NCT00677599CompletedNot Applicable
Reducing Cardiovascular Risk With Dietary Flavonoids in Post Menopausal Women With Type 2 Diabetes
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of East Anglia
- Enrollment
- 152
- Locations
- 1
- Primary Endpoint
- 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 .
Study Overview
Brief 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). 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- — to 70 Years (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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
- •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
Arms & Interventions
Intervention B
Placebo Comparator
Intervention: Flavonoid enrichment (cocoa / soy compounds) (Dietary Supplement)
Intervention A
Active Comparator
Experimental arm enriched with flavonoids
Intervention: Flavonoid enrichment (cocoa / soy compounds) (Dietary Supplement)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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