- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03969199
Give a MANNA a Fish, Teach a MANNA to Fish
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Grace Thiele, BS
- Phone Number: 215-349-5845
- Email: grace.thiele@pennmedicine.upenn.edu
Study Contact Backup
- Name: Vandana Khungar, MD
- Phone Number: 312-316-8415
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MANNA Food Delivery Service
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.
|
Dietary intervention in coordination with MANNA, who will deliver low sodium meals to patients for 90 days
|
No Intervention: Standard of Care Counseling
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustained differential adherence to low sodium diet following intervention
Time Frame: 180 days
|
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.
|
180 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 829424
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Diseases
-
King's College Hospital NHS TrustSamsung MedisonRecruitingHepatitis | Liver Fat | NAFLD | Fibrosis, Liver | Liver Disease Chronic | Liver Steatoses | NASH With FibrosisUnited Kingdom
-
Institute of Liver and Biliary Sciences, IndiaCompletedAcute Liver FailureIndia
-
Beijing Chao Yang HospitalUnknownLiver Transplantation | End Stage Liver DIseaseChina
-
Medical College of WisconsinRecruiting
-
HaEmek Medical Center, IsraelTerminatedPatients With Fatty Liver DiseaseIsrael
-
Beijing Friendship HospitalUnknownNonalcoholic Fatty Liver Disease | Liver Steatosis | Liver FibrosisChina
-
Shiraz University of Medical SciencesCompletedFatty Liver | Fatty Liver, NonalcoholicIran, Islamic Republic of
-
Johannes Gutenberg University MainzUniversity of JenaCompletedNon-alcoholic Fatty Liver Disease | Fatty Liver, NonalcoholicGermany
-
The Cleveland ClinicCompleted
-
Hadassah Medical OrganizationUnknown
Clinical Trials on Intervention
-
Biolux Research Holdings, Inc.TerminatedOrthodontic Tooth MovementCanada
-
University of California, San FranciscoNational Cancer Institute (NCI)CompletedColorectal Carcinoma | Healthy Subject | Health Status UnknownUnited States
-
University of FloridaCompletedSensitivityUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Institute on Minority Health and...RecruitingHuman Papillomavirus InfectionUnited States
-
Ohio State University Comprehensive Cancer CenterCompleted
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnCancer Survivor | Peripheral Sensory Neuropathy
-
Nottingham Trent UniversityUnknownOverweight and ObesityUnited Kingdom
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityRecruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage IIIA Breast Cancer AJCC v8 | Prognostic... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...American Cancer Society, Inc.Completed
-
Vanderbilt UniversityAgency for Healthcare Research and Quality (AHRQ)Completed