Heart and lung transplant Surgery
Conditions
Interventions
Heart and lung transplant recipients meeting the inclusion criteria will be randomly assigned to either a Mediterranean diet or Low-fat intervention group using a computer-generated allocation sequenc
each intervention lasting 12 months, with an additional adherence questionnaire conducted at 6-weeks to determine short-term post-study adherence.
Both interventions will receive a ba
abundant use of extra-virgin olive oil (5ltrs of high quality extra-virgin olive oil will be gifted to each participant)
moderate consumption of dairy products and red wine
low intake of red and processed meats, sweets, sweet-baked pastries, desserts and sweetened bever
Sponsors
NHS Research and Development Centre, Wythenshawe Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female, aged 16 or over 2. Clinically stable, with a minimum post-transplant period of 6-months 3. Free from current rejection or infection, cancer or diabetes 4. Estimated glomerular filtration rate (eGFR) greater than 30 was the cut off. However, an eGFR >45 was the ideal lower limit 5. Not following any medically prescribed diet 6. No food allergies contra to study guidelines 7. Willing to make new dietary changes
Exclusion criteria
Exclusion criteria: 1. <16 years of age 2. <6-months post-surgery 3. Rejection and Infection 4. Cancer and diabetes 5. eGFR <30 6. Food allergy 7. Unwilling to make dietary changes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the feasibility and compliance of implementing a Mediterranean and low-fat dietary training programme in a group of clinically stable heart and lung transplant recipients using: 1. Recruitment and attrition rates of study participants will be recorded over the 12 month intervention 2. Measure changes in dietary pattern with a validated food frequency questionnaire at week 0 and 52 3. Monitor adherence to each diet with intervention-specific adherence screening questionnaires at week 0, 25, 52 and 58 4. Urinary polyphenol excretion at week 0, 25 and 52, detected with Folin-Ciocalteu total polyphenol test | — |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometric and biochemical changes at baseline and week 25 and 52 using: 1. Weight measured in kilograms using calibrated Seca 877® mobile weighing scales 2. Waist circumference measured in millimeters at iliac crest and underside of 12th 3. BMI calculated as weight and height (kg/m2) ratio 4. Basal metabolic rate calculated with metric Harris-Benedict formula 5. Blood pressure and heart rate taken seated with calibrated Dinamap Pro100V2® device 6. Fasting insulin and glucose detected on Abbott Architect c16000 Immunoassay Analyser 7. Fasting HbA1c detected on Bio-Rad Variant™ II Turbo haemoglobin testing system 8. HOMA2 insulin resistance, sensitivity and beta-cell function calculated with University of Oxford HOMA2 calculator 9. IGF-1 (baseline and 12 months only) measured on Immunodiagnostics Systems IDS-iSYS™ automated system 10. Fasting total cholesterol, HDL, LDL and triglycerides measured on Abbott Architect c16000 Immunoassay Analyser 11. Fasting lipid ratios; total cholesterol/HDL, LDL/HDL and triglyceride/HDL 12. HsCRP detected on Immunodiagnostics Systems IDS-iSYS™ automated system | — |
Countries
United Kingdom
Outcome results
None listed