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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \>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

Locations
Other Locations
Belgium
UZ Leuven
RECRUITING
Leuven
Contact Information
Primary
Sarah Thomis, MD
sarah.thomis@uzleuven.be
003216346948
Backup
Christoph Matthys, PhD
christophe.matthys@uzleuven.be
003216342655
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2028-08-01
Participants
Target number of participants: 81
Treatments
Experimental: Ketogenic diet
the intervention will consist of 3 phases: a two week run-in period, 12 weeks strict KD and 6 months Modified Atkins Diet.~During the run-in period, patients will become familiar with their diet and, in particular, they will learn which foods are allowed and which are not. Ketogenic ratio wil build up to 3:1 - 4:1, ensuring protein needs.
Active_comparator: Isocaloric diet
During the run-in period, the dietician will discuss the diet and maintenance of an isocaloric diet with the patients. As such, the diet of the control group will not change from their normal dietary pattern. In the latter case, the patient will be asked to change the diet to a normal Belgian diet, according to Flemisch dietary guidelines.
Experimental: Ketone ester supplementation
Arm Description: the intervention will consist of 3 phases: a two week run-in period, 12 weeks strict of Ketone ester supplementation and 6 months of the follow-up with a healthy diet. Ke supplements will be ingested 3 times a day separately from a meal in fixed doses of 25g. If blood β-OHB levels are substantially below 3mmol/L, a weight-based dosing of the KEs (up to 0.5g/kg bodyweight), rather than a fixed dosing strategy, will be utilized.
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov