Metabolic SyndromeNCT05651243
Ketone Esters for Appetite, Cognition, and Cardiovascular Function in Individuals With Obesity and Insulin Resistance
A study testing Ketone Ester Supplement in people with Metabolic Syndrome, run by University of Southern Mississippi at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Ketone Ester Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2022to 29 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern Mississippi - School of Kinesiology and Nutrition
Hattiesburg, Mississippi, 39406
About this study
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
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:
Read more
- 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Ketone Ester Supplement, Placebo
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone Ester SupplementDietary supplement
Oral ingestion of a ketone supplement combined with a flavoring agent and diluted in water
PlaceboOther
Oral ingestion of cellulose combined with a flavoring agent and diluted in water
| Study group | Role | What they receive |
|---|---|---|
| Ketone Ester | Experimental | Oral ketone ester supplement Receives: Dietary Supplement: Ketone Ester Supplement |
| Placebo | Placebo comparator | Taste and viscosity matched placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Measured: Baseline (pre-ingestion)
Blood pressure
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Measured: 30 minutes post ingestion
Blood pressure
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Measured: 45 minutes post ingestion
Blood pressure
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Measured: 60 minutes post ingestion
Blood pressure
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Measured: 75 minutes post ingestion
Blood pressure
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Measured: 90 minutes post ingestion
Blood pressure
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Measured: 105 minutes post ingestion
Heart Rate
Heart rate responses to sympathoexcitation
Measured: Baseline (pre-ingestion)
Heart Rate
Heart rate responses to sympathoexcitation
Measured: 30 minutes post ingestion
Heart Rate
Heart rate responses to sympathoexcitation
Measured: 45 minutes post ingestion
Heart Rate
Heart rate responses to sympathoexcitation
Measured: 60 minutes post ingestion
Heart Rate
Heart rate responses to sympathoexcitation
Measured: 75 minutes post ingestion
Heart Rate
Heart rate responses to sympathoexcitation
Measured: 90 minutes post ingestion
Heart Rate
Heart rate responses to sympathoexcitation
Measured: 105 minutes post ingestion
Heart Rate Variability
Index of cardiac autonomic control
Measured: Baseline (pre-ingestion)
Heart Rate Variability
Index of cardiac autonomic control
Measured: 45 post ingestion
Cardiac Baroreflex Sensitivity
Changes in cardiac interval relative to changes in systolic blood pressure
Measured: 105 minutes post ingestion
Hunger - Visual Digital Analog Scale (0-100)
Changes in subjective rating of hunger
Measured: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Fullness - Visual Digital Analog Scale (0-100)
Changes in subjective rating of fullness
Measured: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Desire to eat - Visual Digital Analog Scale (0-100)
Changes in subjective rating of desire to eat
Measured: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Prospective consumption of food - Visual Digital Analog Scale (0-100)
Changes in subjective rating of prospective consumption of food
Measured: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Thirst - Visual Digital Analog Scale (0-100)
Changes in subjective rating of thirst
Measured: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Stroop Test - Digital Cognitive Function Test
Changes in Stroop score
Measured: Baseline, 75 minutes
Go/No-go Test - Digital Cognitive Function Test
Changes in Go/No-go score
Measured: Baseline, 75 minutes
Task Switching Task - Digital Cognitive Function Test
Changes in Task Switching Task score
Measured: Baseline, 75 minutes
Number Back Test - Digital Cognitive Function Test
Changes in Number Back Test score
Measured: Baseline, 75 minutes
Digit Span Test - Digital Cognitive Function Test
Changes in Digit Span Test score
Measured: Baseline, 75 minutes
Secondary outcomes (7)
Prefrontal Cortex Oxygenation
Near-infrared spectroscopy
Measured: Baseline, 90 minutes post ingestion
Peripheral Blood Flow
Doppler Ultrasound of Femoral Artery
Measured: Baseline, 30, 60 and 90 minutes post ingestion
Peripheral Vascular Conductance
Blood flow normalized to blood pressure (mL/min/mmHg)
Measured: Baseline, 30, 60 and 90 minutes post ingestion
Blood ketones
Ketone body level from capillary blood
Measured: Baseline, 30, 60, 90, 120 minutes post ingestion
Blood glucose
Blood glucose level from capillary blood
Measured: Baseline, 30, 60, 90, 120 minutes post ingestion
Oxygen Consumption from Respiratory Gases
Amount of oxygen consumed using indirect calorimetry
Measured: Baseline and continuous for 120 minutes
Carbon Dioxide Produced from Respiratory Gases
Amount of carbon dioxide produced using indirect calorimetry
Measured: Baseline and continuous for 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start28 Dec 2022
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Mississippi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Austin Graybeal, University of Southern Mississippi
- Investigators
- Austin J Graybeal, PhD, Principal investigator, University of Southern Mississippi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651243
- Sponsor's protocol ID
- 22-877
- Status last verified
- May 2024
- First submitted
- 3 Nov 2022
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stavres J, Aultman RS, Brandner CF, Vallecillo-Bustos A, Compton AT, Swafford SH, Newsome TA, Graybeal AJ. Influence of exogenous ketosis on spontaneous cardiovagal baroreflex gain and blood pressure responses to isometric handgrip in individuals with metabolic syndrome: a placebo-controlled pilot study. Eur J Appl Physiol. 2026 Jan;126(1):549-562. doi: 10.1007/s00421-025-05921-z. Epub 2025 Jul 31.
