The Effect of a High Fiber Diet and High-Intensity Interval Exercise in Patients With HFpEF

NCT ID: NCT05236413

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-08-01

Brief Summary

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.

Detailed Description

In the face of a rapidly growing population of older, HFpEF patients, there remains a need to identify ideal rehabilitative therapies to enhance improvements in the physical function of these patients. Pharmacological trials in this population have been characterized by a failure to significantly improve exercise tolerance and hard clinical outcomes and this is likely due to their singular cardiovascular focus. Exercise appears to be a promising intervention to improve cardiorespiratory fitness and reduce cardiovascular risk. Further, evidence-based dietary guidelines for patients with heart failure are lacking. Although a high-protein, low-carbohydrate diet is associated with improvements in traditional CV risk markers in patients with heart failure, it may raise cardiovascular risk in this population by adversely affecting endothelial function, increasing susceptibility to myocardial ischemia, and by inducing a pro-inflammatory state due to increased bacterial and LPS translocation through the ischemic gut. Thus, the investigators will explore the effects of the high-carbohydrate, high-fiber DASH diet due to its potential to have salutary effects on vascular risk in this population. In this study, the investigators will examine the singular and combined effects of exercise and a DASH diet in patients with HFpEF on markers of cardiovascular risk.

Conditions

Heart Failure With Preserved Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

High Intensity Interval Exercise

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

Group Type: EXPERIMENTAL

High Intensity Interval Exercise

Intervention Type: BEHAVIORAL

Patients will be required to report for three sessions of supervised stationary cycling exercise per week over a period of 4-weeks. Training heart rates will be determined based on the pre-testing VO2peak and peak heart rate (PHR). All sessions will be supervised by trained personnel.

Patients will start with eight intervals of 2-min duration at 80-85% of PHR, separated by 2 min of recovery at 50% of PHR, progressing to four, 4-min intervals at 90-95% PHR, separated by 3 min at 50% PHR by the end of week 2.

Each training session will begin with a 10-min warm-up at 50% of PHR and end with a 5-min cool down at 50% PHR. Subjects will be weighed prior to every exercise session and weight tracked to ensure that their volume status hasn't changed significantly. Subjects will be instructed to maintain usual levels of physical activity and usual diet during the study and not to make any modifications to the same.

Dietary Approaches to Stop Hypertension (DASH) Diet

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.

Group Type: EXPERIMENTAL

Dietary Approaches to Stop Hypertension (DASH) Diet

Intervention Type: BEHAVIORAL

Patients will be interviewed with regard to their food/religious preferences and food allergies and a 7-day rotating meal plan will be designed per their preferences along with a registered dietitian. This will ensure that patients receive food that is acceptable to them. Participants will then be provided pre-packaged meals for 4-weeks with macronutrient compositions as follows - (Carbohydrates -55-60%, Protein -15-20%, Fat -15-25%, Fiber -35-45g/day). All foods will be labeled, sealed, and packed for weekly delivery and will be designed such that they can be refrigerated or frozen and stored without significant alterations to nutritional content. All food will be prepared by the UVA Hospital Nutrition Services department in conjunction with a registered dietician. Deviations (if any) from the study meal plan will be recorded by the participants in a food record provided at the start of each diet intervention period.

Exercise + DASH Diet

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

Group Type: EXPERIMENTAL

Exercise + DASH Diet

Intervention Type: BEHAVIORAL

Patients will undergo both the exercise training intervention and DASH diet as explained above.

Interventions

High Intensity Interval Exercise

Patients will be required to report for three sessions of supervised stationary cycling exercise per week over a period of 4-weeks. Training heart rates will be determined based on the pre-testing VO2peak and peak heart rate (PHR). All sessions will be supervised by trained personnel.

Patients will start with eight intervals of 2-min duration at 80-85% of PHR, separated by 2 min of recovery at 50% of PHR, progressing to four, 4-min intervals at 90-95% PHR, separated by 3 min at 50% PHR by the end of week 2.

Each training session will begin with a 10-min warm-up at 50% of PHR and end with a 5-min cool down at 50% PHR. Subjects will be weighed prior to every exercise session and weight tracked to ensure that their volume status hasn't changed significantly. Subjects will be instructed to maintain usual levels of physical activity and usual diet during the study and not to make any modifications to the same.

Intervention Type: BEHAVIORAL

Dietary Approaches to Stop Hypertension (DASH) Diet

Patients will be interviewed with regard to their food/religious preferences and food allergies and a 7-day rotating meal plan will be designed per their preferences along with a registered dietitian. This will ensure that patients receive food that is acceptable to them. Participants will then be provided pre-packaged meals for 4-weeks with macronutrient compositions as follows - (Carbohydrates -55-60%, Protein -15-20%, Fat -15-25%, Fiber -35-45g/day). All foods will be labeled, sealed, and packed for weekly delivery and will be designed such that they can be refrigerated or frozen and stored without significant alterations to nutritional content. All food will be prepared by the UVA Hospital Nutrition Services department in conjunction with a registered dietician. Deviations (if any) from the study meal plan will be recorded by the participants in a food record provided at the start of each diet intervention period.

Intervention Type: BEHAVIORAL

Exercise + DASH Diet

Patients will undergo both the exercise training intervention and DASH diet as explained above.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ≥40 years of age
• Diagnosed with heart failure with preserved ejection fraction
• NYHA class II-III symptoms
• Physician clearance to undergo exercise training
• Physician clearance to consume DASH diet
• Complete COVID-19 vaccination status

Exclusion Criteria

• Unstable angina
• Myocardial infarction in the past 4 weeks
• Uncompensated heart failure
• NYHA class IV symptoms
• Complex ventricular arrhythmias
• Musculoskeletal contraindications to stationary bicycling exercise
• Symptomatic severe aortic stenosis
• Acute pulmonary embolus
• Acute myocarditis
• Uncontrolled hypertension
• Medication non-compliance
• Unable to follow DASH diet
• Food allergies (Nuts, wheat)
• Pregnant women

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grain Foods Foundation

UNKNOWN

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Siddartha Angadi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Siddhartha S Angadi, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia University Hospital

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Siddhartha S Angadi, PhD

Role: CONTACT

ssa2w@virginia.edu

434-243-7466

Nathan Weeldreyer, MS

Role: CONTACT

nw8ky@virginia.edu

434-243-8677

Facility Contacts

Siddhartha S Angadi, PhD

Role: primary

ssa2w@virginia.edu

Nathan Weeldreyer, MS

Role: backup

nw8ky@virginia.edu

434-243-8677

Other Identifiers

HSR210393

Identifier Type: -

Identifier Source: org_study_id