A randomised controlled trial to evaluate an intensive lifestyle program for reversal of coronary heart disease.

INTERVENTION: Intensive lifestyle program (ILP) + Optimal medical therapy (OMT). Participants in this group will receive OMT, which refers to continued communication and reviews from their cardiologist who will adjust medications as required over the course of the study. They will also receive IMT which involves 1 year of a 5:2 pesco‐vegetarian diet, physical activity and mindfulness training. Participants will be educated, instructed, and monitored through a phone‐app. Participants will have regular face‐to‐face or Zoom call contact with study a dietician, exercise physiologist, and a mindfulness coach who will monitor their progress through the app. Details of each aspect can be seen below: 5:2 PESCO‐VEGETARIAN DIET: Participants will be provided with food from Marley Spoon, who will deliver freshly made meals for the first 4 weeks of the intervention. They will also work alongside the study dietitian to design their weekly meal plans and menus in order to transition into making their own food after the first 4 weeks. The aim will be to substitute meat with fish and processed and refined foods with a range of minimally processed plant‐based foods. Individuals will be asked to fast on 2 non‐consecutive days of the week, allowing 2 vegetable meals of around 2000 kJ per day for women and about 2500 kJ for men. Participants will meet with the study dietician in person for an initial appointment at baseline. They will then be offered zoom or face‐to‐face meetings (30‐45mins) bi‐weekly for the first 3 months and monthly thereafter. Strategies to implement the dietary changes, meal planning, healthy recipes and nutritional information will be covered during dietician appointments. Body weight will be monitored weekly to help assess if participants are compliant with the diet CONDITION: Cardiovascular ‐ Coronary heart disease Coronary Heart Disease; ; Coronary Heart Disease PRIMARY OUTCOME: Change in Low‐attenuation plaque volume (mm3) at 12 months with respect to baseline level using CT angiography. [Baseline and at 12 months after randomisation.] Change in Myocardial blood flow (ml/g/min) at 12‐month with respect to baseline level using MRI. [Baseline and at 12 months after randomisation] SECONDARY OUTCOME: Fasting glucose (mmol/L) from blood sample.[Baseline then 1,6,12 months after randomisation. ] Aerobic capacity using the 6‐minute walk test (6‐MWT).[Baseline and 12 months after randomisation. INCLUSION CRITERIA: • Presence of LAP on coronary CTA • 18‐80 years of age • BMI greater than or equal to 22.0 kg/m2 • Able to give full informed consent • Able to undergo all study evaluations and adhere to the rigors of the ILP intervention ; ] Augmentation Index (AI) (%) using the SphygmoCor XCEL system.[Baseline then 1,6,12 months after randomisation. ] Blood pressure will be assessed using the SphygmoCor XCEL device.[Baseline then 1,6,12 months after randomisation. ] Body mass (kg) using digital scales. [Baseline then 1,6,12 months after randomisation. ] Bone mineral density (g/cm2) of the hip using DEXA.[Baseline and 12 months after randomisation.] Carotid intima‐media thickness (cIMT) (mm) using high‐resolution ultrasound.[Baseline then 1,6,12 months after randomisation. ] Composite metabolic control: Glucose and insulin response to oral glucose tolerance test (75g) at 0,30,60,120 minutes.[Baseline and 12 months after randomisation.] Composite outcome of blood lipids (triglycerides, LDL‐C, HDL‐C) quantified by venous sampling. .[Baseline then 1,6,12 months after randomisation. ] Fasting insulin (pmol/L) from blood sample.[Baseline then 1,6,12 months after randomisation. ] Flow‐mediated dilatation (FMD) (%) using high‐resolution ultrasound.[Baseline then 1,6,12 months after randomisation. ] HbA1c quantified by venous sampling. .[Baseline then 1,6,12 months after randomisation. ] Heart rate variability (HRV): Low Frequency (LF) and High Frequency (HF) (ms2) using the Human Non‐Invasive Blood Pressure System. [Baseline then 1,6,12 months after randomisation. ] Height (cm) using a wall‐mounted stadiometer[Baseline] Inflammation, assessed by composite outcome of of high‐sensitivity C‐reactive protein (hs‐CRP) and Tumour Necrosis Factor Alpha (TNF‐a) from venous blood.[Baseline then 1,6,12 months after randomisation. ] Liver fat density (%) using the MR proton density fat fraction (PDFF) technique.[Baseline and at 12 months after randomisation..] Pulse wave velocity (PWV) (m/s) using the SphygmoCor XCEL system[Baseline then 1,6,12 months after randomisation. ] Sleep efficiency (%) using the Nox‐T3+ device will be determined from total time spent asleep as a proportion of total time spent in bed.[Baseline and at 12 months after randomisation.] Sleep onset latency (SOL) using the Nox‐T3+ device by NoxMedical (Iceland), distributed by Temple Healthcare.[Baseline and 12 months after randomisation.] Total atheroma volume (TAV, mm3) using CT angiography.[Baseline and at 12 months after randomisation] Total sleep time (mins) using the Nox‐T3+ device by NoxMedical (Iceland), distributed by Temple Healthcare. Participants will wear the device overnight to assess sleep parameters.[Baseline and at 12 months after randomisation.] Urinary levels of F2‐isoprostane levels.[Baseline and 12 months after randomisation.] Wake after sleep onset (WASO) using the Nox‐T3+ device by NoxMedical (Iceland), distributed by Temple Healthcare.[Baseline and 12 months after randomisation.] Whole body fat mass (kg) measured by DEXA using our Hologic Discovery W Dual Energy X‐Ray Absorptiometry Scanner.[Baseline and 12 months after randomisation.] Whole body fat‐free mass measured by DEXA using our Hologic Discovery W Dual Energy X‐Ray Absorptiometry Scanner[Baseline and 12 months after randomisation.]