High Fiber Diet + High-Intensity Exercise for Heart Failure

Recruiting in Palo Alto (17 mi)

Overseen by Siddhartha S Angadi, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Virginia

Disqualifiers: Unstable angina, Myocardial infarction, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is trying to find out how best to improve common measures of health and survival in those diagnosed with heart failure with preserved ejection fraction (HFpEF) through the implementation of 4 weeks of an exercise training program consisting of high intensity interval training, dietary approaches to stop hypertension (DASH diet), or a combination of the two. Currently there are not established guidelines that have been shown to improve clinical end points in those with this HFpEF.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants must not have medication non-compliance, which suggests that you should continue taking your prescribed medications as directed.

What data supports the effectiveness of the treatment High Fiber Diet + High-Intensity Exercise for Heart Failure?

Research shows that the DASH diet, which is part of this treatment, can lower blood pressure and decrease cardiovascular risk factors, which may help in managing heart failure. ^{1 2 3 4 5}

Is the DASH diet safe for humans?

The DASH diet, which emphasizes fruits, vegetables, lean proteins, and low salt, is generally considered safe for humans and is known to lower blood pressure and improve heart health. ^{1 2 3 6 7}

How is the High Fiber Diet + High-Intensity Exercise treatment for heart failure different from other treatments?

This treatment combines the DASH diet, which is known for reducing blood pressure and improving heart health, with high-intensity interval exercise (HIIT), which can enhance cardiovascular fitness. Unlike traditional heart failure treatments that often focus on medication and dietary restrictions, this approach emphasizes a balanced diet and exercise to address heart health holistically. ^{1 5 6 8 9}

Eligibility Criteria

This trial is for people over 40 with heart failure where the heart pumps normally (HFpEF) and mild to moderate symptoms. They must be cleared by a doctor for exercise and the DASH diet, fully vaccinated against COVID-19, and not have had recent severe heart issues or conditions that prevent them from exercising or following the diet.

Inclusion Criteria

I have moderate to severe heart symptoms.

My doctor has approved me for exercise training.

I am 40 years old or older.

Exclusion Criteria

Pregnant women

You have allergies to nuts or wheat.

You are unable to follow the DASH diet.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 4-week intervention with high-intensity interval exercise, DASH diet, or a combination of both

4 weeks

3 visits per week (in-person for exercise)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dietary Approaches to Stop Hypertension (DASH) Diet (Behavioral Intervention)
• Exercise + DASH Diet (Behavioral Intervention)
• High Intensity Interval Exercise (Behavioral Intervention)

Trial Overview The study tests if high-intensity interval exercise, a healthy eating plan called the DASH diet, or both combined can improve health in those with HFpEF. Participants will follow their assigned programs for four weeks to see which method works best.

Participant Groups

Group I: High Intensity Interval Exercise Experimental Treatment 1 Intervention

Enrolled patients will perform supervised exercise on 3 nonconsecutive days of the week for 4 weeks.

Group II: Exercise + DASH Diet Experimental Treatment 1 Intervention

Enrolled subjects will undergo both the exercise training visits and be provided with the DASH diet.

Group III: Dietary Approaches to Stop Hypertension (DASH) Diet Experimental Treatment 1 Intervention

Enrolled patients will have all of their food prepared for them by a registered dietician for the duration of the study period. The diet will consist of a high fiber content DASH diet.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Virginia University Hospital Charlottesville, VA

Who Is Running the Clinical Trial?

University of Virginia Lead Sponsor

Grain Foods Foundation Collaborator

References

1. Iran pubmed.ncbi.nlm.nih.gov

The Association between DASH Diet Adherence and Cardiovascular Risk Factors. [2023] The dietary approaches to stop hypertension (DASH) encourages high fruit, vegetable, and lean protein consumption and low salt, red meat, and fat intake to prevent or treat hypertension. However, besides hypertension, adherence to this diet has been shown to decrease other cardiovascular risk factors.

