Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT06078683
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketone Ester Acute — DIETARY_SUPPLEMENT
    Participants 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_SUPPLEMENT
    Participants 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.

Study Details

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).

Key Dates

Start date
Jun 6, 2023
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Keto Ester Acute
    This arm will provide a Ketone Ester supplement + a meal for consumption.
  • Placebo Comparator: Placebo Acute
    This arm will provide a Placebo beverage + a meal for consumption.

Primary Outcome Measure

Change in Cardiac MRI measures of cardiac function [ Time Frame: Baseline, 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ross Heart HospitalColumbusOhio43210
Debbie Scandling
[email protected]
614-688-5623
Orlando Simonetti, Ph.D. (SUB_INVESTIGATOR)
Jeff Volek, Ph.D. (SUB_INVESTIGATOR)

Find similar trials in Columbus, OH

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
The Ross Heart Hospital· Columbus, OH

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