NCT03784716

Ketogenic Diet in Non-alcoholic Fatty Liver Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Marc Goodman · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2019-03-13
• Primary completion: 2022-02-10
• Completion: 2022-02-10
• First posted: 2018-12-24
• Last updated: 2022-05-11

Locations

1 site across 1 country: United States