Skip to main content
OpenTrials
Completed

NCT Number: NCT05651243

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern Mississippi - School of Kinesiology and Nutrition

Hattiesburg, Mississippi, 39406, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketone Ester Supplement

Dietary Supplement

Oral ingestion of a ketone supplement combined with a flavoring agent and diluted in water

Placebo

Other

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

Primary outcomes

  1. Blood pressure

    Time frame: Baseline (pre-ingestion)

    Blood pressure responses (systolic and diastolic) to sympathoexcitation

  2. Blood pressure

    Time frame: 30 minutes post ingestion

    Blood pressure responses (systolic and diastolic) to sympathoexcitation

  3. Blood pressure

    Time frame: 45 minutes post ingestion

    Blood pressure responses (systolic and diastolic) to sympathoexcitation

  4. Blood pressure

    Time frame: 60 minutes post ingestion

    Blood pressure responses (systolic and diastolic) to sympathoexcitation

  5. Blood pressure

    Time frame: 75 minutes post ingestion

    Blood pressure responses (systolic and diastolic) to sympathoexcitation

  6. Blood pressure

    Time frame: 90 minutes post ingestion

    Blood pressure responses (systolic and diastolic) to sympathoexcitation

  7. Blood pressure

    Time frame: 105 minutes post ingestion

    Blood pressure responses (systolic and diastolic) to sympathoexcitation

  8. Heart Rate

    Time frame: Baseline (pre-ingestion)

    Heart rate responses to sympathoexcitation

  9. Heart Rate

    Time frame: 30 minutes post ingestion

    Heart rate responses to sympathoexcitation

  10. Heart Rate

    Time frame: 45 minutes post ingestion

    Heart rate responses to sympathoexcitation

  11. Heart Rate

    Time frame: 60 minutes post ingestion

    Heart rate responses to sympathoexcitation

  12. Heart Rate

    Time frame: 75 minutes post ingestion

    Heart rate responses to sympathoexcitation

  13. Heart Rate

    Time frame: 90 minutes post ingestion

    Heart rate responses to sympathoexcitation

  14. Heart Rate

    Time frame: 105 minutes post ingestion

    Heart rate responses to sympathoexcitation

  15. Heart Rate Variability

    Time frame: Baseline (pre-ingestion)

    Index of cardiac autonomic control

  16. Heart Rate Variability

    Time frame: 45 post ingestion

    Index of cardiac autonomic control

  17. Cardiac Baroreflex Sensitivity

    Time frame: 105 minutes post ingestion

    Changes in cardiac interval relative to changes in systolic blood pressure

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. Stroop Test - Digital Cognitive Function Test

    Time frame: Baseline, 75 minutes

    Changes in Stroop score

  24. Go/No-go Test - Digital Cognitive Function Test

    Time frame: Baseline, 75 minutes

    Changes in Go/No-go score

  25. Task Switching Task - Digital Cognitive Function Test

    Time frame: Baseline, 75 minutes

    Changes in Task Switching Task score

  26. Number Back Test - Digital Cognitive Function Test

    Time frame: Baseline, 75 minutes

    Changes in Number Back Test score

  27. Digit Span Test - Digital Cognitive Function Test

    Time frame: Baseline, 75 minutes

    Changes in Digit Span Test score

Secondary outcomes

  1. Prefrontal Cortex Oxygenation

    Time frame: Baseline, 90 minutes post ingestion

    Near-infrared spectroscopy

  2. Peripheral Blood Flow

    Time frame: Baseline, 30, 60 and 90 minutes post ingestion

    Doppler Ultrasound of Femoral Artery

  3. Peripheral Vascular Conductance

    Time frame: Baseline, 30, 60 and 90 minutes post ingestion

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

  4. Blood ketones

    Time frame: Baseline, 30, 60, 90, 120 minutes post ingestion

    Ketone body level from capillary blood

  5. Blood glucose

    Time frame: Baseline, 30, 60, 90, 120 minutes post ingestion

    Blood glucose level from capillary blood

  6. Oxygen Consumption from Respiratory Gases

    Time frame: Baseline and continuous for 120 minutes

    Amount of oxygen consumed using indirect calorimetry

  7. Carbon Dioxide Produced from Respiratory Gases

    Time frame: Baseline and continuous for 120 minutes

    Amount of carbon dioxide produced using indirect calorimetry

Sponsors and collaborators

Lead sponsor

University of Southern Mississippi

Other

Registry information

Official study title

Non-pharmacological Treatments for Obesity: Leveraging the Appetite Suppressive Effects of Hyperketonemia Through Exogenous Ketone Ingestion to Treat Obesity, Insulin Resistance, and Cognition

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 14, 2022
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.