Ketone Esters for Appetite, Cognition, and Cardiovascular Function in Individuals With Obesity and Insulin Resistance
- Conditions
- Metabolic Syndrome
- Interventions
- Dietary Supplement: Ketone Ester SupplementOther: Placebo
- Registration Number
- NCT05651243
- Lead Sponsor
- University of Southern Mississippi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Ketone Ester Ketone Ester Supplement Oral ketone ester supplement Placebo Placebo Taste and viscosity matched placebo
- Primary Outcome Measures
Name Time Method Number Back Test - Digital Cognitive Function Test Baseline, 75 minutes Changes in Number Back Test score
Blood pressure 105 minutes post ingestion Blood pressure responses (systolic and diastolic) to sympathoexcitation
Heart Rate 105 minutes post ingestion Heart rate responses to sympathoexcitation
Digit Span Test - Digital Cognitive Function Test Baseline, 75 minutes Changes in Digit Span Test score
Stroop Test - Digital Cognitive Function Test Baseline, 75 minutes Changes in Stroop score
Task Switching Task - Digital Cognitive Function Test Baseline, 75 minutes Changes in Task Switching Task score
Prospective consumption of food - Visual Digital Analog Scale (0-100) Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion Changes in subjective rating of prospective consumption of food
Hunger - Visual Digital Analog Scale (0-100) Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion Changes in subjective rating of hunger
Heart Rate Variability 45 post ingestion Index of cardiac autonomic control
Desire to eat - Visual Digital Analog Scale (0-100) 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) Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion Changes in subjective rating of thirst
Cardiac Baroreflex Sensitivity 105 minutes post ingestion Changes in cardiac interval relative to changes in systolic blood pressure
Fullness - Visual Digital Analog Scale (0-100) Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion Changes in subjective rating of fullness
Go/No-go Test - Digital Cognitive Function Test Baseline, 75 minutes Changes in Go/No-go score
- Secondary Outcome Measures
Name Time Method Peripheral Vascular Conductance Baseline, 30, 60 and 90 minutes post ingestion Blood flow normalized to blood pressure (mL/min/mmHg)
Blood glucose Baseline, 30, 60, 90, 120 minutes post ingestion Blood glucose level from capillary blood
Prefrontal Cortex Oxygenation Baseline, 90 minutes post ingestion Near-infrared spectroscopy
Peripheral Blood Flow Baseline, 30, 60 and 90 minutes post ingestion Doppler Ultrasound of Femoral Artery
Oxygen Consumption from Respiratory Gases Baseline and continuous for 120 minutes Amount of oxygen consumed using indirect calorimetry
Blood ketones Baseline, 30, 60, 90, 120 minutes post ingestion Ketone body level from capillary blood
Carbon Dioxide Produced from Respiratory Gases Baseline and continuous for 120 minutes Amount of carbon dioxide produced using indirect calorimetry
Trial Locations
- Locations (1)
University of Southern Mississippi - School of Kinesiology and Nutrition
🇺🇸Hattiesburg, Mississippi, United States