Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOhio State University
About this trial
This study is being done to evaluate how a ketone ester (KE) supplement affects heart function and health in people with diabetes compared to a placebo supplement (made with standard food ingredients that do not contain ketone esters).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old and ≤ 80 years old
Type II Diabetes Mellitus
Stable medical therapy for at least 1 months as determined by the treating physician (no plan to change between the two testing sessions)
Dose of oral diuretics changes allowed, but must be stable for 1 week prior to randomization
Disqualifiers
Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the trial
Known allergy or sensitivity to Gadolinium based contrast agents
Implanted pacemaker, cardioverter defibrillator, cardiac resynchronization therapy, left ventricular assist device
Other metallic implants/aneurysm clips that are contraindicated in MRI
Trial design
Design model
Crossover
Treatments tested in this trial
Ketone Ester Acute
Dietary supplementParticipants will undertake a controlled feeding intervention where they will consume 25g of C8 Ketone Diester with a meal, and images obtained before and after consumption. The supplement powder contains 12.5 g C8 Diester, sodium caseinate and soluble corn fiber, per serving. The powder contains 120 kcal, 0 g fat, 3 g carbohydrate, and 0 g protein. A standardized meal will be provided to subjects to consume with their allocated supplement during the MRI visits. This meal is formulated with whole foods (i.e. chicken, rice, and a fruit bar) as a mix of macronutrients (29% protein, 3% fat, and 68% carbohydrate - not including the supplements). The meal consists of \~700kcal of food and will be standardized between all visits and subjects.
Placebo Acute
Dietary supplementParticipants will undertake a controlled feeding intervention where they will drink two servings of the placebo with a meal, and images obtained before and after consumption. The placebo is flavor, energy, volume, and macronutrient matched will be given to patients as part of the placebo arm of the study. This placebo will not contain any BHB, which will be replaced with a similar caloric content of fat in the form of canola oil.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Keto Ester AcuteExperimental treatment 1 intervention
Group B: Placebo AcutePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Cardiac MRI measures of cardiac function
Participants undergo MRI scans, conducted by trained professionals. MRI imaging analyses will determine cardiac function. The images will be analyzed by trained imaging professionals to determine overall change in cardiac function.
Time frame
Baseline, 2 weeksSecondary outcomes
1
Change in Quality of Life Questionnaire
Participants will complete a quality of life questionnaire several times throughout the study. The questions are divided into three areas: Dyspnea, Fatigue and Emotional Function. The scores for each are added up and divided by the number of questions. A 7-point scale is used for areas where 1 is the best and 7 is the worst.
Time frame
Baseline, 2 weeks2
Metabolic Panel
Changes in metabolic blood panel will be assessed at lab visits.
Time frame
Baseline, 2 weeks3
Lipid Panel
Changes in lipid blood panel will be assessed at lab visits.
Time frame
Baseline, 2 weeks4
B-natriuretic peptide (BNP)
Changes in BNP (pg/mL) will be assessed at lab visits.
Time frame
Baseline, 2 weeksOther outcomes
1
Change in fat storage
Participants undergo MRI scans, conducted by trained professionals. MRI imaging analyses will determine fat storage.
Time frame
Baseline, 2 weeksSponsors and contacts
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Source ClinicalTrials.gov