Ketogenic Diet in Non-alcoholic Fatty Liver Disease

NCT ID: NCT03784716

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-13
• Study Completion Date: 2022-02-10

Brief Summary

The purpose of this randomized trial is to examine the effects of a ketogenic diet on non-alcoholic fatty liver disease (NAFLD). Twenty-four participants with NAFLD will be randomized to receive a ketogenic meal plan or control (standard weight loss meal plan). Participants will be followed up to 28 days after initiation of the diet intervention.

Detailed Description

We will conduct a randomized trial to examine the effects of a ketogenic diet on non-alcoholic fatty liver disease (NAFLD). Twenty-four participants with NAFLD will be randomized into one of two groups: 12 participants will be randomized to receive a ketogenic meal plan and 12 participants will be randomized to receive a standard weight loss meal plan. There will be one screening visit and three study visits: the baseline visit, and follow-up visits 14 days and 28 days after initiation of the diet intervention. The study team hypothesizes that participants randomized to a ketogenic diet will have a greater reduction in intrahepatic triglycerides compared to those randomized to a standard weight loss diet.

Conditions

Fatty Liver, Nonalcoholic; Liver Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketogenic Diet

Ketogenic Diet for 28 Days

Group Type: EXPERIMENTAL

Ketogenic Diet

Intervention Type: OTHER

Ketogenic diet for 28 days. Meals will be provided to all study participants for 28 days by a prepared meal delivery service. Daily caloric needs for each participant will be determined based on height, weight, gender, age, and activity level. Meals will be prepared based on compliance with the following macronutrient guidelines: 70% fat, 25% protein, and 5% carbohydrate for the ketogenic diet.

Standard Weight Loss Diet

Standard Weight Loss Diet for 28 Days

Group Type: ACTIVE_COMPARATOR

Standard Weight Loss Diet

Intervention Type: OTHER

Standard weight loss diet for 28 days. Meals will be provided to all study participants for 28 days by a prepared meal delivery service. Daily caloric needs for each participant will be determined based on height, weight, gender, age, and activity level. Meals will be prepared based on compliance with the following macronutrient guidelines: 30% fat, 20% protein, and 50% carbohydrate for the standard weight loss diet.

Interventions

Ketogenic Diet

Ketogenic diet for 28 days. Meals will be provided to all study participants for 28 days by a prepared meal delivery service. Daily caloric needs for each participant will be determined based on height, weight, gender, age, and activity level. Meals will be prepared based on compliance with the following macronutrient guidelines: 70% fat, 25% protein, and 5% carbohydrate for the ketogenic diet.

Intervention Type: OTHER

Standard Weight Loss Diet

Standard weight loss diet for 28 days. Meals will be provided to all study participants for 28 days by a prepared meal delivery service. Daily caloric needs for each participant will be determined based on height, weight, gender, age, and activity level. Meals will be prepared based on compliance with the following macronutrient guidelines: 30% fat, 20% protein, and 50% carbohydrate for the standard weight loss diet.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age greater than or equal to 18 years at enrollment
• Diagnosis of NAFLD verified by screening MRI-PDFF greater than or equal to 8%
• Women able to become pregnant must have a confirmed negative pregnancy test result prior to enrollment because MRI is contraindicated in pregnant women. Women ≥ 50 years of age who have not had a menstrual period in the past year; and women who have had a hysterectomy, both ovaries removed, or a tubal ligation; will not be required to have a pregnancy test.
• Women able to become pregnant must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
• Ability to understand and the willingness to sign a written informed consent document and medical release
• Willing and able to comply with trial protocol and follow-up

Exclusion Criteria

• Prior diagnosis of chronic liver disease other than NAFLD, including autoimmune, viral, and alcoholic liver disease
• Prior diagnosis of liver cirrhosis as defined by any of the following criteria:

• Cirrhosis on historical liver biopsy; or
• Evidence of cirrhosis on liver imaging (CT, MRI, or US) including a nodular liver surface, splenomegaly, or portal venous collaterals; or
• Prior history of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding; or
• FibroScan value of >14.9 kPa; or
• MRE of 4.67 kPa or higher
• History of liver transplantation
• Body mass index (BMI) less than 27 kg/m
• Unstable body weight (> 10% change in prior 3 months)
• Prior weight reduction surgery within the last 5 years
• Use of a medication prescribed for weight loss within the past 3 months
• Current alcohol consumption >21 oz. per week for males or >14 oz. per week for females (1 oz./30 mL of alcohol is present in one 12 oz./360 mL beer, one 4 oz./120 mL glass of wine, and one 1 oz./30 mL measure of 40% proof alcohol)
• Unstable cardiovascular disease as defined by any of the following:

• Unstable angina within 6 months prior to screening
• Myocardial infarction, coronary artery bypass graft surgery or coronary angioplasty within 6 months prior to screening
• Transient ischemic attack or cerebrovascular accident within 6 months prior to screening
• Obstructive valvular heart disease or hypertrophic cardiomyopathy
• Unstable congestive heart failure
• Women who are pregnant or breastfeeding or are implanted with intrauterine devices that are not MRI-compatible
• Active malignancy within the past 5 years (excluding basal/squamous cell skin cancer, or prostate cancer with a Gleason score 6 or less)
• Known HIV infection
• Food allergies or dietary restrictions, including vegan or vegetarian diet, which cannot be accommodated with the prepared meal service
• Contraindication to undergo MRI-PDFF or MRE, including persons with mechanically, magnetically, or electrically activated implants, such as cardiac pacemakers or defibrillators, or infusion pumps; or ferromagnetic implants or foreign bodies, such as aneurysm clips or shrapnel; or other implanted electronic devices or metallic parts in the body prohibiting MRI. Because the MRI scanner is also used with animals, persons with allergy to animal dander or animal-instigated asthma are also excluded.
• Resides outside of the meal delivery zone or plans to travel outside of the meal delivery zone for more than one day while on the study intervention and will be unable to access the meal delivery
• Current use of any investigational agents
• Concurrent illness or abnormal laboratory result which in the opinion of the investigators would compromise either the patient or the integrity of the data

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marc Goodman

OTHER

Sponsor Role: lead

Responsible Party

Marc Goodman

Principal Investigator; Director Cancer Prevention and Control; Professor, Department Cancer Institute

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marc Goodman, PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

IIT2018-27-Hussain-KetoLi

Identifier Type: -

Identifier Source: org_study_id