Ketone Esters for Appetite, Cognition, and Cardiovascular Function in Individuals With Obesity and Insulin Resistance

University of Southern Mississippi

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Ketone Ester Supplement; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05651243

22-877

Details and patient eligibility

About

The goal of this single-blind randomized placebo-controlled trial is to test the effects of an oral ketone supplement on appetite, cognition, metabolism, and cardiovascular function in individuals with obesity and insulin resistance.

The main question[s] it aims to answer are:

• Does taking the ketone supplement reduce appetite and improve cognition?
• How does the ketone supplement alter metabolism and cardiovascular function?

Participants will be asked to consume a randomly assigned ketone ester supplement or a placebo and testing will be done to see how the supplement affects the following compared to a placebo:

• appetite,
• cognition,
• metabolism
• cardiovascular function

Researchers will compare individuals with obesity and insulin resistance to individuals with normal weight and no insulin resistance to see if the ketone supplement affects groups differently.

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults between the ages of 18-50 years of age.
• Presence of metabolic sydnrome

Control Participant Eligibility:

• A waist circumference of < 102 cm for males and < 88 cm for females, and
• No indication of metabolic syndrome

Exclusion criteria

• Pregnant
• Breastfeeding or lactating
• Missing any limbs or part of a limb
• Having a substantial amount of metal implants (metal plates or complete joint replacements)
• Having a pacemaker or any other electrical implant
• Type I diabetes
• Gestational diabetes
• Taking insulin
• Any history of severe traumatic brain injury or mild traumatic brain injury within the last two years
• Kidney disease
• Liver disease
• Thyroid disease
• Any diagnosed neurological or neurodegenerative diseases
• Any surgeries that would impact swallowing and/or digestion
• Being on a ketogenic diet or having been on a ketogenic diet in the last 6 months
• Having received ionizing radiation from a medical procedure within the last 30 days
• Being on a medically prescribed diet

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

20 participants in 2 patient groups, including a placebo group

Ketone Ester

Experimental group

Description:

Oral ketone ester supplement

Treatment:

Dietary Supplement: Ketone Ester Supplement

Placebo

Placebo Comparator group

Description:

Taste and viscosity matched placebo

Treatment:

Other: Placebo