Transplant Trial Watch

Modifying dietary patterns in cardiothoracic transplant patients to reduce cardiovascular risk: the AMEND-IT Trial.

Entwistle, T. R., et al.

Clinical Transplantation 2020 [record in progress]: e14186.


Aims
This study aimed to evaluate the feasibility and effectiveness of modifying dietary patterns to reduce cardiovascular risk in cardiothoracic transplant patients.

Interventions
Participants were randomised to either the Mediterranean diet group or the low-fat diet group.

Participants
21 lung and 20 heart transplant recipients.

Outcomes
The primary endpoint was the assessment of the feasibility of the Mediterranean dietary intervention versus the low-fat diet intervention. The secondary endpoints were the measurement of blood pressure, body mass index (BMI), body weight, glucose regulation markers, blood lipids and prednisolone dosage.

Follow-up
12 months

CET Conclusions
This is an interesting and good quality pilot study in cardiothoracic transplant recipients. Patients were randomised to a low-fat diet based on British Heart Foundation guidelines, or a “Mediterranean” diet supplemented with extra-virgin olive oil for 12 months. Both groups received a 5-hour education session, as well as attended cooking lessons with a trained chef. Those on the “Mediterranean” diet were asked to consume 40ml of olive oil per day (supplied by the study investigators). Physical activity was neither encouraged nor monitored. The report declares that 95% completed the study with good adherence to randomised diets, and this was assessed with a dietary questionnaire. After 12 months patients on the “Mediterranean” diet experienced a greater reduction in weight and in BMI but these are not statistically evaluated. The low fat group experienced a greater reduction in both diastolic and systolic blood pressure; again these are not compared with any statistical test of significance. Both groups had improved insulin resistance, total cholesterol and triglycerides. This is a pilot study for the moderation of dietary patterns in cardiothoracic transplant patients and it shows that these dietary changes are feasible and can be maintained for 12 months. A definitive study is required.

Jadad score
3

Data analysis
Available case analysis

Allocation concealment
No

Trial registration
ISRCTN63500150

Funding source
Non-industry funded