Impact of a LCD on Metabolic Inflexibility and Cardiovascular Risk in Liver Transplant Patients

Study Overview
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Brief Summary
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This study is looking to see how a 6-month low carbohydrate diet can affect the body's ability to use energy in addition to the affects it has on the heart and blood vessel health.

Detailed Description
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Weight gain often occurs following a liver transplant. This weight gain is problematic as it leads to many other health problems. The reasons of this weight gain are still poorly understood. To better understand weight gain, this study is looking to see how a 6-month low carbohydrate diet can affect the body's ability to use energy in addition to the affects it has on heart and blood vessel health. This study will help researchers to better understand weight gain after a transplant. This knowledge will help doctors prevent weight gain after a liver transplant and therefore improve the health of liver transplant patients.

Official Title
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Impact of a Low Carbohydrate Diet (LCD) on Metabolic Inflexibility and Cardiovascular Risk in Liver Transplant (LT) Patients

Conditions
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Weight Gain

Intervention / Treatment
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* Behavioral: Control
* Behavioral: LCD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years At least 12 months after LT Obese (BMI > 30kg/m2) Exclusion Criteria: Acute cellular or chronic rejection within 3 months Post-LT liver or non-liver related malignancy Active viral hepatitis (B or C), autoimmune hepatitis Untreated biliary strictures or vascular complications (i.e. hepatic artery thrombosis) Poorly controlled Diabetes mellitus Relapse of alcohol abuse after LT Stage 5 Chronic Kidney Disease Current pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Carbohydrate Diet<br>This arm will be randomized to low carbohydrate diet | Behavioral: LCD<br>* Initial Weight Loss consultation 1.5 hour session on how to do implement healthy diet and then have a 2-week follow-up class. Information on how to maintain a LCD will be provided provided. 4 lifestyle coaching sessions Monthly visits for behavioral and dietary coaching as well as medication management.<br>|
| Active Comparator: Standard Dietary Advice Control Group<br>This arm will be randomized to control diet | Behavioral: Control<br>* Initial Weight Loss consultation 1.5 hour session on how to do implement healthy diet and then have a 2-week follow-up class. Information on how to maintain a healthy combination protein, fat and vegetables daily will be provided provided. 4 lifestyle coaching sessions Monthly visits for behavioral and dietary coaching as well as medication management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Weight will be measured on a standardized scale in kilograms that will be zeroed out prior to the measurement | baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in metabolic flexibility | This will be measured in whole room calorimeter and reported as respiratory quotient | baseline to 6 months | 
| Change in LDL-C | LDL-cholesterol will be measured using a fasting blood draw and a standard lipid panel. | baseline to 6 months | 
| Change in total cholesterol | Total cholesterol will be measured using a fasting blood draw and a standard lipid panel. | baseline to 6 months | 
| Change in small dense low-density lipoprotein | Small dense LDL will be measured using a fasting blood draw and a standard lipid panel. | baseline to 6 months | 
| Change in adiposity | This will be measured on body composition MRI where subcutaneous and visceral fat will be quantified. Subcutaneous fat and visceral fat volume will measured on body composition MRI in liters (L) and standardized to body height and will be reported as liter/m2 | baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Transplant, Low Carbohydrate Diet