'Best Foods For your heart' : a randomised controlled pilot study to assess the feasibility of a Mediterranean Portfolio dietary intervention for cardiovascular risk reduction in HIV dyslipidaemia

Portfolio foods (plant stanols, oats, soya, nuts) reduce levels of LDL-cholesterol; the Mediterranean diet reduces risk of cardiovascular disease. The dietary effects are unknown in HIV with the additional burdens of infection, inflammation and antiretroviral treatment (ART). This thesis examines the feasibility and efficacy of the combined Mediterranean-Portfolio diet to reduce cardiovascular risk in people with HIV dyslipidaemia.

Using a pilot, parallel, randomised controlled trial (ISRCTN32090191) recruiting 60 HIV-infected adults on ART with LDL-cholesterol >3mmol/l, we observed that advice to follow the Mediterranean-Portfolio diet produced a greater improvement in diet quality, blood pressure, and a significantly greater 10% reduction in LDL-cholesterol at month-6 than standard guidelines to reduce saturated fat intake. Analysis assuming full compliance and preserving randomisation suggests a possible doubling of this estimated treatment effect. Meta-analysis suggests this LDL-cholesterol reduction could reduce major vascular events by 12%.

Process evaluation explored fidelity, dose, uptake and reach, revealing:
· minor adaptations to intervention to accommodate individual needs,
· highly variable adherence (mean 59±21%), influenced by socio-economic status and confidence level rather than contextual factors,
· study food intake significantly increased in Mediterranean-Portfolio group,
· positive response to intervention, not intrusive to daily living, with indications of long-term behaviour change.