NCT00677599

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

May 13, 2011

Status Verified

May 1, 2011

Enrollment Period

1.9 years

First QC Date

May 12, 2008

Last Update Submit

May 12, 2011

Conditions

Cardiovascular DiseaseDiabetes

Keywords

Cardiovascular diseasetype 2 diabetesflavonoidscocoasoyepicatechinpostmenopausalcarotid intima media thicknessplaque volume

Outcome Measures

Primary Outcomes (1)

  • 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 .

    6 months - 1 year

Study Arms (2)

Intervention A

ACTIVE COMPARATOR

Experimental arm enriched with flavonoids

Dietary Supplement: Flavonoid enrichment (cocoa / soy compounds)

Intervention B

PLACEBO COMPARATOR
Dietary Supplement: Flavonoid enrichment (cocoa / soy compounds)

Interventions

Flavonoid enrichment (cocoa / soy compounds)DIETARY_SUPPLEMENT

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.

Also known as: Flavonoid enrichment of compounds found in cocoa and soy versus placebo control
Intervention A

Eligibility Criteria

AgeUp to 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of East Anglia (UK); School of Medicine, Health Policy and Practice

Norwich, Norfolk, NR47TJ, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 23553151DERIVED

  • Curtis 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.

    PMID: 22250063DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes MellitusDiabetes Mellitus, Type 2

Interventions

Chocolate

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Aedin MM Cassidy, PhD

    University of East Anglia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2008

First Posted

May 14, 2008

Study Start

May 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

May 13, 2011

Record last verified: 2011-05

Locations

GB(1)