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

Primary Purpose

Obesity, Pre Diabetes, Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketone Ester Supplement
Placebo
Sponsored by
University of Southern Mississippi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adults between the ages of 18-50 years of age. Presence of one of the following: Body mass index (BMI) of = 30 kg/m2; a waist circumference of = 102 cm for males and = 88 cm for females Body fat percentage of = 28% for males and = 40% for females. The additional presence of one of the following: Fasting blood glucose of 100-125 mg/dl indicating prediabetes Fasting blood glucose of 126 mg/dl or greater indicating undiagnosed diabetes Previously diagnosed type II diabetes that is not insulin-dependent. Control Participant Eligibility: Normal weight (BMI < 25.00 kg/m2) A waist circumference of < 102 cm for males and < 88 cm for females, and No indication of diabetes based on the aforementioned criteria 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

Sites / Locations

  • University of Southern Mississippi - School of Kinesiology and NutritionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketone Ester

Placebo

Arm Description

Oral ketone ester supplement

Taste and viscosity matched placebo

Outcomes

Primary Outcome Measures

Blood pressure
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Blood pressure
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Blood pressure
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Blood pressure
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Blood pressure
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Blood pressure
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Blood pressure
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Heart Rate
Heart rate responses to sympathoexcitation
Heart Rate
Heart rate responses to sympathoexcitation
Heart Rate
Heart rate responses to sympathoexcitation
Heart Rate
Heart rate responses to sympathoexcitation
Heart Rate
Heart rate responses to sympathoexcitation
Heart Rate
Heart rate responses to sympathoexcitation
Heart Rate
Heart rate responses to sympathoexcitation
Heart Rate Variability
Index of cardiac autonomic control
Heart Rate Variability
Index of cardiac autonomic control
Cardiac Baroreflex Sensitivity
Changes in cardiac interval relative to changes in systolic blood pressure
Hunger - Visual Digital Analog Scale (0-100)
Changes in subjective rating of hunger
Fullness - Visual Digital Analog Scale (0-100)
Changes in subjective rating of fullness
Desire to eat - Visual Digital Analog Scale (0-100)
Changes in subjective rating of desire to eat
Prospective consumption of food - Visual Digital Analog Scale (0-100)
Changes in subjective rating of prospective consumption of food
Thirst - Visual Digital Analog Scale (0-100)
Changes in subjective rating of thirst
Stroop Test - Digital Cognitive Function Test
Changes in Stroop score
Go/No-go Test - Digital Cognitive Function Test
Changes in Go/No-go score
Task Switching Task - Digital Cognitive Function Test
Changes in Task Switching Task score
Number Back Test - Digital Cognitive Function Test
Changes in Number Back Test score
Digit Span Test - Digital Cognitive Function Test
Changes in Digit Span Test score

Secondary Outcome Measures

Prefrontal Cortex Oxygenation
Near-infrared spectroscopy
Peripheral Blood Flow
Doppler Ultrasound of Femoral Artery
Peripheral Vascular Conductance
Blood flow normalized to blood pressure (mL/min/mmHg)
Blood ketones
Ketone body level from capillary blood
Blood glucose
Blood glucose level from capillary blood
Oxygen Consumption from Respiratory Gases
Amount of oxygen consumed using indirect calorimetry
Carbon Dioxide Produced from Respiratory Gases
Amount of carbon dioxide produced using indirect calorimetry

Full Information

First Posted
November 3, 2022
Last Updated
May 8, 2023
Sponsor
University of Southern Mississippi
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1. Study Identification

