Cirrhosis, LiverNCT03969199
Give a MANNA a Fish, Teach a MANNA to Fish
A study testing Intervention in people with Cirrhosis, Liver and Liver Diseases, run by University of Pennsylvania.
Trial summary
This study is a randomized pilot seeking to address low patient adherence to a low sodium diet as a strategy to improve outcomes of patients with cirrhosis of the liver. In coordination with the Metropolitan Area Neighborhood Nutrition Alliance (MANNA) of Philadelphia, patients in the intervention cohort will receive… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cirrhosis, Liver, Liver Diseases, Malnutrition
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Jul 2024
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with cirrhosis of the liver
- 18 to 85 years old
- Ability to read and provide informed consent
- Resides in an area serviced by MANNA
- Has a medical need for restriction of dietary sodium
Who cannot join
- Unclear diagnosis of cirrhosis of the liver
- Inability to provide informed consent
- Any other reason for which the investigator feels the participant would be unable to safely follow the study protocol.
- Resides in an area not serviced by MANNA
- Nutritional needs that cannot be accommodated by MANNA (i.e. vegan or vegetarian, nut-free, gluten-free, Kosher, Macrobiotics and/or allergy to milk, eggs, soybean, peanuts, tree nuts, fish and shellfish.
About this study
This study is a randomized pilot seeking to address low patient adherence to a low sodium diet as a strategy to improve outcomes of patients with cirrhosis of the liver. In coordination with the Metropolitan Area Neighborhood Nutrition Alliance (MANNA) of Philadelphia, patients in the intervention cohort will receive low sodium MANNA meals to encourage improved dietary compliance. Outcomes of these interventional patients will be compared to those receiving standard of care--namely, educational intervention by physicians supplemented by occasional counseling from dieticians during clinic visits encouraging a low sodium diet. Dietary compliance will be evaluated by urine sodium and salt affinity tests and used as a positive marker for improved outcomes. The target population of this study is patients diagnosed with cirrhosis of the liver, aged 18-85 years living within the MANNA-serviced area.
Read the detailed description
Malnutrition causes and complicates numerous chronic illnesses. One in three hospitalized patients in the United States is malnourished, accounting for delayed recovery, increased complications, extended length of stay, and avoidable utilization of healthcare. The projected cost of chronic disease from 2016-2030 in Pennsylvania is $1.7 trillion, with 5% of people accounting for 50 % of healthcare spending.
Patients with cirrhosis of the liver often present with profound malnutrition due to the catabolic effects of their disease. Because of this, adhering to a low sodium diet is of paramount importance in order to avoid fluid overload, a common cause for hospital readmission of patients with cirrhotic decompensations. By maintaining a proper diet, it is possible to mitigate the medical deterioration of patients as well as mitigate the expense of managing chronic illnesses like cirrhosis.
Results from MANNA, a not-for-profit food delivery service, have shown a monthly care cost reduction for patients receiving meals from $41,000 to $28,000, and monthly inpatient cost reduction from $220,000 to $132,000. Results also show that changes in nutritional behavior also improve treatment rates, physical activity, and reduce substance abuse. MANNA has been able to deliver more than 13,000,000 meals to over 20,000 clients since 1990. 99% of patients reported improved overall health after receiving the meals, 92% reported improved emotional health, 98% said it reduced their stress, and 96% said the meals improved their energy. Existing solutions in most health systems are nutritional counseling (either very briefly by a physician, or if patients are fortunate, by a dietician). This is usually not a longitudinal process, and patients are often overwhelmed by medical information.
Despite their remarkable results the acute illness space (6 months of meals), the MANNA service is not scalable to the management of chronic illness; through this study investigators seek to bridge that gap. In coordination with MANNA, investigators will provide 3 months of low sodium MANNA meals to patients in the interventional cohort in an effort to encourage improved adherence to a low sodium diet. Dietary compliance will be assessed using urine sodium and salt affinity tests, and results will be compared between the cohort receiving MANNA meals and the cohort receiving standard of care dietary counseling. Investigators will continue to follow patients for an additional 3 months following the completion of their MANNA service to determine if receiving pre-made low sodium meals for even a short period of time is likely to provide any long-term benefit beyond the span of the study.
