Hepatocellular Adenoma (HCA), an uncommon, solid, benign liver lesion. Typically, it is a solitary lesion found in young women within their reproductive years.
Conditions
Interventions
All subjects will receive a diet for 6 months (see table 1 & 2 for the example diet). In this ketogenic diet the amount of carbohydrates is restricted, the first three months to approximately 35 grams
Sponsors
Investigator Initiated
Eligibility
Inclusion criteria
Inclusion criteria: - Age 18-50 years - BMI > 25 kg/m2 - Provide written consent
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Current pregnancy or breastfeeding - Diabetes Mellitus type 1 or 2 - Insufficient understanding of the Dutch language - Participation in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our main study endpoint is the difference in tumour regression. The size (largest diameter in cm) of the largest hepatocellular adenoma found on MRI will be measured at T0 = time of inclusion and at T5= 6 months after start of the intervention. Mean regression will be calculated after which it will be compared to the regression in tumour size of our (earlier acquired) cohort. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life, change in body weight, body composition, resting energy expenditure and plasma parameters. | — |
Contacts
Public ContactC.A.J. Oudmaijer
Erasmus MC, University Medical Center Rotterdam
Outcome results
None listed