Keto diet tested as new treatment for swollen limbs

NCT ID NCT03991897

Disease control Sponsor: Universitaire Ziekenhuizen KU Leuven Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a ketogenic diet or ketone supplements can improve lymphatic function in people with lymphedema, a condition causing arm swelling after lymph node removal. 81 participants will be randomly assigned to a ketogenic diet, an isocaloric diet, or ketone supplements for 12 weeks. The goal is to see if these dietary changes can reduce swelling and improve quality of life.

What this could mean

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

Active substance: ketogenic diet and ketone ester supplement
What this could lead to: If it works, this could point toward a new dietary strategy to improve lymphatic drainage and reduce swelling in lymphedema patients.
What could go wrong: This is an early-stage trial with only 81 participants, so results may not apply to everyone. The diet is strict and may be hard to follow, and side effects like 'keto flu' are possible.

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 81 people

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

Started

Oct 2025

Expected to finish

Aug 2028

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * \>18 years; * unilateral lymphedema of the arm lymph node dissection * lymphedema onset less than a year before the therapy starts * lymphedema defined as \>3% volume difference between both arms * lymphedema stage 1, stage 2a or stage 2b * absence of pregnancy at the time of enrollment and willingness to use adequate contraceptive measures until the end of the study; * oral and written approval of the informed consent presented at the time of the consultation by the physicians; * understanding Dutch Exclusion Criteria: * \<18 years; * edema of the limb with different etiology or later stage/onset as specified in the inclusion criteria; * presence of active cancer * pregnancy or active breastfeeding; * impossibility to participate for the entire study period; * mentally or physically unable to participate to the study; * presence of gastrointestinal intolerance or other serious illness (e.g. renal failure, hepatic dysfunction, heart failure, neurological impairment); * presence of diabetes or other metabolic disease; * contra-indication for the use of indocyanine green (ICG): allergy to ICG or iodine, hyperthyroidism.

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Conditions

The condition(s) this trial relates to.

Ketosis lymphedema

As listed by the trial registrant

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

Ketogenic dieting Ketone ester supplement Lymphedema

How to take part

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

The places running it

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

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

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A doctor treating you

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Keto diet tested as new treatment for swollen limbs

What the study statuses mean