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}

Research Team

Siddhartha S Angadi, PhD

Principal Investigator

University of Virginia

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.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

James E. Ryan

University of Virginia

Chief Executive Officer since 2018

J.D. from Harvard Law School

Nikki Hastings

University of Virginia

Chief Medical Officer since 2018

Ph.D. in Biomedical Engineering from University of Virginia

Grain Foods Foundation

Collaborator

Trials

2

Recruited

160+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

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

The Association between DASH Diet Adherence and Cardiovascular Risk Factors. [2023]

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]

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

Compliance with the Dietary Approaches to Stop Hypertension (DASH) diet: a systematic review. [2023]

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]

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

The Dietary Approaches to Stop Hypertension (DASH) Diet Pattern and Incident Heart Failure. [2023]

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

Consistency with the DASH diet and incidence of heart failure. [2021]

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]

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

A Review of the DASH Diet as an Optimal Dietary Plan for Symptomatic Heart Failure. [2019]

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]