- Conditions
- Cirrhosis, Liver, Liver Diseases, Malnutrition
- Being tested
- Intervention
- Keywords
- MANNA, Nutrition, Cirrhosis, Liver, Liver Diseases, Dietary compliance, Low sodium diet, Non-profit, Salt affinity, Behavioral changes
- Medical subject headings
- Liver Cirrhosis, Liver Diseases, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Dietary intervention in coordination with MANNA, who will deliver low sodium meals to patients for 90 days
| Study group | Role | What they receive |
|---|---|---|
| MANNA Food Delivery Service | Experimental | MANNA will deliver meals to patients randomized to the intervention arm of the study every week on the same day for 90 days. Each delivery will include: 7 breakfast meals, 7 lunch meals, 7 dinner entrees, health desserts, and fresh fruit. Meals will be delivered frozen and can be stored in a freezer until ready to eat. Patients will be followed for 180 days and will be assessed for their salt affinity and urine sodium at 3 separate time points throughout the study: baseline, 90 days, and 180 days. Receives: Behavioral: Intervention |
| Standard of Care Counseling | No intervention | Patients randomized to the control arm will receive standard or care dietary counseling from either their physician or a dietician. Patients will be followed for 180 days and will be assessed for their salt affinity and urine sodium at 3 separate time points throughout the study: baseline, 90 days, and 180 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential adherence to a low sodium diet during intervention
A measurable difference in dietary compliance during participation in the MANNA meal program. Compliance will be assessed by performing urine sodium analyses coupled with salt affinity tests following the first 90 days of the study.
Measured: 90 days
Secondary outcomes (1)
Sustained differential adherence to low sodium diet following intervention
A measurable maintained difference in dietary compliance after MANNA meal delivery ceases. Compliance will be assessed by performing urine sodium analyses coupled with salt affinity tests following the final 90 days of the study after MANNA delivery has ended for the intervention arm.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study startDec 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJul 2024 (estimated)
Why it stopped: Study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969199
- Sponsor's protocol ID
- 829424
- Status last verified
- Jan 2024
- First submitted
- 22 May 2019
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Give a MANNA a Fish, Teach a MANNA to Fish
- ClinicalTrials.gov ID
- NCT03969199
- Acronym / sponsor ID
- 829424
- Conditions
- Cirrhosis, Liver, Liver Diseases, Malnutrition
- Keywords
- MANNA, Nutrition, Cirrhosis, Liver, Liver Diseases, Dietary compliance, Low sodium diet, Non-profit, Salt affinity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 31 May 2019 (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.
This study is a randomized pilot seeking to address low patient adherence to a low sodium diet as a strategy to improve outcomes of patients with cirrhosis of the liver. In coordination with the Metropolitan Area Neighborhood Nutrition Alliance (MANNA) of Philadelphia, patients in the intervention cohort will receive low sodium MANNA meals to encourage improved dietary compliance. Outcomes of these interventional patients will be compared to those receiving standard of care--namely, educational intervention by physicians supplemented by occasional counseling from dieticians during clinic visits encouraging a low sodium diet. Dietary compliance will be evaluated by urine sodium and salt affinity tests and used as a positive marker for improved outcomes. The target population of this study is patients diagnosed with cirrhosis of the liver, aged 18-85 years living within the MANNA-serviced area.
Detailed description
Malnutrition causes and complicates numerous chronic illnesses. One in three hospitalized patients in the United States is malnourished, accounting for delayed recovery, increased complications, extended length of stay, and avoidable utilization of healthcare. The projected cost of chronic disease from 2016-2030 in Pennsylvania is $1.7 trillion, with 5% of people accounting for 50 % of healthcare spending.
