Evaluation of Liver and Cardiometabolic Health Benefits on Low Carbohydrate Ketogenic Diet

This prospective pilot pragmatic trial will investigate the role of a LCKD weight loss
program for obese patients (BMI ≥30 kg/m2) and compare it to the group of known obese NAFLD
patients who receive dietetic counseling as part of their standard of care in a dedicated
NAFLD program. All participants (n=50) will be recruited at Virginia Commonwealth University
(VCU).

Patients will do initial paperwork including

Questionnaires QOL, eating disorder screen, depression screen:

QOL, eating disorder screen and depression screen.

Labwork:

Data will be collected from routine care labwork to include a fasting cholesterol panel,
insulin, A1c and comprehensive panel (if they have not received these labs in the preceding 3
months), and at 6 and 12 months. A1c will be collected at 3,6,9 months as well (if A1c >/=7),
or just additionally at 6 months if A1c <7

Study labs will be collected:

Blood at 0, 3, 6 and 12 months Urine, stool and saliva at 0, 1, 3 and 12 months

Fibroscan will be done at 0, 3, 6 and 12 months

Echo/CPET testing and Room calorimetry will be offered and the patients agreeing to do this
will have them done at 0, 3 and 12 months

Inclusion Criteria:

- The inclusion criteria include patients aged 18 years and older, BMI ≥ 30, ALT
(alanine transferase) > 19 (female) and > 30 (male) or radiographic evidence of
hepatic parenchymal disease and seen in either the PIs weight loss clinic or a patient
in the VCU NAFLD (non-alcoholic fatty liver disease) program.

Exclusion Criteria:

- Patients will be excluded if they have known other liver disease such as viral
hepatitis, autoimmune hepatitis, liver transplant, severely ill, weekly alcohol use
(>14 drinks in men and >7 drinks in women), HIV, pregnant females, those< 18 years,
and prisoners.