An interventional study of Ketogenic Diet and Standard Weight Loss Diet in Fatty Liver, Nonalcoholic and Liver Diseases, sponsored by Marc Goodman. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-11.
Sponsored by Marc Goodman · Not applicable, Interventional, and Treatment
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.
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 24 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Marc Goodman is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Prior diagnosis of liver cirrhosis as defined by any of the following criteria:
Unstable cardiovascular disease as defined by any of the following:
Ketogenic Diet for 28 Days
Other: Ketogenic Diet
Standard Weight Loss Diet for 28 Days
Other: Standard Weight Loss 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.
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.
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
Time frame: 28 days
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.
Time frame: 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
Time frame: 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
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.
The University of Pennsylvania Smell IdentificationTest (UPSIT) uses 40 microencapsulated odors embedded in questionnaire accompanied by multiple choice questions containing the correct odor.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: 28 days
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Marc Goodman