ACTRN12614000891628.
| Methods |
Type of trial: efficacy trial Allocation: randomised Intervention model: cross‐over assignment Masking: double‐blinded (participants and study personnel) Primary purpose: treatment |
| Participants |
Condition: non‐insulin‐dependent type 2 diabetes mellitus Enrollment: 39 Inclusion criteria: adults with non‐insulin‐dependent type 2 diabetes mellitus; non‐smoking; women must be postmenopausal; dementia‐free; clinical systolic blood pressure between 130 and 160 mmHg; BMI < 40 kg/m²; computer literate; measurable ultrasound signal on both sides of the head; unlikely to change medication/supplements during the intervention Exclusion criteria: suspected dementia (3MS score < 78/100 determined at screening); smoker or currently on nicotine therapy; neurological conditions; kidney/liver disease; insulin therapy; major depression as diagnosed by a healthcare professional; visual problems including inability to distinguish the colours of red, green, blue, and yellow; illiterate; physical difficulty in both hands that will impede motor performance of the hand/arm; inability to obtain a measurable signal in the MCA; unwillingness to provide 2 blood samples at each visit; unwillingness to maintain pre‐enrolment physical activity levels and dietary habits for the duration of the study; unwillingness to fast for 4 hours; currently consuming resveratrol or other grape extract supplements |
| Interventions |
Intervention(s): resveratrol capsules (75, 150, or 300 mg once daily) Comparator(s): placebo capsules |
| Outcomes |
Primary outcome(s): use of transcranial doppler (TCD) ultrasound to determine the most efficacious dose of resveratrol to improve cerebral vasodilator responsiveness (CVR) to hypercapnia in the anterior circulation (MCA) in adults with T2DM Secondary outcome(s): clinic BP and arterial compliance (AC), CVR to hypercapnia measured with TCD ultrasound, CVR to neuropsychological tests measured with TCD ultrasound, blood sample collection and analysis, blood sample collection, analysis of plasma resveratrol concentration Other outcome(s): ‐ |
| Study details | Trial identifier:ACTRN12614000891628 |
| Publication details | Dose response evaluation of resveratrol supplementation on cerebrovascular function, mood, and cognitive performance in type 2 diabetes mellitus (T2DM) |
| Stated aim of study | Quote: "dose response evaluation of resveratrol supplementation on cerebrovascular function, mood, and cognitive performance in type 2 diabetes mellitus" |
| Notes | Two identified reports of this trial (Wong RH, et al. Low dose resveratrol improves cerebrovascular function in type 2 diabetes mellitus. Nutrition, Metabolism, and Cardiovascular Diseases 2016;26(5):393‐9; and Wong RH, et al. Acute resveratrol consumption improves neurovascular coupling capacity in adults with type 2 diabetes mellitus. Nutrients 2016;8(7)) do not report any of our review outcomes. The other outcomes of interest were planned to be investigated but have not yet been reported |