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

NCT ID: NCT05651243

Last Updated: 2024-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-28

Study Completion Date

2023-12-29

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ketone Ester

Oral ketone ester supplement

Group Type EXPERIMENTAL

Ketone Ester Supplement

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Taste and viscosity matched placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Ketone Ester Supplement

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern Mississippi

OTHER

Sponsor Role lead

Responsible Party

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Austin Graybeal

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Austin J Graybeal, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern Mississippi

Locations

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University of Southern Mississippi - School of Kinesiology and Nutrition

Hattiesburg, Mississippi, United States

Site Status

Countries

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United States

References

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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. 2025 Jul 31. doi: 10.1007/s00421-025-05921-z. Online ahead of print.

Reference Type DERIVED
PMID: 40745496 (View on PubMed)

Other Identifiers

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22-877

Identifier Type: -

Identifier Source: org_study_id

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