NCT02481466 due 2020.

Study name	Combined Portfolio diet and Exercise study (PortfolioEx)
Methods	RCT, 2 x 2 factorial design with exercise intervention, 36 months
Participants	Men and postmenopausal women with BMI up to 40 kg/m2 with measurable arterial thickening
Interventions	Lower saturated fat: advice on a therapeutic diet appropriate for hypercholesterolemia (ie < 7% of energy from saturated fat, < 200 mg/d cholesterol) PLUS the combination of viscous fibres, soy protein, plant sterols and nuts, 5% extra monounsaturated fat, and selection of low glycemic index foods Higher saturated fat: advice to follow a DASH‐like diet of whole grains, and low‐fat dairy products with fruits and vegetables Both arms with or without instruction on the Laval exercise program — a standardised physical activity/exercise component supervised by trained kinesiologists (exercise physiologists)
Outcomes	Primary: maximum vessel wall volume of the carotid arteries Secondary: composite end point of myocardial infarction, revascularization, cardiovascular hospitalisation, cardiovascular mortality and stroke; atrial fibrillation; BP; and vessel outcomes
Starting date	Nov 2016, planned completion Dec 2022
Contact information	PI: David J Jenkins, MD, NutritionProject@smh.ca, Risk Factor Modification Centre, St. Michael's Hospital
Notes	Trials registration: NCT02481466 Unclear whether the intervention was truly lower vs higher saturated fat as saturated fat goals not provided for both arms