Fatty Liver, NonalcoholicNCT03784716
Ketogenic Diet in Non-alcoholic Fatty Liver Disease
A study testing Ketogenic Diet and Standard Weight Loss Diet in people with Fatty Liver, Nonalcoholic and Liver Diseases, run by Marc Goodman at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatty Liver, Nonalcoholic, Liver Diseases
- What is being tested?
- Ketogenic Diet and Standard Weight Loss Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2019to 10 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Ke-To Liver Health Study: A Randomized Controlled Trial to Study the Effects of a 28-day Ketogenic Dietary Intervention on Non-alcoholic Fatty Liver Disease Progression
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.
Read the 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
- Being tested
- Ketogenic Diet, Standard Weight Loss Diet
- Keywords
- Fatty Liver, Liver Disease, Ketogenic diet, Keto diet
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Diseases, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic DietOther
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 DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet | Experimental | Ketogenic Diet for 28 Days Receives: Other: Ketogenic Diet |
| Standard Weight Loss Diet | Active comparator | Standard Weight Loss Diet for 28 Days Receives: Other: Standard Weight Loss Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (9)
Mean change in liver stiffness measured by magnetic resonance elastography (MRE) from baseline to 28 days following diet initiation.
Stiffness will be measured by MRE (kPa), a quantitative imaging test that uses sound vibrations to assess the mechanical properties of the liver.
Measured: 28 days
Mean change in liver enzyme, aspertate aminotransferase (AST), from baseline to 28 days following diet initiation.
AST will be measured from blood test at baseline and 28 days from diet initiation
Measured: 28 days
Mean change in liver enzyme, Alanine Aminotransferase (ALT), from baseline to 28 days following diet initiation.
ALT will be measured from blood test at baseline and 28 days from diet initiation
Measured: 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.
The University of Pennsylvania Smell IdentificationTest (UPSIT) uses 40 microencapsulated odors embedded in questionnaire accompanied by multiple choice questions containing the correct odor.
Measured: 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.
Sweet taste intensity will be rated on a 100mm general Labeled Magnitude Scale (gLMS) ranging from no sensation (0 mm) to strongest imaginable sensation (100 mm). The mean difference in scores will be calculated at 28 days following diet initiation and baseline.
Measured: 28 days
Mean change in patient-reported cognitive function measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) scale from baseline to 28 days following diet initiation.
Cognitive function will be assessed using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) short form, which includes 8 items and a range of 1 to 5 (worst outcome). The total score will be calculated and converted into a standardized t-score will be calculated based on a standard population with a mean of 50 and SD of 10.
Measured: 28 days
Mean change in patient-reported constipation measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) scale from baseline to 28 days following diet initiation.
Constipation will be assessed using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) short form, which includes 9 items and a range of 1 (low constipation) to 5 (high constipation). The total score will be calculated and converted into a standardized t-score will be calculated based on a standard population with a mean of 50 and SD of 10.
Measured: 28 days
Mean change in patient-reported fatigue measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) scale from baseline to 28 days following diet initiation.
Fatigue will be assessed using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) short form, which includes 8 items and a range of 1 (low fatigue) to 5 (high fatigue). The total score will be calculated and converted into a standardized t-score will be calculated based on a standard population with a mean of 50 and SD of 10.
Measured: 28 days
Mean change in physical activity measured by a wearable activity monitor from baseline to 28 days following diet initiation.
A 7-day average at 28 days will be compared to 7-day baseline activity where at least 4 of 7 days of recorded activity required.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start13 Mar 2019
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Liver, NonalcoholicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marc Goodman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marc Goodman, Cedars-Sinai Medical Center
- Investigators
- Marc Goodman, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784716
- Sponsor's protocol ID
- IIT2018-27-Hussain-KetoLi
- Status last verified
- May 2022
- First submitted
- 4 Dec 2018
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ke-To Liver Health Study: A Randomized Controlled Trial to Study the Effects of a 28-day Ketogenic Dietary Intervention on Non-alcoholic Fatty Liver Disease Progression
- ClinicalTrials.gov ID
- NCT03784716
- Acronym / sponsor ID
- IIT2018-27-Hussain-KetoLi
- Conditions
- Fatty Liver, Nonalcoholic, Liver Diseases
- Keywords
- Fatty Liver, Liver Disease, Ketogenic diet, Keto diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Marc GoodmanUniversity, hospital or other
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet | Experimental | Other: Ketogenic DietKetogenic Diet for 28 Days |
| Standard Weight Loss Diet | Active comparator | Other: Standard Weight Loss DietStandard Weight Loss Diet for 28 Days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (27 listed)
- 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:
- History of liver transplantation
- Body mass index (BMI) less than 27 kg/m
- Unstable body weight (> 10% change in prior 3 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic DietKetogenic 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. | Other | Ketogenic Diet |
| Standard Weight Loss DietStandard 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. | Other | Standard Weight Loss Diet |
Primary outcome
Mean change in intrahepatic triglyceride content measured by MRI-proton density fat fraction (MRI-PDFF) from baseline to 28 days following diet initiation.
Time frame: 28 days
The MRI-PDFF is a quantitative imaging test that exploits the differences in resonance frequencies between
9 secondary outcomes
Mean change in liver stiffness measured by magnetic resonance elastography (MRE) from baseline to 28 days following diet initiation.
Time frame: 28 days
Mean change in liver enzyme, aspertate aminotransferase (AST), from baseline to 28 days following diet initiation.
Time frame: 28 days
Mean change in liver enzyme, Alanine Aminotransferase (ALT), from baseline to 28 days following diet initiation.
Time frame: 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.
Time frame: 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.
Time frame: 28 days
Mean change in patient-reported cognitive function measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) scale from baseline to 28 days following diet initiation.
Time frame: 28 days
Mean change in patient-reported constipation measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) scale from baseline to 28 days following diet initiation.
Time frame: 28 days
Mean change in patient-reported fatigue measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) scale from baseline to 28 days following diet initiation.
Time frame: 28 days
Mean change in physical activity measured by a wearable activity monitor from baseline to 28 days following diet initiation.
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Goodman, PhD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic Diet and Standard Weight Loss Diet in people with Fatty Liver, Nonalcoholic and Liver Diseases, run by Marc Goodman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in intrahepatic triglyceride content measured by MRI-proton density fat fraction (MRI-PDFF) from baseline to 28 days following diet initiation. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.