2. United States pubmed.ncbi.nlm.nih.gov

Deteriorating dietary habits among adults with hypertension: DASH dietary accordance, NHANES 1988-1994 and 1999-2004. [2016] Although the DASH (Dietary Approaches to Stop Hypertension trial) diet is among the therapeutic lifestyle changes recommended for individuals with hypertension (HTN), accordance with the DASH diet is not known.

3. United States pubmed.ncbi.nlm.nih.gov

Compliance with the Dietary Approaches to Stop Hypertension (DASH) diet: a systematic review. [2023] The Dietary Approaches to Stop Hypertension (DASH) diet has been recognized as effective to lower blood pressure in feeding trials, but compliance with the diet must be persistent to maximize health benefits in clinical practice. This paper reports a systematic review of the latest evidence on the method to assess DASH compliance and the corresponding patients' compliance in interventional settings.

4. United States pubmed.ncbi.nlm.nih.gov

Association between a DASH-like diet and mortality in adults with hypertension: findings from a population-based follow-up study. [2023] Although the Dietary Approaches to Stop Hypertension (DASH) diet lowers blood pressure (BP) in hypertensive adults, its effect on mortality is unclear.

5. United States pubmed.ncbi.nlm.nih.gov

The Dietary Approaches to Stop Hypertension (DASH) Diet Pattern and Incident Heart Failure. [2023] The Dietary Approaches to Stop Hypertension (DASH) diet pattern has shown some promise for preventing heart failure (HF), but studies have been conflicting.

6. United States pubmed.ncbi.nlm.nih.gov

Consistency with the DASH diet and incidence of heart failure. [2021] The Dietary Approaches to Stop Hypertension (DASH) diet effectively reduces blood pressure. In observational studies, the association between diets consistent with DASH and risk of coronary heart disease and stroke has been examined with varying results. We hypothesized that diets consistent with the DASH diet would be associated with a lower incidence of heart failure (HF).

7. England pubmed.ncbi.nlm.nih.gov

Rationale and design of the Optimal Macro-Nutrient Intake Heart Trial to Prevent Heart Disease (OMNI-Heart). [2017] The DASH (Dietary Approaches to Stop Hypertension) diet is a carbohydrate-rich, reduced-fat diet that lowers blood pressure (BP) and LDL-cholesterol. Whether partial replacement of some carbohydrate (C) with either protein (P) or unsaturated fat (U) can further improve these and other cardiovascular (CVD) risk factors is unknown.

8. United States pubmed.ncbi.nlm.nih.gov

A Review of the DASH Diet as an Optimal Dietary Plan for Symptomatic Heart Failure. [2019] Despite tremendous focus, effort, drug and device development and resources dedicated to the care of patients at risk for and with heart failure (HF), the epidemic continues. The HF patient presents with a widely deranged physiology and typically at the same time is malnourished adding to the disease complexity and therapeutic challenges. Most nutritional approaches for patients with HF focus on dietary restrictions (of salt and water) and lack uniformity or clarity or focus on meeting nutritional needs, barriers and deficits of the patient with HF. Finally, it seems reasonable to anticipate that any dietary program recommendation should contribute in a positive way toward HF management goals and at its foundation positively contribute to the deranged physiology. In many ways the "Dietary Approaches to Stop Hypertension" (DASH) dietary program fulfills these needs and early evidence supports the notion that the DASH diet may be optimal for patients with HF. This brief review examines some of this evidence and provides recommendations for the HF community.

9. United States pubmed.ncbi.nlm.nih.gov

Mediterranean and Dietary Approaches to Stop Hypertension dietary patterns and risk of sudden cardiac death in postmenopausal women. [2023] The Mediterranean and Dietary Approaches to Stop Hypertension (DASH) diets are characterized by higher intake of fruit, vegetables, whole grains, and unsaturated fatty acids. All of these foods and nutrients may affect cholesterol, inflammation, the development of atherosclerosis, and, therefore, risk of cardiac death.