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Ketone Supplement 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline1, end of first intervention, baseline2, end of second intervention

Awards & highlights

Study Summary

This trial tests if a ketone drink can help heart failure patients. It compares it to a placebo drink.

Who is the study for?

Adults aged 18-80 with heart failure, BMI of 25-50 or Type II Diabetes/prediabetes, stable heart and diabetes medications for at least 3 months, and able to do treadmill tests. Excludes those with recent major surgeries, certain heart conditions like transplants or severe arrhythmias, pregnant women, drug/alcohol abuse history, severe kidney disease, uncontrolled blood pressure or life expectancy less than a year.Check my eligibility

What is being tested?

The trial is testing the effects of a ketone ester beverage on exercise tolerance and cardiac function in people with heart failure. Participants will be randomly assigned to receive either the ketone ester drink or a placebo (a non-ketone standard beverage) to compare outcomes.See study design

What are the potential side effects?

Potential side effects may include gastrointestinal discomfort due to supplement intake. Since it's not specified for this trial's supplements specifically, common side effects from similar products can include nausea, stomach upset or an unpleasant taste.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline1, end of first intervention, baseline2, end of second intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline1, end of first intervention, baseline2, end of second intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline1, end of first intervention, baseline2, end of second intervention 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 in CMR measures of cardiac function

Change in Cardiac function after acute ingestion of KE or placebo

+4 more

Other outcome measures

Change in fat storage

Change in stiffness

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Ketone EsterExperimental Treatment1 Intervention

This arm will provide a Keto Ester Beverage for consumption.

Group II: Keto Ester AcuteExperimental Treatment1 Intervention

This arm will provide a Keto Ester Beverage for consumption.

Group III: PlaceboPlacebo Group1 Intervention

This arm will provide a Placebo Beverage for consumption.

Group IV: Placebo AcutePlacebo Group1 Intervention

This arm will provide a Placebo Beverage for consumption.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

830 Previous Clinical Trials

505,590 Total Patients Enrolled

Yuchi Han, MD, MMScPrincipal InvestigatorOhio State University

1 Previous Clinical Trials

90 Total Patients Enrolled

Frequently Asked Questions

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

Is enrollment for this medical study open to those under the age of sixty?

"This clinical trial requires that applicants are between 18 and 80 years old. Separately, there exist 56 trials catered to those below the age of majority, as well as 1,205 studies for individuals over 65."

Answered by AI

Who is eligible for participation in this clinical research?

"To become part of this medical trial, potential patients must have been diagnosed with heart failure and be between the ages of 18-80. Currently, approximately 30 candidates are being recruited."

Answered by AI

How many participants has this clinical trial recruited thus far?

"Affirmative. Clinicaltrials.gov contains information that demonstrates this trial is currently enrolling patients, having been initially posted on June 6th 2023 and recently updated on October 7th 2023. The research project requires 30 participants from a single medical facility to take part in the study."

Answered by AI

Is the study currently accepting volunteers?

"As evidenced on clinicaltrials.gov, this research initiative is recruiting participants currently. Initially posted on June 6th 2023 and most recently updated on October 7th of the same year, all interested parties should apply soon."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function

Yuchi Han 2023. "Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06078683.

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