention with flavonoids (found in cocoa and soy) is more effective in reducing the risk of cardiovascular disease in postmenopausal women with type 2 diabetes, than standard therapy (statins). A range of markers of cardiovascular disease risk are being studied and volunteers are also providing urine and blood samples. 152 postmenopausal women, from the locality, will be recruited for this study.
- Conditions
- Cardiovascular Disease, Diabetes
- Being tested
- Flavonoid enrichment (cocoa / soy compounds)
- Keywords
- Cardiovascular disease, type 2 diabetes, flavonoids, cocoa, soy, epicatechin, postmenopausal, carotid intima media thickness, plaque volume
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavonoid enrichment (cocoa / soy compounds)Dietary supplement
Also called Flavonoid enrichment of compounds found in cocoa and soy versus placebo control
Flavonoid compounds from cocoa (including epicatechin) and soy to be consumed for 365days in the experimental intervention (versus placebo consumption). 27g chocolate bar the vehicle for flavonoid enrichment.
Flavonoid enrichment (cocoa / soy compounds)Dietary supplement
27g placebo chocolate bar to be consumed for 365 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention A | Active comparator | Experimental arm enriched with flavonoids Receives: Dietary Supplement: Flavonoid enrichment (cocoa / soy compounds) |
| Intervention B | Placebo comparator | Not described Receives: Dietary Supplement: Flavonoid enrichment (cocoa / soy compounds) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiovascular disease risk indictaors - including carotid intima-media thickness (CIMT), total plaque volume (TPV) (at the carotid bifurcation), pulse wave velocity (PWV) and biomarkers of risk in blood samples .
Measured: 6 months - 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startMay 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- Quadram Institute Bioscience, The Bertram Diabetes Centre & Radiology department (Norfolk & Norwich University Hospital, UK), Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK), Diabetes UK, Frutarom Netherlands B.V. - Soy producer, Barry Callebaut - chocolate manufacturer contracted to produce intervention foods
- Investigators
- Aedin MM Cassidy, PhD, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677599
- Sponsor's protocol ID
- R15098
- Other IDs
- REC Ref: 07/H0310/136
- Acronym
- FLAVO
- Status last verified
- May 2011
- First submitted
- 12 May 2008
- Last updated
- 13 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Curtis PJ, Potter J, Kroon PA, Wilson P, Dhatariya K, Sampson M, Cassidy A. Vascular function and atherosclerosis progression after 1 y of flavonoid intake in statin-treated postmenopausal women with type 2 diabetes: a double-blind randomized controlled trial. Am J Clin Nutr. 2013 May;97(5):936-42. doi: 10.3945/ajcn.112.043745. Epub 2013 Apr 3.
PubMed 23553151Curtis PJ, Sampson M, Potter J, Dhatariya K, Kroon PA, Cassidy A. Chronic ingestion of flavan-3-ols and isoflavones improves insulin sensitivity and lipoprotein status and attenuates estimated 10-year CVD risk in medicated postmenopausal women with type 2 diabetes: a 1-year, double-blind, randomized, controlled trial. Diabetes Care. 2012 Feb;35(2):226-32. doi: 10.2337/dc11-1443. Epub 2012 Jan 16.
