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

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.

Conditions

• Heart Failure With Preserved Ejection Fraction

Interventions

BEHAVIORAL

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.

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.

BEHAVIORAL

Exercise + DASH Diet

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

Sponsors & Collaborators

• Grain Foods Foundation

  collaborator UNKNOWN

• University of Virginia

  lead OTHER

Principal Investigators

• Siddhartha S Angadi, PhD · University of Virginia

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-01

Primary Completion

2025-08-01

Completion

2025-08-01

Countries

• United States

Study Locations