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

Sponsor
University of Southern Mississippi (Other)
Overall Status
Recruiting
CT.gov ID
NCT05651243
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
4.3
Anticipated Duration (Months)
6.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Ketone Ester Supplement
  • Other: Placebo
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 20, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ketone Ester

Oral ketone ester supplement

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

Taste and viscosity matched placebo

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

Outcome Measures

Primary Outcome Measures

  1. Blood pressure [Baseline (pre-ingestion)]

    Blood pressure responses (systolic and diastolic) to sympathoexcitation

  2. Blood pressure [30 minutes post ingestion]

    Blood pressure responses (systolic and diastolic) to sympathoexcitation

  3. Blood pressure [45 minutes post ingestion]

    Blood pressure responses (systolic and diastolic) to sympathoexcitation

  4. Blood pressure [60 minutes post ingestion]

    Blood pressure responses (systolic and diastolic) to sympathoexcitation

  5. Blood pressure [75 minutes post ingestion]

    Blood pressure responses (systolic and diastolic) to sympathoexcitation

  6. Blood pressure [90 minutes post ingestion]

    Blood pressure responses (systolic and diastolic) to sympathoexcitation

  7. Blood pressure [105 minutes post ingestion]

    Blood pressure responses (systolic and diastolic) to sympathoexcitation

  8. Heart Rate [Baseline (pre-ingestion)]

    Heart rate responses to sympathoexcitation

  9. Heart Rate [30 minutes post ingestion]

    Heart rate responses to sympathoexcitation

  10. Heart Rate [45 minutes post ingestion]

    Heart rate responses to sympathoexcitation

  11. Heart Rate [60 minutes post ingestion]

    Heart rate responses to sympathoexcitation

  12. Heart Rate [75 minutes post ingestion]

    Heart rate responses to sympathoexcitation

  13. Heart Rate [90 minutes post ingestion]

    Heart rate responses to sympathoexcitation

  14. Heart Rate [105 minutes post ingestion]

    Heart rate responses to sympathoexcitation

  15. Heart Rate Variability [Baseline (pre-ingestion)]

    Index of cardiac autonomic control

  16. Heart Rate Variability [45 post ingestion]

    Index of cardiac autonomic control

  17. Cardiac Baroreflex Sensitivity [105 minutes post ingestion]

    Changes in cardiac interval relative to changes in systolic blood pressure

  18. Hunger - Visual Digital Analog Scale (0-100) [Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion]

    Changes in subjective rating of hunger

  19. Fullness - Visual Digital Analog Scale (0-100) [Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion]

    Changes in subjective rating of fullness

  20. 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

  21. 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

  22. Thirst - Visual Digital Analog Scale (0-100) [Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion]

    Changes in subjective rating of thirst

  23. Stroop Test - Digital Cognitive Function Test [Baseline, 75 minutes]

    Changes in Stroop score

  24. Go/No-go Test - Digital Cognitive Function Test [Baseline, 75 minutes]

    Changes in Go/No-go score

  25. Task Switching Task - Digital Cognitive Function Test [Baseline, 75 minutes]

    Changes in Task Switching Task score

  26. Number Back Test - Digital Cognitive Function Test [Baseline, 75 minutes]

    Changes in Number Back Test score

  27. Digit Span Test - Digital Cognitive Function Test [Baseline, 75 minutes]

    Changes in Digit Span Test score

Secondary Outcome Measures

  1. Prefrontal Cortex Oxygenation [Baseline, 90 minutes post ingestion]

    Near-infrared spectroscopy

  2. Peripheral Blood Flow [Baseline, 30, 60 and 90 minutes post ingestion]

    Doppler Ultrasound of Femoral Artery

  3. Peripheral Vascular Conductance [Baseline, 30, 60 and 90 minutes post ingestion]

    Blood flow normalized to blood pressure (mL/min/mmHg)

  4. Blood ketones [Baseline, 30, 60, 90, 120 minutes post ingestion]

    Ketone body level from capillary blood

  5. Blood glucose [Baseline, 30, 60, 90, 120 minutes post ingestion]

    Blood glucose level from capillary blood

  6. Oxygen Consumption from Respiratory Gases [Baseline and continuous for 120 minutes]

    Amount of oxygen consumed using indirect calorimetry

  7. Carbon Dioxide Produced from Respiratory Gases [Baseline and continuous for 120 minutes]

    Amount of carbon dioxide produced using indirect calorimetry

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Southern Mississippi - School of Kinesiology and Nutrition Hattiesburg Mississippi United States 39406

Sponsors and Collaborators

  • University of Southern Mississippi

Investigators

  • Principal Investigator: Austin J Graybeal, PhD, University of Southern Mississippi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Austin Graybeal, Assistant Professor, University of Southern Mississippi
ClinicalTrials.gov Identifier:
NCT05651243
Other Study ID Numbers:
  • 22-877
First Posted:
Dec 14, 2022
Last Update Posted:
Dec 14, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Insulin Resistance
Prediabetic State

Study Results

No Results Posted as of Dec 14, 2022