We will flush the deceased donor kidney with UW (perfusion solution) + sodium thiosulfate (STS)

Kidney will be flushed with UW (perfusion solution) which is the normal standard of care.

End Stage Renal Disease (ESRD)

The kidney will have 100 mL of 500µM STS added directly to the existing pulsatile perfusion solution at 4°C.

Seacalphyx (sodium thiosulfate pentahydrate injection BP) 25%

London Health Sciences Centre, University Hospital

Evaluation of Thiosulfate in End Stage Renal Disease and Kidney Transplantation

between 1 week and 1 year following transplant

Measuring death of tubular epithelial cells that form the renal tubules of the kidneys.

Patient Urine protein/creatinine ratio results

Patient urinary injury biomarkers (KIM-1/NGAL).

Alp Sener

Principal Investigator

Lawson Health Research Institute

For the purposes of this study we will flush the deceased donor kidney with UW (perfusion solution) or UW + sodium thiosulfate (STS). There will be two groups in the study - UW with or without STS and patients will be randomly assigned to a group in a 1:1 ratio (i.e. 50 in one group and 50 in the other).

Participants will be given written educational material to encourage dietary change towards a better quality diet. Educational material will be adapted from resources used in previous dietary intervention studies.

Participants will also be given the educational material, but will be encouraged to make dietary change using individualized recommendations incorporating food markers of specific components of a high quality diet. Food markers of diet quality will be used to develop an algorithm to deliver personalized dietary advice. Based on biomarker data, a system of categorization of biomarker status will be developed, alongside dietary advice related to this biomarker categorization, and decision trees created, as previously described in the Food4Me study, to ensure standardized delivery of advice within this intervention arm.

Cardiovascular Diseases

Personalised dietary advice and educational material

Educational material

The Efficacy of Individualized Dietary Advice in Improving Diet Quality and Cardiovascular Health

Dietary intake will be assessed using an online version of the Prime Diet Quality Score (PDQS). Foods are classified as healthy and unhealthy. Points will be assigned according to the following criteria: 0-1 serving/wk (0 point) compared with 2-3 servings/wk (1 point) compared with ≥4 servings/wk (2 points) for the healthy food groups. Scoring will be reversed and points deducted for the unhealthy food groups. Points for each food group will be then summed to give an overall score. The PDQS has 21 food groups and ranges from 0 to 42 total points.

Questionnaire to assess number of units consumed weekly

Questionnaire to assess usual medication use (drug name, dose and frequency of use)

Physical activity using an accelerometer; data to be used will be total step count

Weight will be measured in kg using calibrated scales.

Waist and hip circumference will be measured in cm according to standardised operating procedures using a tape measure.

Height will be measured in metres using a stadiometer.

Body composition (% body fat) will be measured using bioelectrical impedence (Bodystat 1500).

Blood pressure will be measured twice from the right arm, using an automated Omron sphygmomanometer, with the participant sitting quietly for at least five minutes.

Serum lipids (total cholesterol, HDL-C, and TG) and whole blood HbA1c will be assessed by enzymatic assays (Randox Ltd, Crumlin, NI and Glen Bio, Antrim, NI) on an I-Lab 600 auto-analyzer. LDL-C will be calculated.

The following biomarkers will be used to assess nutritional status response to the dietary intervention: red meat - methylhistidines and carnosine; white meat - TMAO, guanidoacetate, anserine; fruit and vegetables -- proline betaine, isothiocyanates, S-methyl-L-cysteine sulfoxide, and tartaric acid; wholegrains - alkylresorcinols; coffee - phenolic acids, N-methylpyridinium, trigonelline, 2-furoylglycine; SSBs -- formate, citrulline, taurine, and isocitrate) red meat- methylhistidines; oily fish- omega-3 index; fruit and vegetables- total carotenoids and proline betaine; wholegrain- alkylresorcinols.

Sample handling and nucleic acid purifications will be performed following an established protocol. Illumina DNA-seq libraries with fragment length of ~300 bp will be generated as previously described, with Pippen prep size selection. For RNA-seq, 5ug of RNA will be enriched for mRNA and subjected to strand-specific cDNA synthesis using established protocols. Paired-end sequencing (e.g. 150x150 nt) will be performed on the Illumina HiSeq platform.

At early planning stage of study - undecided.

Jayne Woodside, PhD

Professoe

Queen's University, Belfast

University College Dublin

Harvard School of Public Health

Randomised parallel group dietary intervention: two group.

All outcomes will be conducted blind, including the primary outcome (diet quality score), laboratory analysis and cardiometabolic health marker assessment.

l cysteine/ожиріння

Evaluation of Thiosulfate in End Stage Renal Disease and Kidney Transplantation

The Efficacy of Individualized Dietary Advice in Improving Diet Quality and Cardiovascular Health

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