RecruitingNot ApplicableNCT03991897

Nutritional Ketosis: a Novel Metabolic Strategy to Treat Lymphedema Patients?

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

81 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Lymphedema Ketogenic Dieting Ketone Ester Supplement

Summary

Lymphedema is a debilitating disorder that severely impairs the quality of life of the patients and requires life-long attention. Treatment for lymphatic dysfunction remains largely symptomatic, without real cure. According to the International Society of Lymphology, lymphedema has to be treated with Decongestive Lymphatic Therapy. Research in the lab of Angiogenesis and Vascular Metabolism (PCA lab) reported in mice that metabolism of endothelial cells controls vessel sprouting. Experiments showed that a ketogenic diet (KD) reduced the edema of the mice tail and enhanced the lymphatic transport. Based on these proof-of-concept data, the investigators plan to test this innovative concept to ameliorate lymph vessel dysfunction in lymphedema patients. Randomisation will be performed between a ketogenic diet and an isocaloric diet with and without ketone ester supplementation.

Eligibility

Min Age: 18 Years

Inclusion Criteria15

\>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
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.

Exclusion Criteria1

\<18 years;

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENTKetogenic diet

Multivit and Metarelax. This multivitamin and Magnesium supplement will provide necessary vitamins and decrease ketone-flu sympotms, repsectively.

DIETARY_SUPPLEMENTIsocaloric diet

Patients will follow an isocaloric diet

DIETARY_SUPPLEMENTKetone ester supplementation

25g of a ketone monoester, ingested 3 times a day for a period of 12 weeks. Ingestion is separated from a meal and interspersed by at least 4 hours to ensure maximal available ketone bodies circulating in the blood.