Stradling 2018.

Methods	RCT of parallel‐group design (pilot)
Participants	Adults with stable HIV infection on anti‐retroviral treatment for > 6 months and LDL cholesterol > 3mmol/L from 3 UK centres in the West Midlands were recruited Exclusion criteria: planning pregnancy in next 6 months; current use of lipid‐lowering agents (any interfering drug or diet); secondary causes of dyslipidaemia (renal or liver disease, diabetes, hypothyroidism, familial hyperlipidaemia); known nut allergy; unstable psychiatric disorder (including eating disorders); current participation in a weight loss programme or other dietary intervention; and inability to understand printed materials
Interventions	60 patients were randomised to Diet 1: low saturated fat or Diet 2: Mediterranean Portfolio. Both groups attended 3 individual consultations with the research dietitian, and received further telephone reinforcement and support during the 6‐month intervention period. This was followed by a 6‐month maintenance period, with routine clinic visits only. The same research dietitian, experienced in HIV nutritional care, provided all consultations. Diet 1: low saturated fat Focus on reduction of saturated fat to < 10% of energy intake, in line with UK guidelines. Resources were provided, such as written information, recipes and online videos, covering various topics including sources of saturated fat, food swaps, food labelling, cooking methods, cheese facts and margarine types. On completion of the 12‐month outcome measurements, participants in group 1 received the dietary information from Diet 2 (Mediterranean Portfolio). Diet 2: Mediterranean Portfolio In addition to the information provided to group 1, participants allocated to Diet 2 received advice and support to adopt the Mediterranean diet supplemented by additional functional foods with cholesterol‐lowering properties. This was embedded within a motivational interviewing style consultation to include assessing readiness to change, utilising decisional balance, reflective listening and open‐ended questions, to identify needs, motivators and barriers to changing their diet. The diet was not prescriptive; goals were negotiated individually with each participant during their first session and reviewed at each visit. Daily consumption of 57 g tree nuts and 2 g plant stanols was encouraged in the form of 2 handfuls of unsalted mixed nuts (almonds, cashew nuts, peanuts, Brazil nuts, hazelnuts, pecans, walnuts, pistachios, macadamia nuts) and a 50 mL cholesterol‐lowering drink at randomisation and subsequent sessions. Participants were encouraged to continue with the nuts and stanols, while also aiming to eat 15 g/day soy protein as soya milk, yogurt or dessert, tofu and meat substitutes, and adopt a Mediterranean‐style diet, with more vegetables and fruit, olive oil and approximately 15 g to 20 g/day soluble fibre from oats, pearl barley, lentils, beans and flaxseed. Supplies of the functional foods (nuts, soy protein, plant stanols, oats and pulses) were given to participants to offset the additional cost of making dietary changes. Follow‐up 12 months
Outcomes	LDL cholesterol, SBP, DBP
Notes	12‐month follow‐up data kindly provided by the authors. ISRCTN32090191. Protocol paper published and conference abstracts with 6‐month follow‐up data.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A statistician produced a computer‐generated allocation sequence using random block sizes of 2 and 4, stratified by gender and smoking status
Allocation concealment (selection bias)	Low risk	The research dietitian allocated participants according to the diet number concealed in the next sequentially numbered, opaque, sealed envelope, relevant for their gender and smoking status
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	As this is a complex intervention, it was not possible to blind the participants, nor is it possible to blind the healthcare professionals. The terms Diet 1 and Diet 2 were used with the aim of achieving participant blinding to the exact content of the diet and type of foods included, to prevent Internet searching of diet titles and potential contamination between groups.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	At 12 months 6/31 and 5/29 missing data for some outcomes for Diet 1 and Diet 2 respectively. No further details at this stage as the full paper is not yet published.
Selective reporting (reporting bias)	Unclear risk	Results reported as conference proceedings only so cannot be determined
Other bias	Unclear risk	Insufficient information to judge