OPTIMIzing muScle Preservation in paTients wIth Cirrhosis
NCT ID: NCT05367596
Last Updated: 2023-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2022-06-22
2022-12-16
Brief Summary
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This study proposes to test a specialized weight loss program Alternative-day Modified Fasting (ADMF) designed to promote weight loss and preserve skeletal muscle mass, strength, and function in patients with both Child-Pugh (CP) class A cirrhosis and obesity. This study will compare the effectiveness of the ADMF to Continuous Energy Restriction (CER) for 24-weeks. Both arms will receive a high-protein, high-BCAA diet, a late-night snack, supervised aerobic and resistance exercise, increased physical activity through self-monitoring, and group behavioral counseling.
The primary aim of this trial is to evaluate the feasibility and acceptability of ADMF and CER for 6 months in patients with cirrhosis and obesity. The secondary aim is to compare changes in body composition in both diets.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Continuous Energy Restriction (CER)
Continuous energy restriction (CER; 1,200-1,500 kcal/day). Participants in both groups will have a daily late-evening snack and participate in remotely supervised exercises.
Continuous Energy Restriction (CER)
Energy intake will be prescribed at approximately 1,200-1,500 kcal/day with high protein. The diet will consist of low-calorie shakes provided by the study, as well as commercially available portion-controlled entrées, fruits/vegetables, and low energy-density foods available in grocery stores.
Group Health Education Sessions
Using video conferencing, all participants will attend weekly approximately 45-60 minutes group health education sessions led by a registered dietitian. The session will deliver a comprehensive nutritional and lifestyle change program to promote lifestyle changes and improve compliance.
Late Evening Snack
The participants will have a late evening snack with a protein supplement.
Physical activity
All participants will be prescribed moderate-intensity aerobic activities that do not require access to specialized exercise facilities.
Self-monitoring
Weekly data related to adherence, food intake, physical activity, weight measurement, and nonserious adverse events will be self-reported via a REDCap survey. Participants will also be provided with a wireless activity tracker to measure total physical activity and intensity of activity objectively. These data will be used to counsel participants in addition to providing valuable feasibility data.
Remotely Supervised Exercise Sessions
Sessions of 45 minutes duration will be delivered via video conferencing 2-3 times per week.
Alternate-Day Moderate Fasting (ADMF).
Alternate-Day Moderate Fasting (ADMF). Participants in both groups will have a daily late-evening snack and participate in remotely supervised exercises.
Alternate Day Modified Fasting (ADMF)
Enhanced Care participants will have an alternate between three days of very-low energy intake (VLED; approximately 600-800 kcal/d) and four days of healthy eating (HE) each week. On HE days, participants will consume foods ad libitum for satiety.
Group Health Education Sessions
Using video conferencing, all participants will attend weekly approximately 45-60 minutes group health education sessions led by a registered dietitian. The session will deliver a comprehensive nutritional and lifestyle change program to promote lifestyle changes and improve compliance.
Late Evening Snack
The participants will have a late evening snack with a protein supplement.
Physical activity
All participants will be prescribed moderate-intensity aerobic activities that do not require access to specialized exercise facilities.
Self-monitoring
Weekly data related to adherence, food intake, physical activity, weight measurement, and nonserious adverse events will be self-reported via a REDCap survey. Participants will also be provided with a wireless activity tracker to measure total physical activity and intensity of activity objectively. These data will be used to counsel participants in addition to providing valuable feasibility data.
Remotely Supervised Exercise Sessions
Sessions of 45 minutes duration will be delivered via video conferencing 2-3 times per week.
Interventions
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Continuous Energy Restriction (CER)
Energy intake will be prescribed at approximately 1,200-1,500 kcal/day with high protein. The diet will consist of low-calorie shakes provided by the study, as well as commercially available portion-controlled entrées, fruits/vegetables, and low energy-density foods available in grocery stores.
