None listed
Conditions
Brief summary
The primary purpose of the study is to test whether a supplement containing a specific component of cocoa (called flavanol) will decrease blood pressure, improve the function of the lining of blood vessels and increase sensitivity to insulin if consumed for 24 weeks.
Interventions
This is a randomised double-blind, controlled study conducted within a clinical setting with a parallel arm design. Participants randomised to the intervention group will receive a high flavanol content drink (494 mg) consumed twice a day (2 x 494 mg/day, i.e. total of 988 mg/day) for 24 weeks.
Sponsors
Baker IDI Heart and Diabetes Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Only patients who fulfil all of the following criteria will be eligible for inclusion in the study: type 2 diabetes for diabetes arm; Blood pressure (BP) as defined by the following (BP in Non-diabetic subjects: stable treated hypertension: 140 mm Hg less than or equal to SBP less than or equal to 179 mmHg and DBP less than or equal to 95 mm Hg, OR 90 mm Hgless than or equal to DBP less than or equal to 105mmHg and SBP less than or equal to 179 mm Hg. Diabetic subjects: stable treated hypertension: 130mm Hg less than or equal to SBP less than or equal to 179 mm Hg and DBP less than or equal to 95 mmHg, OR 80 mm Hgless than or equal to DBP less than or equal to 100 mm Hg and SBP less than or equal to 179 mm Hg.); For subjects with type 2 diabetes: 6.5% less than or equal to HbA1c less than or equal to 8.5%, and stable diabetes for 2 months preceding entry, and during the trial there will be no change in diabetes management unless fasting plasma glucose (FPG) > 12mM or hypoglycaemic events occur, and already on angiotensin converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) (for subjects with diabetes).
Exclusion criteria
Patients will be excluded from the study if any of the following apply1. Pregnancy2. Women of childbearing age who are contemplating pregnancy within the study period or who will not be using an adequate method of contraception3. Proliferative retinopathy4. Macro albuminuria5. Baseline urinary albumin: creatinine ratio less than assay detection limit6. Poorly controlled diabetes (HbA1c > 8.5%)7. On insulin8. Body mass index <18.0 or >40.09. Significant co-morbidity, including a history of cerebral infarction, cerebral haemorrhage or acute myocardial infarction10. On renal dialysis11. Life expectancy less than 6 months12. High baseline oral flavanol intake+Dietary entry exclusion criteria• vegetarians• habitual consumers of dietary of herbal supplements, including multivitamin supplements• habitual consumers of chocolate (daily consumption of any amount)• habitual consumers of cocoa drinks (daily consumption of any amount)• habitual consumers of > 2 cups of tea/day• habitual consumers of > 1 apple /day• habitual consumers of > glass of red wine per daySubjects will be asked to maintain a consistent flavanol intake for the duration of the study, and this will be assessed by food diaries.13. Current smokers, current tobacco users or current nicotine replacement users, defined as consumers of cigarettes, cigars, snuff, tobacco, nicotine replacement chewing gum or nicotine replacement transdermal patches within the preceding 90 days14. Habitual consumption of alcohol >2 standard (10g) drinks/day in men and women15. Allergies to cocoa or chocolate16. Allergies to nuts, especially peanuts17. Allergies to methylxanthines, i.e. caffeine and theobromineDiscontinuation of subjects from treatmentWithdrawal of subjects from this study may occur because of:• Withdrawal of informed consent• Development of exclusion criteria• Incorrect enrolment• Occurrence of an adverse event severe enough to warrant withdrawal• Deterioration in subject’s condition severe enough to warrant withdrawal.
Outcome results
None listed