Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function

NCT06078683 | Recruiting

• 2 other identifiers: 2022H0376CDMRP-PR212399-F
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Type 2 Diabetes; Ketone Body Metabolism; Ketones, Metabolism

Outcome Measures

Primary Outcomes (1)

• Change in CMR 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.

  Baseline, 2 weeks

Secondary Outcomes (5)

• Change in Quality of Life Questionnaire

  Baseline, 2 weeks

• Metabolic Panel

  Baseline, 2 weeks

• Lipid Panel

  Baseline, 2 weeks

• B-natriuretic peptide (BNP)

  Baseline, 2 weeks

• Change in Cardiac function after acute ingestion of KE or placebo

  Baseline, 2 weeks

Other Outcomes (1)

• Change in fat storage

  Baseline, 2 weeks

Study Arms (2)

Keto Ester Acute

EXPERIMENTAL

This arm will provide a Ketone Ester supplement + a meal for consumption.

Dietary Supplement: Ketone Ester Acute

Placebo Acute

PLACEBO COMPARATOR

This arm will provide a Placebo beverage + a meal for consumption.

Dietary Supplement: Placebo Acute

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.

Keto Ester Acute

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.

Placebo Acute

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Body Mass Index (BMI) ≥ 25
• Ability to participate in exercise treadmill testing (only if CPET is performed)
• Ability to sign written consent

You may not qualify if:

• 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
• Claustrophobia
• History of severe kidney disease with eGFR\<30 ml/kg/1.73m2
• Type I diabetes
• History of diabetic ketoacidosis
• Prior diagnosis of oxygen dependent pulmonary disease
• Body Mass Index (BMI) \< 25
• Major surgery (major according to the investigator's assessment) performed within 90 days prior to screening, or major scheduled elective surgery (e.g. hip replacement) within 90 days after screening
• Acute or chronic liver disease, defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening
• Gastrointestinal surgery or gastrointestinal disorder that might interfere with supplement consumption. Prior bariatric surgery allowed if weight-stable for past 3 months.
• Any documented active or suspected malignancy or history of malignancy within 2 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix, or low-risk prostate cancer (subjects with pre-treatment prostate-specific antigen levels of \<10 ng/mL, and biopsy Gleason scores of ≤6 and clinical stage T1c or T2a)
• Presence of any disease other than diabetes that results in a life expectancy of \<1 year (in the opinion of the investigator)

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ross Heart Hospital

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Ketosis

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Acidosis; Acid-Base Imbalance

Study Officials

• Yuchi Han, MD, MMSc

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Debbie Scandling, BS

CONTACT

614-688-5623; debbie.scandling@osumc.edu

Christopher Crabtree, MS

CONTACT

crabtree.223@osu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Clinical, Cardiovascular Medicine

Model Details: Randomized, double-blinded, placebo-controlled, crossover study

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 12, 2023
• Study Start: June 6, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)