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

ConditionsLymphedemaKetogenic DietingKetone Ester Supplement
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Ketogenic diet

    Dietary supplement

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

  • Isocaloric diet

    Dietary supplement

    Patients will follow an isocaloric diet

  • Ketone ester supplementation

    Dietary supplement

    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.

Treatment groups

81 Participants
are divided into 3 treatment groups
Group A: Ketogenic dietExperimental treatment 1 intervention
Group B: Isocaloric dietActive comparator 1 intervention
Group C: Ketone ester supplementationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in lymphatic transport

Measured with lymphoscintigraphy

Time frame
Up to 12 weeks
2

Change in lymphatic transport

Measured by lymphofluoroscopy

Time frame
up to 12 weeks

Secondary outcomes

1

Change in edema volume

Measured with tape circumference

Time frame
12 weeks
2

Change in edema volume

measured with volumeter

Time frame
12 weeks
3

Changed quality of life

measured with Lymph ICF (international classification of functioning, disability and Health), a scale from 0-10 on 29 items, total score ranged from 0-100, 0-4: indicate no problem; 5-24 a small problem; 26-49: moderate problem; 50-95: severe problem; 96-100: very severe problem

Time frame
12 weeks
4

Lymphatic function at 6 months

Change in dermal backflow score at 6-month follow-up

Time frame
6 months

Other outcomes

1

Cost-effectiveness

Difference in cost-effectiveness between nutritional ketosis, induced by either consumption of a CKD or ingestion of KE supplements, and a healthy diet at 6-month follow-up.

Time frame
up to 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Source ClinicalTrials.gov
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