Prevention of Acute Kidney Injury - Molecular Mechanisms of Dietary Pre-conditioning in Human (CR_LSP)

University of Cologne

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Dietary Supplement: protein-restricted diet; Dietary Supplement: low-calorie formula diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02745444

CR_LSP

Details and patient eligibility

About

The key objective of this pilot study is to assess the molecular mechanisms of renal pre-conditioning by a one-week low-calorie diet in humans.

The protective effect of the low-calorie diet and also of the protein-restriction in donor on transplant qualities and functions in receptor will also be investigated.

Analysis of transcriptome, lipidome, metabolome, epigenome, proteome und phosphoproteome through tissue samples as well as blood samples for comparison of low-calorie diet, protein-restriction and no-diet groups.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Competent patients
• Planned living kidney transplantation
• Provision of informed consent
• BMI ≥ 18,5 kg/m²

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

low-calorie formula diet

Other group

Description:

Donor taking low-calorie formula diet, 50% of basal energy rate, individually calculated with Mifflin-St. Jeor formula.

Treatment:

Dietary Supplement: low-calorie formula diet

no diet

No Intervention group

Description:

Donor ingesting food as usual.

protein-restricted diet

Other group

Description:

Donor taking protein-restricted diet according to diet plans of clinical dietetics of University Hospital of Cologne, with unchanged calorie supply, individually calculated with Mifflin-St. Jeor formula.

Treatment:

Dietary Supplement: protein-restricted diet

Normal protein supply

No Intervention group

Description:

Donor taking same dishes as protein-restricted diet group but with customary protein levels, with unchanged calorie supply.