Ketogenic Diet vs Mixed Diet in Patients With Heart Failure

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT06081543
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketogenic diet — DIETARY_SUPPLEMENT
    Participants will undertake a controlled feeding intervention. All food will be prepared and delivered to participants by research staff for the first 6 weeks. After that will be a free-living diet period where food will not be supplied but participants will receive educational materials and frequent coaching from a dietitian to help maintain the specified diet. Participants will be asked to exclusively follow the diet in efforts to control any dietary effects.
  • Low-fat Mixed diet — DIETARY_SUPPLEMENT
    Participants will undertake a controlled feeding intervention. All food will be prepared and delivered to participants by research staff for the first 6 weeks. After that will be a free-living diet period where food will not be supplied but participants will receive educational materials and frequent coaching from a dietitian to help maintain the specified diet. Participants will be asked to exclusively follow the diet in efforts to control any dietary effects.

Study Details

This study is being done to evaluate the effects of a low carbohydrate ketogenic diet (KD) versus a low-fat diet (MD) on exercise tolerance in participants with heart failure with normal pumping function and diabetes or pre-diabetes, or metabolic syndrome, or obesity.

Key Dates

Start date
May 19, 2023
Status verified
Mar 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Ketogenic Diet
    This arm will be provided food to induce a state of nutritional ketosis in each person as defined as blood Beta-hydroxybutyrate (3-OHB) ≥0.5 millimoles (mM), which will require most participants to consume \<50 g/day carbohydrate and 1.5g/kg reference weight protein. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods.
  • Experimental: Low-fat mixed Diet
    This arm will be provided food consisting of \~25% fat, and the remaining calories from carbohydrate (\~55% after accounting for protein at \~20%).

Primary Outcome Measure

Changes in maximal exercise performance [ Time Frame: baseline, 6 weeks, and end of the study (26 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ross Heart HospitalColumbusOhio43210
Debbie Scandling, BS
[email protected]
614-688-5623
Alyssa Marie Castillo, MS
[email protected]
614-688-1213
Orlando Simonetti, Ph.D. (SUB_INVESTIGATOR)
Jeff Volek, Ph.D. (SUB_INVESTIGATOR)

Find similar trials in Columbus, OH

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
The Ross Heart Hospital· Columbus, OH

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