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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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 criteria

Qualifiers

>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

Disqualifiers

<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;

Trial design

Treatments tested in this trial

  • Ketogenic diet
  • Isocaloric diet
  • Ketone ester supplementation

Treatment groups

81 Participants
are divided into 3 treatment groups