PubMed 40745496
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05651243
- Acronym / sponsor ID
- 22-877
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Southern MississippiUniversity, hospital or other
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketone Ester | Experimental | Dietary Supplement: Ketone Ester SupplementOral ketone ester supplement |
| Placebo | Placebo comparator | Other: PlaceboTaste and viscosity matched placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults between the ages of 18-50 years of age.
- Presence of metabolic sydnrome
- A waist circumference of < 102 cm for males and < 88 cm for females, and
- No indication of metabolic syndrome
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketone Ester SupplementOral ingestion of a ketone supplement combined with a flavoring agent and diluted in water | Dietary supplement | Ketone Ester |
| PlaceboOral ingestion of cellulose combined with a flavoring agent and diluted in water | Other | Placebo |
Primary outcome
Blood pressure
Time frame: Baseline (pre-ingestion)
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Blood pressure
Time frame: 30 minutes post ingestion
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Blood pressure
Time frame: 45 minutes post ingestion
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Blood pressure
Time frame: 60 minutes post ingestion
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Blood pressure
Time frame: 75 minutes post ingestion
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Blood pressure
Time frame: 90 minutes post ingestion
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Blood pressure
Time frame: 105 minutes post ingestion
Blood pressure responses (systolic and diastolic) to sympathoexcitation
Heart Rate
Time frame: Baseline (pre-ingestion)
Heart rate responses to sympathoexcitation
Heart Rate
Time frame: 30 minutes post ingestion
Heart rate responses to sympathoexcitation
Heart Rate
Time frame: 45 minutes post ingestion
Heart rate responses to sympathoexcitation
Heart Rate
Time frame: 60 minutes post ingestion
Heart rate responses to sympathoexcitation
Heart Rate
Time frame: 75 minutes post ingestion
Heart rate responses to sympathoexcitation
Heart Rate
Time frame: 90 minutes post ingestion
Heart rate responses to sympathoexcitation
Heart Rate
Time frame: 105 minutes post ingestion
Heart rate responses to sympathoexcitation
Heart Rate Variability
Time frame: Baseline (pre-ingestion)
Index of cardiac autonomic control
Heart Rate Variability
Time frame: 45 post ingestion
Index of cardiac autonomic control
Cardiac Baroreflex Sensitivity
Time frame: 105 minutes post ingestion
Changes in cardiac interval relative to changes in systolic blood pressure
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
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
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
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
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
Stroop Test - Digital Cognitive Function Test
Time frame: Baseline, 75 minutes
Changes in Stroop score
Go/No-go Test - Digital Cognitive Function Test
Time frame: Baseline, 75 minutes
Changes in Go/No-go score
Task Switching Task - Digital Cognitive Function Test
Time frame: Baseline, 75 minutes
Changes in Task Switching Task score
Number Back Test - Digital Cognitive Function Test
Time frame: Baseline, 75 minutes
Changes in Number Back Test score
Digit Span Test - Digital Cognitive Function Test
Time frame: Baseline, 75 minutes
Changes in Digit Span Test score
7 secondary outcomes
Prefrontal Cortex Oxygenation
Time frame: Baseline, 90 minutes post ingestion
Peripheral Blood Flow
Time frame: Baseline, 30, 60 and 90 minutes post ingestion
Peripheral Vascular Conductance
Time frame: Baseline, 30, 60 and 90 minutes post ingestion
Blood ketones
Time frame: Baseline, 30, 60, 90, 120 minutes post ingestion
Blood glucose
Time frame: Baseline, 30, 60, 90, 120 minutes post ingestion
Oxygen Consumption from Respiratory Gases
Time frame: Baseline and continuous for 120 minutes
Carbon Dioxide Produced from Respiratory Gases
Time frame: Baseline and continuous for 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Derived from this study: PubMed 40745496Stavres J, Aultman RS, Brandner CF, Vallecillo-Bustos A, Compton AT, Swafford SH, Newsome TA, Graybeal AJ. Influence of exogenous ketosis on spontaneous cardiovagal baroreflex gain and blood pressure responses to isometric handgrip in individuals with metabolic syndrome: a placebo-controlled pilot study. Eur J Appl Physiol. 2026 Jan;126(1):549-562. doi: 10.1007/s00421-025-05921-z. Epub 2025 Jul 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Austin J Graybeal, PhD principal investigator
University of Southern Mississippi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone Ester Supplement in people with Metabolic Syndrome, run by University of Southern Mississippi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Baseline (pre-ingestion)). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05651243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.