Unique Protocol Identification Number
NCT05651243
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Mississippi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Pre Diabetes, Diabetes Mellitus, Type 2, Insulin Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketone Ester
Arm Type
Experimental
Arm Description
Oral ketone ester supplement
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Taste and viscosity matched placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone Ester Supplement
Intervention Description
Oral ingestion of a ketone supplement combined with a flavoring agent and diluted in water
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral ingestion of cellulose combined with a flavoring agent and diluted in water
Primary Outcome Measure Information:
Title
Blood pressure
Description
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Time Frame
Baseline (pre-ingestion)
Title
Blood pressure
Description
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Time Frame
30 minutes post ingestion
Title
Blood pressure
Description
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Time Frame
45 minutes post ingestion
Title
Blood pressure
Description
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Time Frame
60 minutes post ingestion
Title
Blood pressure
Description
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Time Frame
75 minutes post ingestion
Title
Blood pressure
Description
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Time Frame
90 minutes post ingestion
Title
Blood pressure
Description
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Time Frame
105 minutes post ingestion
Title
Heart Rate
Description
Heart rate responses to sympathoexcitation
Time Frame
Baseline (pre-ingestion)
Title
Heart Rate
Description
Heart rate responses to sympathoexcitation
Time Frame
30 minutes post ingestion
Title
Heart Rate
Description
Heart rate responses to sympathoexcitation
Time Frame
45 minutes post ingestion
Title
Heart Rate
Description
Heart rate responses to sympathoexcitation
Time Frame
60 minutes post ingestion
Title
Heart Rate
Description
Heart rate responses to sympathoexcitation
Time Frame
75 minutes post ingestion
Title
Heart Rate
Description
Heart rate responses to sympathoexcitation
Time Frame
90 minutes post ingestion
Title
Heart Rate
Description
Heart rate responses to sympathoexcitation
Time Frame
105 minutes post ingestion
Title
Heart Rate Variability
Description
Index of cardiac autonomic control
Time Frame
Baseline (pre-ingestion)
Title
Heart Rate Variability
Description
Index of cardiac autonomic control
Time Frame
45 post ingestion
Title
Cardiac Baroreflex Sensitivity
Description
Changes in cardiac interval relative to changes in systolic blood pressure
Time Frame
105 minutes post ingestion
Title
Hunger - Visual Digital Analog Scale (0-100)
Description
Changes in subjective rating of hunger
Time Frame
Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Title
Fullness - Visual Digital Analog Scale (0-100)
Description
Changes in subjective rating of fullness
Time Frame
Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Title
Desire to eat - Visual Digital Analog Scale (0-100)
Description
Changes in subjective rating of desire to eat
Time Frame
Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Title
Prospective consumption of food - Visual Digital Analog Scale (0-100)
Description
Changes in subjective rating of prospective consumption of food
Time Frame
Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Title
Thirst - Visual Digital Analog Scale (0-100)
Description
Changes in subjective rating of thirst
Time Frame
Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Title
Stroop Test - Digital Cognitive Function Test
Description
Changes in Stroop score
Time Frame
Baseline, 75 minutes
Title
Go/No-go Test - Digital Cognitive Function Test
Description
Changes in Go/No-go score
Time Frame
Baseline, 75 minutes
Title
Task Switching Task - Digital Cognitive Function Test
Description
Changes in Task Switching Task score
Time Frame
Baseline, 75 minutes
Title
Number Back Test - Digital Cognitive Function Test
Description
Changes in Number Back Test score
Time Frame
Baseline, 75 minutes
Title
Digit Span Test - Digital Cognitive Function Test
Description
Changes in Digit Span Test score
Time Frame
Baseline, 75 minutes
Secondary Outcome Measure Information:
Title
Prefrontal Cortex Oxygenation
Description
Near-infrared spectroscopy
Time Frame
Baseline, 90 minutes post ingestion
Title
Peripheral Blood Flow
Description
Doppler Ultrasound of Femoral Artery
Time Frame
Baseline, 30, 60 and 90 minutes post ingestion
Title
Peripheral Vascular Conductance
Description
Blood flow normalized to blood pressure (mL/min/mmHg)
Time Frame
Baseline, 30, 60 and 90 minutes post ingestion
Title
Blood ketones
Description
Ketone body level from capillary blood
Time Frame
Baseline, 30, 60, 90, 120 minutes post ingestion
Title
Blood glucose
Description
Blood glucose level from capillary blood
Time Frame
Baseline, 30, 60, 90, 120 minutes post ingestion
Title
Oxygen Consumption from Respiratory Gases
Description
Amount of oxygen consumed using indirect calorimetry
Time Frame
Baseline and continuous for 120 minutes
Title
Carbon Dioxide Produced from Respiratory Gases
Description
Amount of carbon dioxide produced using indirect calorimetry
Time Frame
Baseline and continuous for 120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults between the ages of 18-50 years of age. Presence of one of the following: Body mass index (BMI) of = 30 kg/m2; a waist circumference of = 102 cm for males and = 88 cm for females Body fat percentage of = 28% for males and = 40% for females. The additional presence of one of the following: Fasting blood glucose of 100-125 mg/dl indicating prediabetes Fasting blood glucose of 126 mg/dl or greater indicating undiagnosed diabetes Previously diagnosed type II diabetes that is not insulin-dependent. Control Participant Eligibility: Normal weight (BMI < 25.00 kg/m2) A waist circumference of < 102 cm for males and < 88 cm for females, and No indication of diabetes based on the aforementioned criteria 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Austin J Graybeal, PhD
Phone
6012665996
Email
austin.graybeal@usm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Austin J Graybeal, PhD
Organizational Affiliation
University of Southern Mississippi
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern Mississippi - School of Kinesiology and Nutrition
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39406
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Austin J Graybeal, PhD
Phone
601-266-5996
Email
austin.graybeal@usm.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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