High Fiber Diet + High-Intensity Exercise for Heart Failure

Overseen By Nathan Weeldreyer, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Unstable angina, Myocardial infarction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests methods to improve health and survival in people with heart failure with preserved ejection fraction (HFpEF), a condition where the heart can't properly fill with blood. It examines three approaches: a high-fiber DASH diet (Dietary Approaches to Stop Hypertension), high-intensity exercise, or a combination of both. Participants should have HFpEF and experience symptoms like shortness of breath or fatigue during regular activities. As an unphased trial, this study provides a unique opportunity to explore innovative lifestyle changes that could enhance quality of life.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Dietary Approaches to Stop Hypertension (DASH) diet is generally easy for most people to follow. Most studies report few negative effects, although information on its long-term safety remains limited. The diet is linked to a lower risk of heart failure and other heart problems, emphasizing fruits, vegetables, and whole grains, which are typically safe for most individuals.

High-intensity interval training (HIIT) has proven safe and effective for people with heart issues. Research indicates that HIIT improves heart health and fitness levels without causing more negative effects than moderate exercise, making it a suitable option for many patients.

Both the DASH diet and HIIT have been studied separately for heart health, showing positive results. When combined, as in this study, they might offer even more benefits. However, the long-term safety of using both together has not been extensively studied. Overall, both treatments are considered safe for most people, but consulting healthcare providers before starting any new diet or exercise program is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for heart failure because they integrate lifestyle changes that target the condition in innovative ways. Unlike the standard of care, which often involves medication, the Dietary Approaches to Stop Hypertension (DASH) diet and High-Intensity Interval Exercise offer non-pharmacological approaches. The DASH diet focuses on a high-fiber nutritional plan meticulously prepared by dietitians, which has the potential to improve heart health naturally. High-Intensity Interval Exercise introduces a structured, supervised exercise regimen that could enhance cardiovascular function more effectively than traditional exercise routines. Combining exercise with the DASH diet further amplifies these benefits, potentially leading to more significant improvements in heart failure management.

What evidence suggests that this trial's treatments could be effective for heart failure?

Research has shown that the DASH diet, one of the treatments in this trial, can significantly reduce the risk of heart failure and lower markers of heart stress, such as cardiac troponin I, over time. High-intensity interval training (HIIT), another treatment option in this trial, enhances heart function and improves survival rates by increasing the efficiency of the heart's left side. It also boosts overall fitness and heart health. This trial will also test the combination of the DASH diet with exercise, potentially offering additional benefits by addressing both diet and physical activity together. ^{2 3 4 6 7}

Who Is on the Research Team?

Siddhartha S Angadi, PhD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Grain Foods Foundation

Collaborator

Trials

2

Recruited

160+

Published Research Related to This Trial

Adherence to the DASH diet is linked to a lower risk of developing heart failure (HF) in a diverse population of adults aged 45 and older, with significant reductions in risk observed in those under 75 years old.

The study analyzed data from the REGARDS cohort, finding that individuals in higher DASH diet score quartiles had a reduced hazard ratio for incident HF, indicating that a healthier diet may help prevent heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dietary Approaches to Stop Hypertension (DASH) Diet Pattern and Incident Heart Failure. Goyal, P., Balkan, L., Ringel, JB., et al.[2023]

Heart failure (HF) patients often face complex challenges due to deranged physiology and malnutrition, making effective nutritional strategies crucial for their care.

The DASH (Dietary Approaches to Stop Hypertension) diet may be particularly beneficial for HF patients, as it aligns with the need for a dietary program that supports both nutritional needs and HF management goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of the DASH Diet as an Optimal Dietary Plan for Symptomatic Heart Failure. Rifai, L., Silver, MA.[2019]

In a study of 36,019 women aged 48 to 83, those who closely followed the DASH diet had a 37% lower rate of heart failure (HF) over 7 years compared to those who did not, even after adjusting for various health and lifestyle factors.

The results suggest that adherence to the DASH diet is linked to a significant reduction in the risk of heart failure, indicating its potential as a preventive dietary approach for heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consistency with the DASH diet and incidence of heart failure. Levitan, EB., Wolk, A., Mittleman, MA.[2021]

In a study of 93,122 postmenopausal women followed for an average of 10.5 years, a higher adherence to the Mediterranean diet was linked to a significantly lower risk of sudden cardiac death (SCD), with a hazard ratio of 0.64 for those in the highest quintile compared to the lowest.

