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RECRUITING
NCT03991897
NA

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

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

81

Start Date

2025-10-01

Completion Date

2028-08-01

Last Updated

2025-12-03

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Ketogenic diet

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

DIETARY_SUPPLEMENT

Isocaloric diet

Patients will follow an isocaloric diet

DIETARY_SUPPLEMENT

Ketone 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.

Locations (1)

UZ Leuven

Leuven, Belgium