PubMed 22250063
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Cardiovascular Risk With Dietary Flavonoids in Post Menopausal Women With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00677599
- Acronym / sponsor ID
- FLAVO / R15098
- Conditions
- Cardiovascular Disease, Diabetes
- Keywords
- Cardiovascular disease, type 2 diabetes, flavonoids, cocoa, soy, epicatechin, postmenopausal, carotid intima media thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- Quadram Institute Bioscience, The Bertram Diabetes Centre & Radiology department (Norfolk & Norwich University Hospital, UK), Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK), Diabetes UK, Frutarom Netherlands B.V. - Soy producer, Barry Callebaut - chocolate manufacturer contracted to produce intervention foods
- Study start
- May 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 14 May 2008 (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 placebo controlled trial is to determine whether a year long intervention with flavonoids (found in cocoa and soy) is more effective in reducing the risk of cardiovascular disease in postmenopausal women with type 2 diabetes, than standard therapy (statins). A range of markers of cardiovascular disease risk are being studied and volunteers are also providing urine and blood samples. 152 postmenopausal women, from the locality, will be recruited for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention A | Active comparator | Dietary Supplement: Flavonoid enrichment (cocoa / soy compounds)Experimental arm enriched with flavonoids |
| Intervention B | Placebo comparator | Dietary Supplement: Flavonoid enrichment (cocoa / soy compounds) |
Who may qualify
- Ages
- Up to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Female
- Having had a natural menopause and a minimum of 1 year since last menstruation
- Caucasian
- under 70 years
- Type 2 diabetics
Key exclusion criteria (12 listed)
- Currently taking HRT or having taken this medication within 6 months of the trial
- Those prescribed to use statin therapy for less than 12 months Significant past or present medical history of vascular disease (including ECG and enzyme confirmed myocardial infarction, clinical angina, ischaemic stroke peripheral vascular disease, intermittent claudication) or cancer (especially breast, uterine or ovarian)
- Hypertensive's with a systolic BP ≥ 160 mm Hg at maximum, or hypertensive's with a systolic BP ≤160 mm Hg at maximum, but who have received antihypertensive therapy for less than 12 months or have had increases to their medication indicating poor control
- Current smokers or those having given up smoking less than 12 months before recruitment to the study
- Those prescribed aspirin for a period of less than 12 months prior to recruitment
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 |
|---|---|---|
| Flavonoid enrichment (cocoa / soy compounds)Also: Flavonoid enrichment of compounds found in cocoa and soy versus placebo controlFlavonoid compounds from cocoa (including epicatechin) and soy to be consumed for 365days in the experimental intervention (versus placebo consumption). 27g chocolate bar the vehicle for flavonoid enrichment. | Dietary supplement | Intervention A |
| Flavonoid enrichment (cocoa / soy compounds)27g placebo chocolate bar to be consumed for 365 days. | Dietary supplement | Intervention B |
Primary outcome
Change in cardiovascular disease risk indictaors - including carotid intima-media thickness (CIMT), total plaque volume (TPV) (at the carotid bifurcation), pulse wave velocity (PWV) and biomarkers of risk in blood samples .
Time frame: 6 months - 1 year
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 13 May 2011.
- Derived from this study: PubMed 23553151Curtis PJ, Potter J, Kroon PA, Wilson P, Dhatariya K, Sampson M, Cassidy A. Vascular function and atherosclerosis progression after 1 y of flavonoid intake in statin-treated postmenopausal women with type 2 diabetes: a double-blind randomized controlled trial. Am J Clin Nutr. 2013 May;97(5):936-42. doi: 10.3945/ajcn.112.043745. Epub 2013 Apr 3.
- Derived from this study: PubMed 22250063Curtis PJ, Sampson M, Potter J, Dhatariya K, Kroon PA, Cassidy A. Chronic ingestion of flavan-3-ols and isoflavones improves insulin sensitivity and lipoprotein status and attenuates estimated 10-year CVD risk in medicated postmenopausal women with type 2 diabetes: a 1-year, double-blind, randomized, controlled trial. Diabetes Care. 2012 Feb;35(2):226-32. doi: 10.2337/dc11-1443. Epub 2012 Jan 16.
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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
University of East Anglia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavonoid enrichment (cocoa / soy compounds) in people with Cardiovascular Disease and Diabetes, 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 12 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 13 May 2011. 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?
Change in cardiovascular disease risk indictaors - including carotid intima-media thickness (CIMT), total plaque volume (TPV) (at the carotid bifurcation), pulse wave velocity (PWV) and biomarkers of risk in blood samples . (time frame: 6 months - 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00677599, which also lists 2 linked publications.
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 13 May 2011.