An interventional study of Medically-Tailored Meals (MTMs) and Protein supplementation shakes in Heart Failure and Malnutrition, sponsored by Tufts Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by Tufts Medical Center · Not applicable, Interventional, and Treatment
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.
We plan to conduct a single-center pilot trial to assess the tolerability, feasibility, and efficacy of providing medically-tailored meals to patients with heart failure with reduced ejection fraction and malnutrition. We hypothesize that a nutritionally complete meal plan, targeting 1.1-1.5 g/kg/day protein intake, will improve symptomatology, functional capacity, and serum biomarkers of heart failure in this patient population. We have two primary objectives for this pilot study: 1) confirm tolerability, feasibility, and efficacy of prescribing MTMs or oral protein supplementation and 2) measure changes in functional capacity, patient-reported health status, and biomarkers of nutritional status and heart failure over the course of the study period. For this proposed study, we will test the following elements of this central hypothesis with 2 aims:
Aim 1 Tolerability, feasibility, and efficacy of prescribing medically-tailored meals or protein supplementation: Tolerability will be assessed with the validated 28-item dietary satisfaction score (DSat-28). Efficacy will be assessed by improvement in patient-reported health status questionnaires and feasibility will be assessed by the macronutrient intakes achieved on facilitated food recalls.
Aim 2 Functional capacity and serum biomarkers of nutrition/heart failure: Determine whether medically tailored meals improve symptomatology, functional capacity, and serum biomarkers of nutrition and heart failure in patients with advanced heart failure.
5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's enrollment of 6 is below the median of 72 across 3,733 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Tufts Medical Center is the lead sponsor of 194 studies on the registry; 28 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 16 (53%) have results posted.
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Exclusion Criteria:
12 weeks of home-delivered medically-tailored meals (MTMs), prepared and delivered by the non-profit Community Servings. The MTM has be developed specifically for patients with heart failure, with an approximate protein intake range of 1.1-1.5 g/kg body weight/day and a maximum of 2000 mg sodium/day.
Other: Medically-Tailored Meals (MTMs)
Participants will receive 1 bottle of Ensure Max Protein shake every day (any flavor option without caffeine, daily for 12 weeks) to take in addition to their standard diet, without MTM delivery.
Dietary Supplement: Protein supplementation shakes
12 weeks of home-delivered MTMs, delivered weekly, containing food for 3 meals per day on 5 days of the week
12 weeks of 1 bottle of Ensure Max Protein shake every day, in addition to partcipants' standard diet
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Patient reported health measure (scale 0 to 100, higher indicates better health status)
Time frame: Change from start to end of 12-week MTM period
Handgrip strength measurement in kg
Upper extremity strength measured by dynamometer (higher kg achieved indicates greater strength)
Time frame: Change from start to end of 12-week MTM period
Sit-to-stand test
Lower extremity strength measure (lower time indicates greater strength)
Time frame: Change from start to end of 12-week MTM period
6 minute walk test
Strength and endurance measure
Time frame: Change from start to end of 12-week MTM period
Diet Satisfaction scale (DSat-28)
Dietary satisfaction measure
Time frame: Change from start to end of 12-week MTM period
Short Nutritional Assessment Questionnaire (SNAQ)
Appetite questionnaire (score ranges 0 to 7, \>/=3 indicating a severe malnutrition risk)
Time frame: Change from start to end of 12-week MTM period
Facilitated food recall
3-day 24-hour facilitated food recall
Time frame: Change from start to end of 12-week MTM period
Weight
Subject's body weight, measured on standing scale
Time frame: Change from start to end of 12-week MTM period
Plan to share: No
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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