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

Completed

• Conditions: Obesity; Ketogenic Dieting; Fatty Liver
• Interventions: Other: Fibroscan changes with different diets

• Registration Number: NCT03141008
• Lead Sponsor: Virginia Commonwealth University

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-18
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-04
• Study Start: 2017-09-15
• Primary Completion: 2020-02-27
• Study Completion: 2020-02-27
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ketogenic diet exposed group	Fibroscan changes with different diets	Fibroscan changes with different diets: Patients in a weight loss program using a ketogenic diet. Will compare differences in Fibroscan and metabolic changes.
NAFLD diet exposed group	Fibroscan changes with different diets	Fibroscan changes with different diets: Patients in a NAFLD clinic using low calorie, low fat diet. Will compare differences in Fibroscan and metabolic changes.

Primary Outcome Measures

Name	Time	Method
Change in liver fat and stiffness scores compared to control group as well as intrasubject trend	0, 3, 6, 12 months	Performed with a fibroscan

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States