Dietary Interventions for Non-Alcoholic Fatty Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different diets might help treat non-alcoholic fatty liver disease, a condition where fat accumulates in the liver without alcohol use. Participants will follow three types of diets: a high-fat/low-carb diet, a low-fat diet, and a Mediterranean diet, each for two weeks. Researchers will monitor the effects using devices that track blood sugar and other body signals, such as a continuous glucose monitor, an integrated sweat sensor, and a vascular sensor. The trial is suitable for U.S. veterans with a waist size over 40 inches for men or 35 inches for women, who also meet specific health criteria like high blood pressure or cholesterol issues. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on dietary impacts on liver health.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you have a thyroid condition, you must be on a stable dose of medication for at least 6 months to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that different diets impact liver health in various ways. The high-fat/low-carb ketogenic diet has mixed results. Some studies suggest it can lower liver fat, which might be beneficial. However, research in mice showed it could also cause liver issues over time, such as fatty liver disease.
While specific data on the low-fat diet isn't provided here, these diets are generally considered safe and are often recommended for heart and liver health.
The Mediterranean diet is recognized for being heart-healthy and is generally considered safe. It emphasizes fruits, vegetables, whole grains, and healthy fats like olive oil, and is often praised for its long-term health benefits.
Overall, these diets are usually well-tolerated. However, everyone is different, and what works for one person might not work for another. Always consult a healthcare provider before making significant dietary changes, especially when considering participation in a clinical trial.12345Why are researchers excited about this trial?
Researchers are excited about these dietary interventions for Non-Alcoholic Fatty Liver Disease (NAFLD) because they offer a fresh approach compared to current standard treatments, which often focus on medications and generalized lifestyle changes. These specific diets—the High-fat/Low-carb diet, Low-fat diet, and Mediterranean diet—are tailored to potentially optimize liver health by modulating metabolism in unique ways. Unlike traditional treatments, these diets incorporate the use of a continuous glucose monitor and sensors to provide real-time insights into how dietary changes affect the body, allowing for a more personalized and precise management of NAFLD. This innovative approach could lead to more effective and individualized treatment strategies, which is why researchers are eager to explore their potential.
What evidence suggests that this trial's dietary interventions could be effective for non-alcoholic fatty liver disease?
Research has shown that different diets can help manage non-alcoholic fatty liver disease (NAFLD). In this trial, participants will follow one of three diets: a high-fat/low-carb diet, a low-fat diet, or a Mediterranean diet. A high-fat/low-carb diet, such as the ketogenic diet, has effectively reduced liver fat and improved liver health. Studies suggest it can reverse fatty liver changes and enhance liver function. Similarly, a low-fat diet has lowered liver enzymes, indicating better liver health. The Mediterranean diet, which includes healthy fats like olive oil, has been linked to reducing the severity of fatty liver. Each of these diets has shown potential benefits for people with NAFLD.16789
Who Is on the Research Team?
Tzung Hsiai, M.D., Ph.D.
Principal Investigator
VAGLAHS and UCLA
Are You a Good Fit for This Trial?
This trial is for individuals with liver conditions like fatty liver and non-alcoholic fatty liver disease. Participants will follow one of three diets: Mediterranean, high-fat/low-carb, or low-fat over a 12-week period while wearing monitoring devices.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants consume their habitual diet for 2 weeks to establish baseline. A continuous glucose monitor (CGM) and integrated sweat and vascular sensors are administered.
Diet Intervention 1
Participants are randomized to one of the three diets (Mediterranean, high-fat/low carb, or low-fat) for 2 weeks. Monitoring includes CGM and integrated sweat and vascular sensors.
Washout
Participants undergo a 2-week washout period between diet interventions.
Diet Intervention 2
Participants switch to a second diet for 2 weeks. Monitoring continues with CGM and integrated sweat and vascular sensors.
Washout
Participants undergo another 2-week washout period between diet interventions.
Diet Intervention 3
Participants switch to the final diet for 2 weeks. Monitoring continues with CGM and integrated sweat and vascular sensors.
Follow-up
Participants are monitored for safety and effectiveness after the diet interventions.
What Are the Treatments Tested in This Trial?
Interventions
- Continuous glucose monitor
- High-fat/Low carb diet
- Low-fat diet
- Mediterranean diet
- The integrated sweat sensor and vascular sensor
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Greater Los Angeles Healthcare System
Lead Sponsor