title: 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.
abstract: OBJECTIVE
  To assess the effect of dietary flavonoids on cardiovascular disease (CVD) risk in postmenopausal women with type 2 diabetes on established statin and hypoglycemic therapy.
  
  
  METHODS
  Despite being medicated, patients with type 2 diabetes have elevated CVD risk, particularly postmenopausal women. Although dietary flavonoids have been shown to reduce CVD risk factors in healthy participants, no long-term trials have examined the additional benefits of flavonoids to CVD risk in medicated postmenopausal women with type 2 diabetes. We conducted a parallel-design, placebo-controlled trial with type 2 diabetic patients randomized to consume 27 g/day (split dose) flavonoid-enriched chocolate (containing 850 mg flavan-3-ols [90 mg epicatechin] and 100 mg isoflavones [aglycone equivalents)]/day) or matched placebo for 1 year.
  
  
  RESULTS
  Ninety-three patients completed the trial, and adherence was high (flavonoid 91.3%; placebo 91.6%). Compared with the placebo group, the combined flavonoid intervention resulted in a significant reduction in estimated peripheral insulin resistance (homeostasis model assessment of insulin resistance [HOMA-IR] -0.3 ± 0.2; P = 0.004) and improvement in insulin sensitivity (quantitative insulin sensitivity index [QUICKI] 0.003 ± 0.00; P = 0.04) as a result of a significant decrease in insulin levels (-0.8 ± 0.5 mU/L; P = 0.02). Significant reductions in total cholesterol:HDL-cholesterol (HDL-C) ratio (-0.2 ± 0.1; P = 0.01) and LDL-cholesterol (LDL-C) (-0.1 ± 0.1 mmol/L; P = 0.04) were also observed. Estimated 10-year total coronary heart disease risk (derived from UK Prospective Diabetes Study algorithm) was attenuated after flavonoid intervention (flavonoid +0.1 ± 0.3 vs. placebo 1.1 ± 0.3; P = 0.02). No effect on blood pressure, HbA(1c), or glucose was observed.
  
  
  CONCLUSIONS
  One-year intervention with flavan-3-ols and isoflavones improved biomarkers of CVD risk, highlighting the additional benefit of flavonoids to standard drug therapy in managing CVD risk in postmenopausal type 2 diabetic patients.
authors.affiliation: Department of Nutrition, Norwich Medical School, University of East Anglia, Norwich, Norfolk, UK.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Curtis
authors.forename: Mike
authors.initials: M
authors.lastname: Sampson
authors.forename: John
authors.initials: J
authors.lastname: Potter
authors.forename: Ketan
authors.initials: K
authors.lastname: Dhatariya
authors.forename: Paul A
authors.initials: PA
authors.lastname: Kroon
authors.forename: Aedín
authors.initials: A
authors.lastname: Cassidy
mesh_terms: D000368:Aged; D002318:Cardiovascular Diseases / Q000097:blood / Q000517:prevention & control*; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D005419:Flavonoids / Q000627:therapeutic use*; D006801:Humans; D007333:Insulin Resistance / Q000502:physiology*; D007529:Isoflavones / Q000627:therapeutic use*; D008074:Lipoproteins / Q000097:blood*; D008875:Middle Aged; D017698:Postmenopause
chemical_list: D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D005419:Flavonoids; D007529:Isoflavones; D008074:Lipoproteins; C404987:flavan-3-ol; D002784:Cholesterol