Clinical trial NCT05651243: Ketone Esters for Appetite, Cognition, and Cardiovascular Function in Individuals With Obesity and Insulin Resistance
Official title: Non-pharmacological Treatments for Obesity: Leveraging the Appetite Suppressive Effects of Hyperketonemia Through Exogenous Ketone Ingestion to Treat Obesity, Insulin Resistance, and Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: University of Southern Mississippi
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood pressure
timeFrame: Baseline (pre-ingestion)
measure: Blood pressure
timeFrame: 30 minutes post ingestion
measure: Blood pressure
timeFrame: 45 minutes post ingestion
measure: Blood pressure
timeFrame: 60 minutes post ingestion
measure: Blood pressure
timeFrame: 75 minutes post ingestion
measure: Blood pressure
timeFrame: 90 minutes post ingestion
measure: Blood pressure
timeFrame: 105 minutes post ingestion
measure: Heart Rate
timeFrame: Baseline (pre-ingestion)
measure: Heart Rate
timeFrame: 30 minutes post ingestion
measure: Heart Rate
timeFrame: 45 minutes post ingestion
measure: Heart Rate
timeFrame: 60 minutes post ingestion
measure: Heart Rate
timeFrame: 75 minutes post ingestion
measure: Heart Rate
timeFrame: 90 minutes post ingestion
measure: Heart Rate
timeFrame: 105 minutes post ingestion
measure: Heart Rate Variability
timeFrame: Baseline (pre-ingestion)
measure: Heart Rate Variability
timeFrame: 45 post ingestion
measure: Cardiac Baroreflex Sensitivity
timeFrame: 105 minutes post ingestion
measure: Hunger - Visual Digital Analog Scale (0-100)
timeFrame: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
measure: Fullness - Visual Digital Analog Scale (0-100)
timeFrame: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
measure: Desire to eat - Visual Digital Analog Scale (0-100)
timeFrame: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
measure: Prospective consumption of food - Visual Digital Analog Scale (0-100)
timeFrame: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
measure: Thirst - Visual Digital Analog Scale (0-100)
timeFrame: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
measure: Stroop Test - Digital Cognitive Function Test
timeFrame: Baseline, 75 minutes
measure: Go/No-go Test - Digital Cognitive Function Test
timeFrame: Baseline, 75 minutes
measure: Task Switching Task - Digital Cognitive Function Test
timeFrame: Baseline, 75 minutes
measure: Number Back Test - Digital Cognitive Function Test
timeFrame: Baseline, 75 minutes
measure: Digit Span Test - Digital Cognitive Function Test
timeFrame: Baseline, 75 minutes
Secondary outcomes:
measure: Prefrontal Cortex Oxygenation
timeFrame: Baseline, 90 minutes post ingestion
measure: Peripheral Blood Flow
timeFrame: Baseline, 30, 60 and 90 minutes post ingestion
measure: Peripheral Vascular Conductance
timeFrame: Baseline, 30, 60 and 90 minutes post ingestion
measure: Blood ketones
timeFrame: Baseline, 30, 60, 90, 120 minutes post ingestion
measure: Blood glucose
timeFrame: Baseline, 30, 60, 90, 120 minutes post ingestion
measure: Oxygen Consumption from Respiratory Gases
timeFrame: Baseline and continuous for 120 minutes
measure: Carbon Dioxide Produced from Respiratory Gases
timeFrame: Baseline and continuous for 120 minutes
Other outcomes:
Locations:
city: Hattiesburg
country: United States
facility: University of Southern Mississippi - School of Kinesiology and Nutrition
state: Mississippi
Study officials:
affiliation: University of Southern Mississippi
name: Austin J Graybeal, PhD
role: PRINCIPAL_INVESTIGATOR
References: