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Can a Pre-Donation diet boost kidney health?

NCT ID NCT05709600

Knowledge-focused Sponsor: University of Cologne Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looks at whether special diets—like a fasting-mimicking diet, a ketogenic diet, or a low-sulfur diet—can change the molecular makeup of kidney tissue before living donation. Researchers will analyze proteins, fats, and genetic material in kidney biopsies from 80 donors. The goal is to understand how diet might protect the kidney and improve transplant success.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fasting mimicking diet (Prolon®), ketogenic diet, dietary restriction of sulfur-containing amino acids
What this could lead to
If successful, this could reveal how specific diets prepare kidneys for transplantation, potentially improving donor recovery and transplant outcomes.
What could go wrong
This is a small, early-stage study (80 participants) focused on molecular changes, not clinical outcomes. The diets may not produce meaningful differences, and results may not apply to all donors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients \> 18 years of age * Planed living kidney transplantation (both donor and recipient are eligible) * Written informed consent Exclusion Criteria: * Vegetarian lifestyle * Body-Mass-Index (BMI) \< 18.5 kg/m2 * Calorie-reduced diet within the preceding four weeks * Underlying wasting syndrome * Contraindication for enteral nutrition * Known allergy to or intolerance of the ingredients of the diet used * Pregnancy * Breastfeeding * Absence of safe contraceptive measures or non-occurrence of menopause (in women) * Participation in other interventional trials

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Conditions

The condition(s) this trial relates to.

acute kidney injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Living kidney donors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department II of Internal Medicine, Center for Molecular Medicine Cologne (CMMC), University Hospital of Cologne

    RECRUITING

    Cologne, 50931, Germany

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