Role and therapeutic potential of dietary ketone bodies in lymph vessel growth.
Melissa García-Caballero, Annalisa Zecchin, Joris Souffreau...
https://pubmed.ncbi.nlm.nih.gov/32694649/Actively Recruiting
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-12-03
81
Participants Needed
1
Research Sites
26 weeks
Total Duration
Lymphedema is a chronic condition that significantly reduces quality of life and requires ongoing management. It can be primary, caused by genetic mutations, or secondary, often due to cancer treatments like surgery or radiotherapy. Current treatments mainly relieve symptoms but do not cure the condition. Researchers are exploring a new approach using a ketogenic diet to improve lymphatic vessel function based on promising results from animal studies. The study compares three groups one following a ketogenic diet KD, one on an isocaloric diet without ketone supplementation, and one with ketone ester supplementation KE alongside an isocaloric diet. The intervention has three phases a two-week run-in period to establish ketosis, followed by 12 weeks of strict KD or KE supplementation, and then 6 months on a Modified Atkins Diet or isocaloric diet for follow-up. Participants receive dietary support from dieticians, and ketosis levels are monitored regularly. Participants will undergo assessments including measurements of lymphatic transport and edema volume over 12 weeks and at 6 months. Regular health checks, body measurements, blood tests, and questionnaires on quality of life and physical activity will be conducted. Weekly group chat sessions will support adherence to the diet. The primary goal is to evaluate changes in lymphatic function and symptom improvements during and after the dietary intervention.
CONDITIONS
Nutritional Ketosis: a Novel Metabolic Strategy to Treat Lymphedema Patients?
S
Sarah Thomis, MD
C
Christoph Matthys, PhD
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Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants learn and adjust to their assigned diet to establish ketosis or maintain an isocaloric diet, with intensive dietician support and daily ketosis monitoring for those in the ketogenic diet group.
Multiple visits and daily home measurements for ketosis monitoring
Duration - 12 weeks
Participants follow their assigned diet strictly for 12 weeks, receiving ongoing support from dieticians and weekly health assessments by researchers, including body measurements and blood tests to monitor metabolic changes and adherence.
Weekly visits for health assessments and weekly chat sessions with a dietician
Duration - 6 months
Participants transition to a less strict Modified Atkins Diet or a healthy diet for 6 months to maintain improvements and support long-term adherence.
Regular follow-up visits to monitor diet adherence and lymphatic function
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Melissa García-Caballero, Annalisa Zecchin, Joris Souffreau...
https://pubmed.ncbi.nlm.nih.gov/32694649/Inge Lodewijckx, Christophe Matthys, Joke Verheijen...
https://pubmed.ncbi.nlm.nih.gov/38837503/Universitaire Ziekenhuizen KU Leuven
Lead Sponsor