Diet and COVID-19 Vaccination
Obesity
About this trial
This is an interventional treatment trial for Obesity focused on measuring Ketogenic Diet, COVID-19, VAT, Obesity
Eligibility Criteria
- BMI ≥35.0 kg/m2 with comorbidities or BMI≥40
- Stable body weight (less than 5 kg self-reported change during the previous 3 months)
- Informed consent obtained before any trial-related activity takes place Exclusion criteria
- Stage 3-5 CKD (GFR<60 ml/min)
- Type 1 diabetes
- Uncontrolled type 2 diabetes
- Previous infection with SARS CoV-2
- Immunodeficiency or immunomodulating treatment
- Treatment with anti-obesity medications or other medications potentially affecting body weight or SGLT2 inhibitors
- Pregnancy and lactation
- Previous gout episodes
- Cardio and cerebrovascular accidents in the preceding 12 months
Sites / Locations
- Sapienza University of RomeRecruiting
Arms of the Study
Arm 1
Experimental
Ketogenic Diet-obese
LCKD (1200-1400kcal/day) low in carbohydrates (<50g per day) with a moderate protein intake (1-1.5g/kg of ideal body mass) but otherwise no other dietary restrictions. The participants will be counselled by a trained nutritionist at baseline and every two weeks, and compliance will be assessed through a 3-day dietary recall at each follow up visit and capillary beta hydroxybutyrate levels as well as urinary acetoacetate levels. The follow up visits take place at the time of the first vaccine dose, two weeks after the first vaccine dose, one week after the second vaccine dose. Then, gradual reintroduction of carbohydrates will take place following the second vaccine dose.