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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: Completed NA study, sponsored by Tufts Medical Center.
NCT04847973 is a NA study that has completed, run by Tufts Medical Center. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Patient reported health measure (scale 0 to 100, higher indicates better health status)
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 |
What the finished NCT04847973 record still lists
NCT04847973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Medically-Tailored Meals (MTMs) is the first listed.
NCT04847973 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04847973's enrollment target sits among peer trials
6 1983rd of 2000 higher than 13 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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