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

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05651243
• Other study ID #: 22-877
• Status: Completed
• Phase: N/A
• Start date: December 28, 2022
• Est. completion date: December 29, 2023

Study information

• Verified date: May 2024
• Source: University of Southern Mississippi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 29, 2023
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Obesity

Intervention

Dietary Supplement:
• Ketone Ester Supplement
Oral ingestion of a ketone supplement combined with a flavoring agent and diluted in water

Other:
• Placebo
Oral ingestion of cellulose combined with a flavoring agent and diluted in water

Locations

Country	Name	City	State
United States	University of Southern Mississippi - School of Kinesiology and Nutrition	Hattiesburg	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Mississippi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Blood pressure responses (systolic and diastolic) to sympathoexcitation	Baseline (pre-ingestion)
Primary	Blood pressure	Blood pressure responses (systolic and diastolic) to sympathoexcitation	30 minutes post ingestion
Primary	Blood pressure	Blood pressure responses (systolic and diastolic) to sympathoexcitation	45 minutes post ingestion
Primary	Blood pressure	Blood pressure responses (systolic and diastolic) to sympathoexcitation	60 minutes post ingestion
Primary	Blood pressure	Blood pressure responses (systolic and diastolic) to sympathoexcitation	75 minutes post ingestion
Primary	Blood pressure	Blood pressure responses (systolic and diastolic) to sympathoexcitation	90 minutes post ingestion
Primary	Blood pressure	Blood pressure responses (systolic and diastolic) to sympathoexcitation	105 minutes post ingestion
Primary	Heart Rate	Heart rate responses to sympathoexcitation	Baseline (pre-ingestion)
Primary	Heart Rate	Heart rate responses to sympathoexcitation	30 minutes post ingestion
Primary	Heart Rate	Heart rate responses to sympathoexcitation	45 minutes post ingestion
Primary	Heart Rate	Heart rate responses to sympathoexcitation	60 minutes post ingestion
Primary	Heart Rate	Heart rate responses to sympathoexcitation	75 minutes post ingestion
Primary	Heart Rate	Heart rate responses to sympathoexcitation	90 minutes post ingestion
Primary	Heart Rate	Heart rate responses to sympathoexcitation	105 minutes post ingestion
Primary	Heart Rate Variability	Index of cardiac autonomic control	Baseline (pre-ingestion)
Primary	Heart Rate Variability	Index of cardiac autonomic control	45 post ingestion
Primary	Cardiac Baroreflex Sensitivity	Changes in cardiac interval relative to changes in systolic blood pressure	105 minutes post ingestion
Primary	Hunger - Visual Digital Analog Scale (0-100)	Changes in subjective rating of hunger	Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Primary	Fullness - Visual Digital Analog Scale (0-100)	Changes in subjective rating of fullness	Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Primary	Desire to eat - Visual Digital Analog Scale (0-100)	Changes in subjective rating of desire to eat	Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Primary	Prospective consumption of food - Visual Digital Analog Scale (0-100)	Changes in subjective rating of prospective consumption of food	Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Primary	Thirst - Visual Digital Analog Scale (0-100)	Changes in subjective rating of thirst	Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Primary	Stroop Test - Digital Cognitive Function Test	Changes in Stroop score	Baseline, 75 minutes
Primary	Go/No-go Test - Digital Cognitive Function Test	Changes in Go/No-go score	Baseline, 75 minutes
Primary	Task Switching Task - Digital Cognitive Function Test	Changes in Task Switching Task score	Baseline, 75 minutes
Primary	Number Back Test - Digital Cognitive Function Test	Changes in Number Back Test score	Baseline, 75 minutes
Primary	Digit Span Test - Digital Cognitive Function Test	Changes in Digit Span Test score	Baseline, 75 minutes
Secondary	Prefrontal Cortex Oxygenation	Near-infrared spectroscopy	Baseline, 90 minutes post ingestion
Secondary	Peripheral Blood Flow	Doppler Ultrasound of Femoral Artery	Baseline, 30, 60 and 90 minutes post ingestion
Secondary	Peripheral Vascular Conductance	Blood flow normalized to blood pressure (mL/min/mmHg)	Baseline, 30, 60 and 90 minutes post ingestion
Secondary	Blood ketones	Ketone body level from capillary blood	Baseline, 30, 60, 90, 120 minutes post ingestion
Secondary	Blood glucose	Blood glucose level from capillary blood	Baseline, 30, 60, 90, 120 minutes post ingestion
Secondary	Oxygen Consumption from Respiratory Gases	Amount of oxygen consumed using indirect calorimetry	Baseline and continuous for 120 minutes
Secondary	Carbon Dioxide Produced from Respiratory Gases	Amount of carbon dioxide produced using indirect calorimetry	Baseline and continuous for 120 minutes