Patients with cirrhosis of the liver often present with profound malnutrition due to the catabolic effects of their disease. Because of this, adhering to a low sodium diet is of paramount importance in order to avoid fluid overload, a common cause for hospital readmission of patients with cirrhotic decompensations. By maintaining a proper diet, it is possible to mitigate the medical deterioration of patients as well as mitigate the expense of managing chronic illnesses like cirrhosis.
Results from MANNA, a not-for-profit food delivery service, have shown a monthly care cost reduction for patients receiving meals from $41,000 to $28,000, and monthly inpatient cost reduction from $220,000 to $132,000. Results also show that changes in nutritional behavior also improve treatment rates, physical activity, and reduce substance abuse. MANNA has been able to deliver more than 13,000,000 meals to over 20,000 clients since 1990. 99% of patients reported improved overall health after receiving the meals, 92% reported improved emotional health, 98% said it reduced their stress, and 96% said the meals improved their energy. Existing solutions in most health systems are nutritional counseling (either very briefly by a physician, or if patients are fortunate, by a dietician). This is usually not a longitudinal process, and patients are often overwhelmed by medical information.
Despite their remarkable results the acute illness space (6 months of meals), the MANNA service is not scalable to the management of chronic illness; through this study investigators seek to bridge that gap. In coordination with MANNA, investigators will provide 3 months of low sodium MANNA meals to patients in the interventional cohort in an effort to encourage improved adherence to a low sodium diet. Dietary compliance will be assessed using urine sodium and salt affinity tests, and results will be compared between the cohort receiving MANNA meals and the cohort receiving standard of care dietary counseling. Investigators will continue to follow patients for an additional 3 months following the completion of their MANNA service to determine if receiving pre-made low sodium meals for even a short period of time is likely to provide any long-term benefit beyond the span of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MANNA Food Delivery Service | Experimental | Behavioral: InterventionMANNA will deliver meals to patients randomized to the intervention arm of the study every week on the same day for 90 days. Each delivery will include: 7 breakfast meals, 7 lunch meals, 7 dinner entrees, health desserts, and fresh fruit. Meals will be delivered frozen and can be stored in a freezer until ready to eat. Patients will be followed for 180 days and will be assessed for their salt affinity and urine sodium at 3 separate time points throughout the study: baseline, 90 days, and 180 days. |
| Standard of Care Counseling | No intervention | –Patients randomized to the control arm will receive standard or care dietary counseling from either their physician or a dietician. Patients will be followed for 180 days and will be assessed for their salt affinity and urine sodium at 3 separate time points throughout the study: baseline, 90 days, and 180 days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with cirrhosis of the liver
- 18 to 85 years old
- Ability to read and provide informed consent
- Resides in an area serviced by MANNA
- Has a medical need for restriction of dietary sodium
Key exclusion criteria (5 listed)
- Unclear diagnosis of cirrhosis of the liver
- Inability to provide informed consent
- Any other reason for which the investigator feels the participant would be unable to safely follow the study protocol.
- Resides in an area not serviced by MANNA
- Nutritional needs that cannot be accommodated by MANNA (i.e. vegan or vegetarian, nut-free, gluten-free, Kosher, Macrobiotics and/or allergy to milk, eggs, soybean, peanuts, tree nuts, fish and shellfish.
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 |
|---|---|---|
| InterventionDietary intervention in coordination with MANNA, who will deliver low sodium meals to patients for 90 days | Behavioural | MANNA Food Delivery Service |
Primary outcome
Differential adherence to a low sodium diet during intervention
Time frame: 90 days
A measurable difference in dietary compliance during participation in the MANNA meal program. Compliance will be assessed by performing urine sodium analyses coupled with salt affinity tests following the first 90 days of the study.
1 secondary outcome
Sustained differential adherence to low sodium diet following intervention
Time frame: 180 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Cirrhosis, Liver and Liver Diseases, run by University of Pennsylvania.
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Differential adherence to a low sodium diet during intervention (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2024.