90 Participants Needed

Ketogenic Diet vs Mixed Diet for Heart Failure

DS
AM
Overseen ByAlyssa Marie Castillo, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is comparing a ketogenic diet and a low-fat diet in people with heart failure and diabetes or related conditions. The goal is to see which diet improves exercise tolerance better. The ketogenic diet helps the body use fat for energy, while the low-fat diet focuses on reducing fat intake.

Will I have to stop taking my current medications?

The trial requires that your current medications for heart failure and diabetes remain stable for at least 3 months before and during the study. However, changes in the dose of oral diuretics are allowed if they are stable for 1 week before starting the trial.

Is the ketogenic diet safe for humans?

Research shows that ketogenic diets, which are low in carbohydrates and high in fats, are generally safe for weight loss and can improve certain heart health markers like triglycerides and good cholesterol levels. However, more long-term studies are needed to fully understand their safety over extended periods.12345

How does the ketogenic diet treatment for heart failure differ from other treatments?

The ketogenic diet is unique for heart failure treatment because it focuses on increasing ketone body metabolism, which provides an alternative energy source for the heart, potentially improving cardiac function. Unlike standard treatments, it involves a high-fat, low-carbohydrate diet that may enhance energy production in the failing heart.678910

What data supports the effectiveness of the ketogenic diet treatment for heart failure?

Research suggests that low-carbohydrate diets, like the ketogenic diet, can improve heart function by reducing insulin resistance and improving blood sugar control, which may help people with heart failure. Additionally, these diets have been shown to aid in weight loss and improve cardiovascular risk factors, which can be beneficial for heart health.12111213

Who Is on the Research Team?

YH

Yuchi Han, MD, MMSc

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My heart and diabetes medications have been stable for the last 3 months.
My BMI is between 25 and 50, or I have Type 2 Diabetes, prediabetes, or metabolic syndrome.
Your heart function tests show certain abnormalities related to the pressure in your lungs and blood vessels.
See 5 more

Exclusion Criteria

I am not pregnant, breastfeeding, nor plan to become pregnant during the study.
I have not had a heart attack or severe heart issue in the last 30 days.
My kidney function is severely reduced.
See 33 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Baseline Monitoring

Participants apply a sensor one week prior to starting the study to capture baseline metabolic status

1 week
1 visit (in-person)

Initial Diet Intervention

Participants follow a specified diet with provided food and dietary coaching

6 weeks
Weekly visits (in-person or virtual)

Free-living Diet Period

Participants continue the diet with educational materials and coaching, without provided food

20-22 weeks
Frequent coaching sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Ketogenic Diet
  • Mixed Diet
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Low-fat mixed DietExperimental Treatment1 Intervention
Group II: Ketogenic DietExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Published Research Related to This Trial

In patients with diabetic cardiomyopathy (DMCM), low carbohydrate (LC) diets may improve glycemic control and reduce insulin resistance, potentially leading to better heart function and reduced medication needs.
Traditional low fat (LF) diets, which are higher in carbohydrates, could worsen insulin resistance and glycemic control in DMCM patients, suggesting that LC diets may be a safer and more effective dietary approach for managing heart failure in this population.
Low Carbohydrate Diets for Diabetic Cardiomyopathy: A Hypothesis.Kleissl-Muir, S., Rasmussen, B., Owen, A., et al.[2023]
Low-carbohydrate/high-protein diets were found to be more effective than low-fat/high-carbohydrate diets for weight loss and improving cardiovascular risk factors, based on a systematic review of 13 randomized controlled trials lasting at least 6 months.
Participants showed a preference for low-carbohydrate diets, as indicated by a higher dropout rate in the low-fat diet group, suggesting that these diets may be more sustainable for long-term weight management.
Systematic review of randomized controlled trials of low-carbohydrate vs. low-fat/low-calorie diets in the management of obesity and its comorbidities.Hession, M., Rolland, C., Kulkarni, U., et al.[2022]
Individuals on a very-low-carbohydrate ketogenic diet (VLCKD) experienced greater long-term weight loss compared to those on a conventional low-fat diet (LFD), with a mean difference of -0.91 kg across 13 studies involving 1415 patients.
The VLCKD also led to improvements in cardiovascular risk factors, including lower triglycerides and diastolic blood pressure, as well as increased HDL cholesterol, suggesting it may be a beneficial approach for managing obesity and related health risks.
Very-low-carbohydrate ketogenic diet v. low-fat diet for long-term weight loss: a meta-analysis of randomised controlled trials.Bueno, NB., de Melo, IS., de Oliveira, SL., et al.[2022]

Citations

Low Carbohydrate Diets for Diabetic Cardiomyopathy: A Hypothesis. [2023]
Systematic review of randomized controlled trials of low-carbohydrate vs. low-fat/low-calorie diets in the management of obesity and its comorbidities. [2022]
Very-low-carbohydrate ketogenic diet v. low-fat diet for long-term weight loss: a meta-analysis of randomised controlled trials. [2022]
Effects of low-carbohydrate diets v. low-fat diets on body weight and cardiovascular risk factors: a meta-analysis of randomised controlled trials. [2022]
Adherence to low-carbohydrate and low-fat diets in relation to weight loss and cardiovascular risk factors. [2021]
Experience with MAD on children with epilepsy in Egypt after classic KD failure. [2018]
Long-term effects of a very-low-carbohydrate weight loss diet compared with an isocaloric low-fat diet after 12 mo. [2023]
Ketogenic diets for weight loss: A review of their principles, safety and efficacy. [2022]
[Potential implications of ketone body metabolism changes and ketogenic therapy in the treatment of heart failure]. [2023]
Ketogenic Diet and Cardiac Substrate Metabolism. [2022]
Ketone metabolism in the failing heart. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Three consecutive weeks of nutritional ketosis has no effect on cognitive function, sleep, and mood compared with a high-carbohydrate, low-fat diet in healthy individuals: a randomized, crossover, controlled trial. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Effects of Hypocaloric Low-Fat, Ketogenic, and Ketogenic and Ketone Supplement Diets on Aldosterone and Renin. [2023]
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