Clinical trial NCT03141008: Evaluation of Liver and Cardiometabolic Health Benefits on Low Carbohydrate Ketogenic Diet
Official title: Evaluation of Liver and Cardiometabolic Health Benefits on Low Carbohydrate Ketogenic Diet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Fatty Liver
Ketogenic Dieting
Keywords: Ketosis
NAFLD
Obesity
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Obesity Treatment Foundation
First posted: 2017-05-04
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 people from the PI's weight loss clinic using an a priori ketogenic diet. Will be compared with 50 people from a NAFLD clinic using a low calorie, low fat diet.

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in liver fat and stiffness scores compared to control group as well as intrasubject trend
timeFrame: 0, 3, 6, 12 months
Secondary outcomes:
measure: Change in Cardiometabolic labs
timeFrame: 0, 6, 12 months (3 and 9 months for A1c if >7
measure: Other specialized testing
timeFrame: Only to a few of the eligible patients, 0, 3, 12 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: VCU
name: Susan Wolver, MD
role: PRINCIPAL_INVESTIGATOR
References:
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