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

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT03991897
Status
Recruiting
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Conditions

  • Ketogenic Dieting
  • Ketone Ester Supplement
  • Lymphedema

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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 Dates

First listed
Jun 19, 2019
Start date
Oct 1, 2025
Status verified
Aug 2025
Primary completion
Feb 1, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
81 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in lymphatic transport [ Time Frame: Up to 12 weeks ]

Central Contacts

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