ObesityOPTIMISTICNCT05367596
OPTIMIzing muScle Preservation in paTients wIth Cirrhosis
A study testing Continuous Energy Restriction (CER), Alternate Day Modified Fasting (ADMF) and Group Health Education Sessions in people with Obesity and Compensated Cirrhosis, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Patients with obesity and cirrhosis benefit from weight loss but are prone to sarcopenia (loss of muscle mass, strength, and function). 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Compensated Cirrhosis, Sarcopenia
- What is being tested?
- Continuous Energy Restriction (CER), Alternate Day Modified Fasting (ADMF) and Group Health Education Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2022to 16 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects ≥18 years of age. Per the NIH Policy NOT-OD-18-116, we will include adults ≥ 65 yrs.
- 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
Who cannot join
- Child-Pugh (CP) score currently > 6 (i.e., CP Class B/C cirrhosis).
- 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).
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Patients with obesity and cirrhosis benefit from weight loss but are prone to sarcopenia (loss of muscle mass, strength, and function).
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.
Read the detailed description
Patients with both cirrhosis and obesity benefit from weight loss, though patients with cirrhosis are prone to sarcopenia due to accelerated rates of protein turnover, and weight loss typically involves 20-30% of weight loss from lean mass. Prior research indicates that increased intake of high-quality protein, reduced fasting duration, and regular physical activity (particularly resistance training) can improve body composition in patients with cirrhosis. However, weight loss programming specifically tailored to retain lean mass in patients with cirrhosis has not been thoroughly investigated. Further, preliminary data suggests that alternate-day modified fasting, a form of intermittent fasting, may promote lean mass retention during weight loss. Here, this study will compare a weight loss program in patients with both Child-Pugh Class A cirrhosis and obesity using either a standard low-calorie diet (1,200 - 1,500 kcal/day) or alternate day modified fasting featuring a very-low-calorie diet 2-3 days per week for feasibility, satisfaction, and changes in body composition. Both groups will receive a behavioral weight loss program featuring portion-controlled meals and supervised group exercise.
- Conditions
- Obesity, Compensated Cirrhosis, Sarcopenia
- Being tested
- Continuous Energy Restriction (CER), Alternate Day Modified Fasting (ADMF), Group Health Education Sessions, Late Evening Snack, Physical activity
- Medical subject headings
- Obesity, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Energy Restriction (CER)Behavioural
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)Behavioural
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 SessionsBehavioural
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 SnackBehavioural
The participants will have a late evening snack with a protein supplement.
Physical activityBehavioural
All participants will be prescribed moderate-intensity aerobic activities that do not require access to specialized exercise facilities.
Self-monitoringBehavioural
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 SessionsBehavioural
Sessions of 45 minutes duration will be delivered via video conferencing 2-3 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Energy Restriction (CER) | Experimental | 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. Receives: Behavioral: Continuous Energy Restriction (CER); Behavioral: Group Health Education Sessions; Behavioral: Late Evening Snack; Behavioral: Physical activity; Behavioral: Self-monitoring; Behavioral: Remotely Supervised Exercise Sessions |
| Alternate-Day Moderate Fasting (ADMF). | Experimental | Alternate-Day Moderate Fasting (ADMF). Participants in both groups will have a daily late-evening snack and participate in remotely supervised exercises. Receives: Behavioral: Alternate Day Modified Fasting (ADMF); Behavioral: Group Health Education Sessions; Behavioral: Late Evening Snack; Behavioral: Physical activity; Behavioral: Self-monitoring; Behavioral: Remotely Supervised Exercise Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare changes in body composition in both diets
The primary outcome is the percent of weight lost as fat-free mass at 24 weeks. Body weight and body composition (as assessed by dual x-ray absorptiometry) will be measured at baseline, week 12, and post-intervention. Percent weight loss from fat-free mass will be calculated as [Δ fat-free mass / Δ weight loss] for all participants who lose at least 3% of initial body weight. If >70% of participants lose at least 80% of weight from fat mass (or no more than 20% of weight loss coming from lean mass) we will proceed to testing this intervention in an adequately powered trial.
Measured: Baseline, 12 weeks and 24 weeks.
Secondary outcomes (3)
Frailty, Subjective
Karnofsky Performance Status (KPS). The KPS allows patients to be classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the KPS, the worse the survival for most serious illnesses.
Measured: Baseline, 12 weeks and 24 weeks.
Frailty, Objective
The Liver Frailty Index (LFI), composed of 3 performance-based tests (grip strength, chair stands, and balance), is a tool specifically developed in patients with cirrhosis to objectively measure physical function, a critical determinant of health outcomes.
Measured: Baseline, 12 weeks and 24 weeks.
Health Related Quality of Life
Health-related quality of life (HRQOL) is a multi-dimensional concept commonly used to examine the impact of health status on quality of life. HRQOL is often measured by four core questions that asked about general health status and number of unhealthy days.
