Assessment of the mediterranean diet in heart and lung transplantation

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2016
INTERVENTION: 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 sequence with random block sizes and an equal 1:1 allocation ratio. Randomised codes will be sent to a fellow researcher to blind the investigator from recruitment bias. Recruitment will commence in two separate arms spaced 6 months apart; 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 baseline education and training session designed to represent each diet. As a support strategy, each participant is encouraged to attend with a member of the same household. Training sessions will comprise of the background and scientific rationale for the respective interventions, and a practical food preparation and cooking component with a trained chef. Participants will receive group‐specific printed information, and each intervention will be offered the same foundational dietary advice based on plant‐based wholefoods. Mediterranean diet group: MedDiet participants will receive educational support to follow an eating pattern representative of a traditional Mediterranean diet. The key dietary guidelines advocated in the MedDiet group are: daily consumption of a range of mixed vegetables, fruit, whole‐grains, fish and seafood, raw nuts and legumes; 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 beverages. Low‐fat diet group: The low‐fat diet group will be advised to follow modified British Heart Foundation low‐fat guidelines. Key low‐fat diet information includes: minimise high fat foods such as processed meats, commercial baked pastries and CONDITION: Heart and lung transplant ; Surgery PRIMARY OUTCOME: 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 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 SECONDARY OUTCOME: 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;
Epistemonikos ID: c17e55b52e861aa2d3d8a9056b3c01d60bfaa037
First added on: Aug 24, 2024