Alternate Day Modified Fasting (ADMF)
Enhanced Care participants will have an alternate between three days of very-low energy intake (VLED; approximately 600-800 kcal/d) and four days of healthy eating (HE) each week. On HE days, participants will consume foods ad libitum for satiety.
Group Health Education Sessions
Using video conferencing, all participants will attend weekly approximately 45-60 minutes group health education sessions led by a registered dietitian. The session will deliver a comprehensive nutritional and lifestyle change program to promote lifestyle changes and improve compliance.
Late Evening Snack
The participants will have a late evening snack with a protein supplement.
Physical activity
All participants will be prescribed moderate-intensity aerobic activities that do not require access to specialized exercise facilities.
Self-monitoring
Weekly data related to adherence, food intake, physical activity, weight measurement, and nonserious adverse events will be self-reported via a REDCap survey. Participants will also be provided with a wireless activity tracker to measure total physical activity and intensity of activity objectively. These data will be used to counsel participants in addition to providing valuable feasibility data.
Remotely Supervised Exercise Sessions
Sessions of 45 minutes duration will be delivered via video conferencing 2-3 times per week.
Eligibility Criteria
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Inclusion Criteria
* Subjects have a BMI of 30-45. Body mass index (BMI) of 25 to 45 kg/m2. Individuals with a BMI\< 25 kg/m2 are not overweight, and individuals with a BMI \>45 kg/m2 require more aggressive weight-loss interventions such as bariatric surgery.
* Subjects has a diagnosis of cirrhosis based on any of the following methods
* Liver Biopsy is consistent with stage IV fibrosis according to the NASH Clinical Research Network (CRN) scoring system.
* Fibroscan Liver Stiffness \>14kpa
* Endoscopy or imaging finding of varices
Exclusion Criteria
* History of ascites.
* History of portal system encephalopathy.
* Prior history of liver cancer.
* Prior history of non-melanoma skin cancer within the last five years
* Hepatitis C Virus (HCV) patients who have not undergone sustained virological response (SVR).
* Hepatitis B Virus (HBV) Patients who have not received antiviral treatment.
* Patients with diabetes currently on insulin and or sulfonylureas.
* Active alcohol use \>7 drinks per week in the past six months.
* Suspected eating disorders based on Eating Attitudes Test (EAT-26) and The Binge Eating Scale (BES):
* Unable to participate in moderate-intensity PA, e.g., brisk walking
* Participation in a structured weight loss program in the previous six mos.
* Not weight stable (5%) for three months prior to intake.
* Unwilling to be randomized.
* Pregnancy during the previous six mos., currently lactating, or planned pregnancy in the following six mos
* Current use of antipsychotics, untreated depression, or other psychiatric illnesses would preclude weight management participation.
* Adherence to specialized diets that would make it difficult or impossible to follow the guidelines for intervention.
* Evidence of eating disorder or binge eating (as assessed by the Eating Attitudes Test and or Binge Eating Scale.)
* Do not have access to a wireless equipment necessary for remotely delivered group and exercise classes.
18 Years
ALL
No
Sponsors
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University of Kansas Medical Center
OTHER
Responsible Party
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Winston Dunn, M.D.
Associate Professor
Principal Investigators
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Winston Dunn, MD
Role: PRINCIPAL_INVESTIGATOR
KUMC
Felicia Felicia Steger, PhD
Role: PRINCIPAL_INVESTIGATOR
KUMC
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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References
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Dunn W, Herrmann SD, Montgomery RN, Hastert M, Honas JJ, Rachman J, Donnelly JE, Steger FL. Optimizing muscle preservation during weight loss in patients with cirrhosis: A pilot study comparing continuous energy restriction to alternate-day modified fasting for weight loss in patients with obesity and non-alcoholic cirrhosis of the liver. Obes Sci Pract. 2024 Oct 24;10(5):e70016. doi: 10.1002/osp4.70016. eCollection 2024 Oct.
Other Identifiers
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STUDY00148145
Identifier Type: -
Identifier Source: org_study_id
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