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

Study Overview
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Brief Summary
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To evaluate the impact of a Low Carbohydrate Ketogenic Diet (LCKD) weight loss program and compare to the standard of care program established for patients with Non-Alcoholic Fatty Liver Disease (NAFLD) on: (1) Liver fat and liver stiffness scores, (2) lipid profile and insulin sensitivity; and (3) depression scores and quality of life, and (4) Cardiometabolic measures such as cardiopulmonary exercise test (CPET) and transthoracic echocardiogram (TTE).

Detailed Description
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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

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

Conditions
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Obesity, Fatty Liver, Ketogenic Dieting

Intervention / Treatment
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* Other: Fibroscan changes with different diets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ketogenic diet exposed group<br>Fibroscan changes with different diets: Patients in a weight loss program using a ketogenic diet. Will compare differences in Fibroscan and metabolic changes. | Other: Fibroscan changes with different diets<br>* Observational study of liver fat and stiffness and cardiometabolic parameters comparing two different standard of care dietary regimens<br>|
| NAFLD diet exposed group<br>Fibroscan changes with different diets: Patients in a NAFLD clinic using low calorie, low fat diet. Will compare differences in Fibroscan and metabolic changes. | Other: Fibroscan changes with different diets<br>* Observational study of liver fat and stiffness and cardiometabolic parameters comparing two different standard of care dietary regimens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in liver fat and stiffness scores compared to control group as well as intrasubject trend | Performed with a fibroscan | 0, 3, 6, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cardiometabolic labs | Lipids, A1c, Insulin, comprehensive metabolic panel | 0, 6, 12 months (3 and 9 months for A1c if >7 | 
| Other specialized testing | Echo, cardiopulmonary exercise testing, room calorimetry | Only to a few of the eligible patients, 0, 3, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketosis, NAFLD, Obesity