NCT05104242: Transplant LAD

Kidney Transplant Low-AGE Diet Study

Completed NA Results posted Last updated 6 December 2024

What this trial tests

NA trial testing Diet low in Advanced Glycation End-Products (AGE) in Renal Transplant in 38 participants. Completed in 31 December 2022.

Timeline

4 February 2022

Primary endpoint
8 December 2022

31 December 2022

Quick facts

Lead sponsor	University Hospitals of Derby and Burton NHS Foundation Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	38
Start date	4 February 2022
Primary completion	8 December 2022
Estimated completion	31 December 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• Diet low in Advanced Glycation End-Products (AGE)

Conditions studied

• Renal Transplant — all drugs for Renal Transplant →

Sponsor

University Hospitals of Derby and Burton NHS Foundation Trust

Who can join

18 and older, any sex, with Renal Transplant. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Skin Autofluorescence (SAF) Levels at 6 Months Primary · 6 months

Tissue accumulation of advanced glycation end-products was assessed by measuring skin autofluorescence (SAF) using a validated Autofluorescence Reader. SAF is calculated as the ratio between emission and excitation and is expressed as arbitrary units (AU). Three measurements were conducted and the average value of these was used for statistical analysis. SAF reference value for the age group of 50-60 years is 2.1±0.4 AU

Group	Value	95% CI
Standard Diet - Control Group	2.8	± 0.6
Low AGE Diet - Intervention Group	2.8	± 0.5

Participant Adherence to Diets Secondary · 6 months

Adherence to the low AGE diet (achieving dietary AGE intake \<8000 kilounits \[kU\]/day) and the standard diet for persons with a kidney transplant was evaluated by means of a 3-day food diary (2 weekdays and 1 weekend day) every month (i.e., assessed from 1-6 months but only adherence at 6 months was reported).

Group	Value	95% CI
Standard Diet - Control Group	17
Low AGE Diet - Intervention Group	9

Skin Autofluorescence (SAF) Trend. Secondary · 0, 3 and 6 months

SAF was measured at baseline, 3 and 6 months. The rate of change of SAF among these 3 time points (i.e., SAF trend) was then calculated by fitting a regression line using the SLOPE function in Microsoft Excel 2016, where the y-axis represented SAF values and the x-axis represented time points.

Group	Value	95% CI
Standard Diet - Control Group	-0.22	± 0.75
Low AGE Diet - Intervention Group	-0.45	± 1.19

Dietary AGE Intake at 6 Months Secondary · 6 months

A validated food frequency questionnaire was used to quantify the content of AGEs in foods.

Group	Value	95% CI
Standard Diet - Control Group	20447	14093 – 25044
Low AGE Diet - Intervention Group	5515	4206 – 8631

Sponsor's own description

The purpose of the present study is to test the feasibility of conducting a larger randomised controlled trial (RCT) which will investigate whether a diet low in toxins called advanced glycation end-products (AGEs) decreases skin autofluorescence (SAF; AGE accumulation in the skin) levels and improves heart and circulatory (i.e. cardiovascular) health in persons with a kidney transplant.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.