IMAGEN: Effect of a dietary supplement on abdominal aortic aneurysm (AAA) growth

IMAGEN is a multicentre, prospective, parallel group, randomised, double-blinded placebo-controlled trial to assess if 4g of a dietary supplement daily over 12 months will reduce AAA growth. Participants who consent will undergo a thorough screening assessment for safety and suitability. Assessments include; physical and clinical examination, blood test, CT and Ultrasound of the abdomen, quality of life questionnaire and diet assessment. If the participants meet all inclusion criteria and no exclusion criteria they will be randomised (randomly allocated) to either the dietary supplement or placebo group. The participant will be blinded to the supplement name and it will be referred to as "the supplement" from the moment of initial contact. The dietary supplement and a placebo equivalent powder will be separately packaged in 500mg dose capsules. The capsules will be dispensed by an independent and unblinded pharmacist. Participants will be instructed to have four 500mg capsules twice per day at 8am and 8pm. Participants will revisit the site centre at 6 and 12 months after starting the trial to monitor adverse events, compliance and perform assessments. Participants will be contacted by telephone at 1, 3 and 9 months to monitor compliance and adverse events. The team will consist of experienced investigators, vascular surgeons, coordinators and researchers at each site. A steering committee, data and safety committee and publications committee will be established to oversee various aspects of the study to ensure the aims of the study are met while upholding the protocol