Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04847973 · ClinicalTrials.gov registry record · NA
Food As Medicine for Heart Failure
A NA study, sponsored by Tufts Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT04847973 is a NA study that has completed, run by Tufts Medical Center. The registered enrollment target is 6 participants.
The verdict
NCT04847973, a NA study, has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study Summary
Malnutrition and unintentional weight loss are highly prevalent among patients with heart failure (HF), with approximately 50% of patients with heart failure meeting malnutrition criteria. Poor dietary quality and micronutrient deficiencies are associated with higher rates of HF hospitalization and mortality. Therefore nutritional interventions to improve dietary quality and prevent malnutrition development may represent an effective strategy to improve HF-related health status and survival outcomes. To date, there are no large clinical trials investigating the efficacy of 'food as medicine' to improve morbidity and mortality for patients with heart failure with reduced ejection fraction (HFrEF). The investigators plan to conduct a single-center, randomized pilot trial to assess the tolerability, feasibility, and efficacy of providing medically-tailored meals (MTMs) or protein supplementation shakes to patients with HFrEF and malnutrition. The investigators hypothesize that home delivery of MTMs or protein supplementation shakes will be feasible, well-tolerated and achieve a high degree of satisfaction for patients with HFrEF. The current pilot phase is a single arm non-randomized study. An initial phase has delivered a 12-week MTM dietary intervention. The MTMs are designed, prepared and delivered by our community based organized partner, Community Servings. A second phase will deliver a 12-week protein supplementation shake intervention, with 1 bottle to be consumed daily in addition to the participants' standard home diet. The investigators will measure HF-related health status, functional capacity, and biomarkers of heart failure and nutritional status before and after each study phase. The proposed study will facilitate a larger future randomized trial of nutritional intervention for patients with HFrEF and malnutrition, powered to examine the impact on HF hospitalizations and mortality.
Interventions
- OTHER Medically-Tailored Meals (MTMs)
- DIETARY_SUPPLEMENT Protein supplementation shakes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-04-16 |
| Est. Completion | 2023-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04847973
The ClinicalTrials.gov registry entry for NCT04847973 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts Medical Center, which has 169 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Medically-Tailored Meals (MTMs) is the first listed.
NCT04847973 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04847973 about?
NCT04847973 is a clinical study titled "Food As Medicine for Heart Failure". Malnutrition and unintentional weight loss are highly prevalent among patients with heart failure (HF), with approximately 50% of patients with heart failure meeting malnutrition criteria. Poor dietary quality and micronutrient deficiencies are associated with higher rates of HF hospitalization and ...
What is the current status of trial NCT04847973?
This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2021-04-16. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT04847973?
The interventions under investigation include: Medically-Tailored Meals (MTMs) (OTHER), Protein supplementation shakes (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04847973?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.