Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 6, 2023

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
Heart Failure With Preserved Ejection FractionType 2 DiabetesMetabolic Syndrome
Interventions
DIETARY_SUPPLEMENT

C8 Ketone Supplement

"Nutritional and Dietary Manipulation:~Participants will undertake a controlled feeding intervention where they will drink the supplement twice a day for 6 weeks. The supplement is a C8 Ketone Diester supplement. The beverage contains 25 g of C8 Ketone Diester emulsified in a matrix of water, whey protein concentrate, modified gum acacia, natural and artificial flavors and cocoa powder. It contains 210 kcal, 0.5 g fat, 2 g carbohydrate, and 2 g protein. For the proposed studies all participants will drink 5.4 oz of supplement, delivering 50g of C8 Ketone Supplement daily in a split serving fashion where half will be consumed in the morning with breakfast, and the other half with lunch."

DIETARY_SUPPLEMENT

Placebo

"Nutritional and Dietary Manipulation:~Participants will undertake a controlled feeding intervention where they will drink the placebo twice a day, once at breakfast, and once around lunch time for 6 weeks. 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 ketones (BHB), which will be replaced with a similar caloric content of fat in the form of canola oil."

DIETARY_SUPPLEMENT

Ketone Ester Acute

"Nutritional and Dietary Manipulation:~Participants will undertake a controlled feeding intervention where they will drink two servings of the supplement at once (50g total C8 Ketone Supplement), and images obtained before and after consumption. The supplement is a C8 Ketone Supplement. The beverage contains 25 g of C8 Ketone Diester emulsified in a matrix of water, whey protein concentrate, modified gum acacia, natural and artificial flavors and cocoa powder. It contains 210 kcal, 0.5 g fat, 2 g carbohydrate, and 2 g protein."

DIETARY_SUPPLEMENT

Placebo Acute

Participants will undertake a controlled feeding intervention where they will drink two servings of the placebo at once (50g total placebo), 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.

Trial Locations (1)

43210

RECRUITING

The Ross Heart Hospital, Columbus

All Listed Sponsors
lead

Ohio State University

OTHER