Non-pharmacological Treatments for Obesity: Leveraging the Appetite Suppressive Effects of Hyperketonemia Through Exogenous Ketone Ingestion to Treat Obesity, Insulin Resistance, and Cognition
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Hunger - Visual Digital Analog Scale (0-100)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
Ketone Ester
Oral ketone ester supplement
Intervention: Ketone Ester Supplement (Dietary Supplement)
Placebo
Taste and viscosity matched placebo
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Hunger - Visual Digital Analog Scale (0-100)
Time Frame: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Changes in subjective rating of hunger
Cardiac Baroreflex Sensitivity
Time Frame: 105 minutes post ingestion
Changes in cardiac interval relative to changes in systolic blood pressure
Fullness - Visual Digital Analog Scale (0-100)
Time Frame: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Changes in subjective rating of fullness
Number Back Test - Digital Cognitive Function Test
Time Frame: Baseline, 75 minutes
Changes in Number Back Test score
Blood pressure
Time Frame: 105 minutes post ingestion
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Heart Rate
Time Frame: 105 minutes post ingestion
Heart rate responses to sympathoexcitation
Digit Span Test - Digital Cognitive Function Test
Time Frame: Baseline, 75 minutes
Changes in Digit Span Test score
Stroop Test - Digital Cognitive Function Test
Time Frame: Baseline, 75 minutes
Changes in Stroop score
Task Switching Task - Digital Cognitive Function Test
Time Frame: Baseline, 75 minutes
Changes in Task Switching Task score
Prospective consumption of food - Visual Digital Analog Scale (0-100)
Time Frame: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Changes in subjective rating of prospective consumption of food
Heart Rate Variability
Time Frame: 45 post ingestion
Index of cardiac autonomic control
Desire to eat - Visual Digital Analog Scale (0-100)
Time Frame: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Changes in subjective rating of desire to eat
Thirst - Visual Digital Analog Scale (0-100)
Time Frame: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Changes in subjective rating of thirst
Go/No-go Test - Digital Cognitive Function Test
Time Frame: Baseline, 75 minutes
Changes in Go/No-go score
Heart Rate
Time Frame: 45 minutes post ingestion
Heart rate responses to sympathoexcitation
Heart Rate
Time Frame: 60 minutes post ingestion
Heart rate responses to sympathoexcitation
Blood pressure
Time Frame: 75 minutes post ingestion
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Blood pressure
Time Frame: 90 minutes post ingestion
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Blood pressure
Time Frame: Baseline (pre-ingestion)
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Blood pressure
Time Frame: 30 minutes post ingestion
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Blood pressure
Time Frame: 45 minutes post ingestion
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Blood pressure
Time Frame: 60 minutes post ingestion
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Heart Rate
Time Frame: Baseline (pre-ingestion)
Heart rate responses to sympathoexcitation
Heart Rate
Time Frame: 30 minutes post ingestion
Heart rate responses to sympathoexcitation
Heart Rate
Time Frame: 75 minutes post ingestion
Heart rate responses to sympathoexcitation
Heart Rate
Time Frame: 90 minutes post ingestion
Heart rate responses to sympathoexcitation
Heart Rate Variability
Time Frame: Baseline (pre-ingestion)
Index of cardiac autonomic control
Secondary Outcomes
- Peripheral Vascular Conductance(Baseline, 30, 60 and 90 minutes post ingestion)
- Blood glucose(Baseline, 30, 60, 90, 120 minutes post ingestion)
- Prefrontal Cortex Oxygenation(Baseline, 90 minutes post ingestion)
- Peripheral Blood Flow(Baseline, 30, 60 and 90 minutes post ingestion)
- Oxygen Consumption from Respiratory Gases(Baseline and continuous for 120 minutes)
- Blood ketones(Baseline, 30, 60, 90, 120 minutes post ingestion)
- Carbon Dioxide Produced from Respiratory Gases(Baseline and continuous for 120 minutes)
Investigators
Austin Graybeal
Assistant Professor
University of Southern Mississippi