Recruiting

High Fiber Diet & HIIT

Sponsor:

University of Virginia

Code:

NCT05236413

Conditions

Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

High Intensity Interval Exercise

Dietary Approaches to Stop Hypertension (DASH) Diet

Exercise + DASH Diet

Study Details

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Study ID

NCT05236413

Start date

Apr 1, 2022

Status verified date

May, 2024

Completion date

Aug 1, 2025

Anticipated

Primary completion date

Aug 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: High Intensity Interval Exercise

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

experimental: 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.

experimental: Exercise + DASH Diet

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

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.

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.

Exercise + DASH Diet

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

Primary outcome measure

  • VO2peak [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Siddhartha S Angadi, PhD

434-243-7466ssa2w@virginia.edu

Nathan Weeldreyer, MS

434-243-8677nw8ky@virginia.edu

Locations

University of Virginia University Hospital

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Siddhartha S Angadi, PhD

ssa2w@virginia.edu

Nathan Weeldreyer, MS

434-243-8677nw8ky@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

May 7, 2024

Last verified

May, 2024

Keywords

  • HIIT
  • DASH
  • High Fiber
  • HFpEF
  • heart failure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2024-05-07.