Potential therapeutic effect of a ketogenic diet for the treatment of lymphoedema: Results of an exploratory study.
Inge Lodewijckx, Christophe Matthys, Joke Verheijen...
https://pubmed.ncbi.nlm.nih.gov/38837503Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID03991897
Nutritional Ketosis: a Novel Metabolic Strategy to Treat Lymphedema Patients?
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-12-03
81
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Brief Title
Nutritional Ketosis: a Novel Metabolic Strategy to Treat Lymphedema Patients?
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Unilateral arm lymphedema caused by lymph node dissection
- Lymphedema started less than one year before starting therapy
- Lymphedema defined as more than 3% volume difference between arms
- Lymphedema stage 1, 2a, or 2b
- Not pregnant at enrollment and willing to use contraception until study end
- Able to give oral and written informed consent
- Understands Dutch language
You will not qualify if you...
- Under 18 years old
- Limb edema caused by other reasons or later stage/onset than specified
- Presence of active cancer
- Pregnant or actively breastfeeding
- Unable to participate for the entire study period
- Mentally or physically unable to participate
- Serious illness such as gastrointestinal intolerance, renal failure, liver dysfunction, heart failure, or neurological impairment
- Presence of diabetes or other metabolic disease
- Allergy to indocyanine green (ICG) or iodine, or hyperthyroidism contraindicating ICG use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
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
Treatment
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
Follow-up
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
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
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Research Team
S
Sarah Thomis, MD
C
Christoph Matthys, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
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