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

March 9, 2020 updated by: Virginia Commonwealth University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ketogenic diet exposed group

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
Observational study of liver fat and stiffness and cardiometabolic parameters comparing two different standard of care dietary regimens
NAFLD diet exposed group

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
Observational study of liver fat and stiffness and cardiometabolic parameters comparing two different standard of care dietary regimens

What is the study measuring?

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
Time Frame: 0, 3, 6, 12 months
Performed with a fibroscan
0, 3, 6, 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

Obesity Treatment Foundation

Investigators

  • Principal Investigator: Susan Wolver, MD, VCU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2017

Primary Completion (Actual)

February 27, 2020

Study Completion (Actual)

February 27, 2020

Study Registration Dates

First Submitted

April 18, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (Actual)

May 4, 2017

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20009338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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