Measured: Baseline, 12 weeks and 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start22 Jun 2022
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, open-label.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Winston Dunn, M.D., University of Kansas Medical Center
- Investigators
- Winston Dunn, MD, Principal investigator, KUMCFelicia Felicia Steger, PhD, Principal investigator, KUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367596
- Sponsor's protocol ID
- STUDY00148145
- Acronym
- OPTIMISTIC
- Status last verified
- Feb 2023
- First submitted
- 2 May 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39450267
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMIzing muScle Preservation in paTients wIth Cirrhosis
- ClinicalTrials.gov ID
- NCT05367596
- Acronym / sponsor ID
- OPTIMISTIC / STUDY00148145
- Conditions
- Obesity, Compensated Cirrhosis, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with obesity and cirrhosis benefit from weight loss but are prone to sarcopenia (loss of muscle mass, strength, and function).
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.
Detailed description
Patients with both cirrhosis and obesity benefit from weight loss, though patients with cirrhosis are prone to sarcopenia due to accelerated rates of protein turnover, and weight loss typically involves 20-30% of weight loss from lean mass. Prior research indicates that increased intake of high-quality protein, reduced fasting duration, and regular physical activity (particularly resistance training) can improve body composition in patients with cirrhosis. However, weight loss programming specifically tailored to retain lean mass in patients with cirrhosis has not been thoroughly investigated. Further, preliminary data suggests that alternate-day modified fasting, a form of intermittent fasting, may promote lean mass retention during weight loss. Here, this study will compare a weight loss program in patients with both Child-Pugh Class A cirrhosis and obesity using either a standard low-calorie diet (1,200 - 1,500 kcal/day) or alternate day modified fasting featuring a very-low-calorie diet 2-3 days per week for feasibility, satisfaction, and changes in body composition. Both groups will receive a behavioral weight loss program featuring portion-controlled meals and supervised group exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled, open-label.
| Arm | Type | Receives |
|---|---|---|
| Continuous Energy Restriction (CER) | Experimental | Behavioral: Continuous Energy Restriction (CER), Behavioral: Group Health Education Sessions, Behavioral: Late Evening Snack, Behavioral: Physical activity, Behavioral: Self-monitoring, Behavioral: Remotely Supervised Exercise SessionsContinuous 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. |
| Alternate-Day Moderate Fasting (ADMF). | Experimental | Behavioral: Alternate Day Modified Fasting (ADMF), Behavioral: Group Health Education Sessions, Behavioral: Late Evening Snack, Behavioral: Physical activity, Behavioral: Self-monitoring, Behavioral: Remotely Supervised Exercise SessionsAlternate-Day Moderate Fasting (ADMF). Participants in both groups will have a daily late-evening snack and participate in remotely supervised exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects ≥18 years of age. Per the NIH Policy NOT-OD-18-116, we will include adults ≥ 65 yrs.
- 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
Key exclusion criteria (19 listed)
- Child-Pugh (CP) score currently > 6 (i.e., CP Class B/C cirrhosis).
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Continuous Energy Restriction (CER) |
| 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. | Behavioural | Alternate-Day Moderate Fasting (ADMF). |
| Group Health Education SessionsUsing 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. | Behavioural | Alternate-Day Moderate Fasting (ADMF)., Continuous Energy Restriction (CER) |
| Late Evening SnackThe participants will have a late evening snack with a protein supplement. | Behavioural | Alternate-Day Moderate Fasting (ADMF)., Continuous Energy Restriction (CER) |
| Physical activityAll participants will be prescribed moderate-intensity aerobic activities that do not require access to specialized exercise facilities. | Behavioural | Alternate-Day Moderate Fasting (ADMF)., Continuous Energy Restriction (CER) |
| Self-monitoringWeekly 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. | Behavioural | Alternate-Day Moderate Fasting (ADMF)., Continuous Energy Restriction (CER) |
| Remotely Supervised Exercise SessionsSessions of 45 minutes duration will be delivered via video conferencing 2-3 times per week. | Behavioural | Alternate-Day Moderate Fasting (ADMF)., Continuous Energy Restriction (CER) |
Primary outcome
Compare changes in body composition in both diets
Time frame: Baseline, 12 weeks and 24 weeks.
The primary outcome is the percent of weight lost as fat-free mass at 24 weeks. Body weight and body composition (as assessed by dual x-ray absorptiometry) will be measured at baseline, week 12, and post-intervention. Percent weight loss from fat-free mass will be calculated as [Δ fat-free mass / Δ weight loss] for all participants who lose at least 3% of initial body weight. If >70% of participants lose at least 80% of weight from fat mass (or no more than 20% of weight loss coming from lean mass) we will proceed to testing this intervention in an adequately powered trial.
3 secondary outcomes
Frailty, Subjective
Time frame: Baseline, 12 weeks and 24 weeks.
Frailty, Objective
Time frame: Baseline, 12 weeks and 24 weeks.
Health Related Quality of Life
Time frame: Baseline, 12 weeks and 24 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Derived from this study: PubMed 39450267Dunn 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winston Dunn, MD principal investigator
KUMC
Felicia Felicia Steger, PhD principal investigator
KUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Energy Restriction (CER), Alternate Day Modified Fasting (ADMF) and Group Health Education Sessions in people with Obesity and Compensated Cirrhosis, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare changes in body composition in both diets (time frame: Baseline, 12 weeks and 24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05367596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.