Ketogenic Diet in Non-alcoholic Fatty Liver Disease

NCT03784716 | Completed DMC

• 1 other identifier: IIT2018-27-Hussain-KetoLi
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatty Liver, Nonalcoholic; Liver Diseases

Keywords

Fatty Liver; Liver Disease; Ketogenic diet; Keto diet

Outcome Measures

Primary Outcomes (1)

• Mean change in intrahepatic triglyceride content measured by MRI-proton density fat fraction (MRI-PDFF) from baseline to 28 days following diet initiation.

  The MRI-PDFF is a quantitative imaging test that exploits the differences in resonance frequencies between

  28 days

Secondary Outcomes (9)

• Mean change in liver stiffness measured by magnetic resonance elastography (MRE) from baseline to 28 days following diet initiation.

  28 days

• Mean change in liver enzyme, aspertate aminotransferase (AST), from baseline to 28 days following diet initiation.

  28 days

• Mean change in liver enzyme, Alanine Aminotransferase (ALT), from baseline to 28 days following diet initiation.

  28 days

• Mean change in number of odors correctly identified using 40 microencapsulated odors in the smell identification test (UPSIT) from baseline to 28 days following diet initiation.

  28 days

• Mean change in perceived sweet taste tested with glucose solutions and a general Labeled Magnitude Scale (gLMS) from baseline to 28 days following diet initiation.

  28 days

Study Arms (2)

Ketogenic Diet

EXPERIMENTAL

Ketogenic Diet for 28 Days

Other: Ketogenic Diet

Standard Weight Loss Diet

ACTIVE COMPARATOR

Standard Weight Loss Diet for 28 Days

Other: Standard Weight Loss Diet

Interventions

Ketogenic Diet 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.

Ketogenic Diet

Standard Weight Loss Diet 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.

Standard Weight Loss Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marc Goodman: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases; Fatty Liver

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Marc Goodman, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator; Director Cancer Prevention and Control; Professor, Department Cancer Institute

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 24, 2018
• Study Start: March 13, 2019
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

US (1)