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Behavioural Intervention

Ketogenic Diet vs Mixed Diet for Heart Failure

N/A
Recruiting
Led By Yuchi Han, MD, MMSc
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old and ≤ 80 years old & willingness to be randomized to either diet
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, and end of the study (26 weeks)
Awards & highlights

Study Summary

This trial will compare a low-carb KD to a low-fat MD to see how they affect exercise in people with heart failure, diabetes/pre-diabetes, metabolic syndrome, or obesity.

Who is the study for?
Adults aged 18-80 with heart failure, normal heart pumping function, and either diabetes, pre-diabetes, metabolic syndrome or obesity (BMI between 25-50) can join. They must have stable health for the past 3 months and be able to exercise on a treadmill. People with severe kidney disease, Type I diabetes, recent heart attacks or certain other serious health conditions cannot participate.Check my eligibility
What is being tested?
The trial is testing how well two diets - a low carbohydrate ketogenic diet and a low-fat mixed diet - help people with heart failure improve their ability to exercise. Participants will be randomly assigned to one of these diets to see which is more effective.See study design
What are the potential side effects?
Potential side effects from the ketogenic diet may include nutritional deficiencies, constipation or diarrhea due to high fat intake. The mixed diet could lead to unbalanced nutrition if not properly followed. Both diets require strict adherence that might affect lifestyle.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 80 years old and open to trying a new diet.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, and end of the study (26 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, and end of the study (26 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in maximal exercise performance
Secondary outcome measures
B-natriuretic peptide (BNP)
Change Stroke Volume(mL) via cardiovascular magnetic resonance imaging (CMR)
Change in Cardiac Output (L/min) via cardiovascular magnetic resonance imaging (CMR) .
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Low-fat mixed DietExperimental Treatment1 Intervention
This arm will be provided food consisting of ~25% fat, and the remaining calories from carbohydrate (~55% after accounting for protein at ~20%).
Group II: Ketogenic DietExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketogenic diet
2020
N/A
~680

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
830 Previous Clinical Trials
505,530 Total Patients Enrolled
17 Trials studying Heart Failure
52,675 Patients Enrolled for Heart Failure
United States Department of DefenseFED
865 Previous Clinical Trials
327,609 Total Patients Enrolled
1 Trials studying Heart Failure
81 Patients Enrolled for Heart Failure
Yuchi Han, MD, MMScPrincipal InvestigatorOhio State University
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Heart Failure
30 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current vacancies for individuals to enroll in this medical trial?

"Affirmative. Per the data available on clinicaltrials.gov, this study is actively looking for participants and was first posted on May 19th 2023 with a recent edit made October 7th of that year. 90 individuals are desired from 1 site in total."

Answered by AI

What is the estimated participant count of this clinical trial?

"Affirmative. Clinicaltrials.gov details confirm that this clinical trial, initially posted on May 19th 2023, is presently searching for participants. Approximately 90 patients must be recruited from a single site."

Answered by AI

To what demographic is enrollment for this trial limited?

"Candidates between 18 and 80 years old who suffer from heart failure can apply to be a part of this trial. Approximately 90 people are needed for the research study's completion."

Answered by AI

Is the eligibility criteria for this medical trial restricted to those younger than 20 years of age?

"The parameters for inclusion in this clinical trial necessitate that the participants are between 18 and 80 years old. Separately, there 25 trials specifically designed to evaluate minors while 759 studies focus on individuals over 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ketogenic Diet vs Mixed Diet in Patients With Heart Failure
Yuchi Han 2023. "Ketogenic Diet vs Mixed Diet in Patients With Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06081543.
~60 spots leftby Aug 2026
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