Kidney Transplant Low-AGE Diet Study

NCT05104242 | Completed Results

• 1 other identifier: UHDB/2020/018
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Transplant

Outcome Measures

Primary Outcomes (1)

• Skin Autofluorescence (SAF) Levels at 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

  6 months

Secondary Outcomes (3)

• Participant Adherence to Diets

  6 months

• Skin Autofluorescence (SAF) Trend.

  0, 3 and 6 months

• Dietary AGE Intake at 6 Months

  6 months

Study Arms (2)

Standard diet - Control group

NO INTERVENTION

The standard diet will include energy intake of 30-35 kcal/kg of ideal body weight (IBW)/day and protein intake of 0.75 g/kg of IBW/day for females and 0.84 g/kg of IBW/day for males

Low AGE diet - Intervention group

EXPERIMENTAL

The low AGE diet will be the same as the standard diet in terms of calories (i.e. 30-35 kcal/kg/day) and protein (0.75-0.84 g/kg/day). However, it will reduce the dietary AGE content by changing cooking methods in food preparation to avoid exposure to dry heat such as frying, broiling, grilling and roasting, and to favour cooking with lower temperatures and high-water content as in stewing, steaming, boiling and poaching. In addition, the low-AGE group will be instructed to choose foods with low content of AGEs based on a food choice list that will contain examples of foods commonly available in the UK to be chosen as "allowed," "moderate intake," or "occasional." The goal will be to reduce dietary AGE intake to less than 8000 kU/day.

Other: Diet low in Advanced Glycation End-Products (AGE)

Interventions

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

The low AGE diet will primarily consist in reducing the amount of AGEs in foods by changing cooking methods. Participants will also be advice to choose foods low in AGEs; however, the advice will be tailored to participants' food preferences

Low AGE diet - Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (\>18 years) with a functioning (not on dialysis) kidney transplant.
• More than 12 months post-transplant.
• Able and willing to give informed consent.
• Skin Autofluorescence levels above the general population mean value for age.

You may not qualify if:

• Persons with dark skin colour (i.e. Fitzpatrick skin colour type 5-6).
• Persons with malnutrition (Subjective Global Assessment \[SGA\] score \<5).
• Pregnancy or breast feeding or intending pregnancy.
• Active infection.
• Active rejection.
• Persons with learning difficulties.
• Prisoners.

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust: lead
• British Renal Society: collaborator
• Kidney Care UK: collaborator

Study Sites (1)

University Hospitals of Derby and Burton NHS Foundation Trust

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

MeSH Terms

Interventions

Glycation End Products, Advanced

Intervention Hierarchy (Ancestors)

Glycoconjugates; Carbohydrates; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Catherine Johnson
• Organization: University Hospitals of Derby & Burton NHS Foundation Trust, Royal Derby Hospital

catherine.johnson16@nhs.net

01332 789354

Study Officials

• Catherine Johnson

  University Hospitals of Derby and Burton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: February 4, 2022
• Primary Completion: December 8, 2022
• Study Completion: December 31, 2022
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)