The DASH diet did not show a significant association with SCD risk, possibly due to inadequate characterization of sodium intake, which is a key component of the DASH dietary pattern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean and Dietary Approaches to Stop Hypertension dietary patterns and risk of sudden cardiac death in postmenopausal women. Bertoia, ML., Triche, EW., Michaud, DS., et al.[2023]

In a study of 4386 adults with hypertension, only 19.4% adhered to the DASH diet, indicating low compliance with this recommended dietary approach.

Compared to earlier data from 1988-1994, adherence to the DASH diet has decreased significantly by 7.3%, suggesting a decline in dietary quality among individuals with hypertension over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deteriorating dietary habits among adults with hypertension: DASH dietary accordance, NHANES 1988-1994 and 1999-2004. Mellen, PB., Gao, SK., Vitolins, MZ., et al.[2016]

In a study of 5,532 hypertensive adults, those who followed a DASH-like diet had a 31% lower risk of all-cause mortality compared to those who did not, indicating the diet's potential effectiveness in improving longevity.

The DASH-like diet was particularly associated with a significant reduction in stroke mortality (89% lower risk), although its effects on cardiovascular disease and cancer mortality were not statistically significant.

NCBI (Pubmed)

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. Parikh, A., Lipsitz, SR., Natarajan, S.[2023]

A study of 2,831 adults in Iran found that adherence to the DASH diet is associated with lower levels of cardiovascular risk factors, including blood pressure, fasting blood sugar, triglycerides, and cholesterol.

Specifically, individuals in the highest quintile of DASH diet adherence had a 28% lower odds of hyperglycemia, suggesting that the DASH diet may be effective in reducing the risk of diabetes and other cardiovascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association between DASH Diet Adherence and Cardiovascular Risk Factors. Shoaibinobarian, N., Danehchin, L., Mozafarinia, M., et al.[2023]

The DASH diet is effective in lowering blood pressure, but studies show that compliance with the diet is often suboptimal, especially in educational interventions compared to controlled feeding trials.

There is no consensus on the best method to assess compliance with the DASH diet, highlighting the need for more effective strategies to maintain adherence beyond just dietary counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with the Dietary Approaches to Stop Hypertension (DASH) diet: a systematic review. Kwan, MW., Wong, MC., Wang, HH., et al.[2023]

The OmniHeart study is a randomized crossover trial involving 160 adults with prehypertension or Stage 1 hypertension, designed to compare the effects of a carbohydrate-rich diet with diets high in protein or unsaturated fat on blood pressure and cholesterol levels.

The study aims to provide insights into how different macronutrient compositions can influence cardiovascular risk factors, potentially guiding dietary recommendations for better heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of the Optimal Macro-Nutrient Intake Heart Trial to Prevent Heart Disease (OMNI-Heart). Carey, VJ., Bishop, L., Charleston, J., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6527445/

Dietary Approaches to Stop Hypertension Diet Concordance ... High concordance to a DASH diet, as indicated by the quintile score, was associated with a lower risk of developing HF in MESA participants under age 75 years.

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.026684

Effects of the Dietary Approaches to Stop Hypertension ... In comparison with a typical American diet, the DASH diet reduced high‐sensitivity cardiac troponin I and hs‐CRP progressively over 12 weeks.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40326569/

Dietary Approaches to Stop Hypertension (DASH) for the ... Authors' conclusions: The effect of the DASH diet on major cardiovascular outcomes - including myocardial infarction, stroke, cardiovascular ...

4. academic.oup.com academic.oup.com/eurjpc/article/29/7/1114/6496949

DASH diet is associated with a lower risk of heart failure Replacing 1 serving/day of red and processed meat with emphasized DASH diet foods was associated with an 8–12% lower risk of HF. Conclusion.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00939640

Effects of the Dietary Approaches to Stop Hypertension ... The investigators hypothesize that the DASH/SRD will have favorable effects on oxidative stress, ventricular and vascular function, and blood pressure control ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8396128/

The Dietary Approaches to Stop Hypertension (DASH) Diet ... Compared to the lowest quartile, individuals in the 2nd-4th DASH diet score quartiles had lower risk for incident HF after adjustment for sociodemographic and ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899900713000075

Effects of Dietary Approaches to Stop Hypertension (DASH ... Our results showed that a DASH-like diet can significantly protect against CVDs, CHD, stroke, and HF risk by 20%, 21%, 19% and 29%, respectively.