NCT05651243Completed
Ketone Esters for Appetite, Cognition, and Cardiovascular Function in Individuals With Obesity and Insulin Resistance
Non-pharmacological Treatments for Obesity: Leveraging the Appetite Suppressive Effects of Hyperketonemia Through Exogenous Ketone Ingestion to Treat Obesity, Insulin Resistance, and Cognition
Source: ClinicalTrials.gov · Last updated 22 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 3 Nov 2022
- Start date
- 28 Dec 2022
- Primary completion date
- 29 Dec 2023
- Lead sponsor
- University of Southern Mississippi
- Diseases
- Obesity
- NCT number
- NCT05651243
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 28 Dec 2022 to the primary completion date, 29 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having a substantial amount of metal implants (metal plates or complete joint replacements)
- Having a pacemaker or any other electrical implant
- Having received ionizing radiation from a medical procedure within the last 30 days
Other illness
- Type I diabetes
- Gestational diabetes
- 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
Other
- Pregnant
- Breastfeeding or lactating
- Missing any limbs or part of a limb
- Taking insulin
- 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
- Being on a medically prescribed diet
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Southern Mississippi - School of Kinesiology and Nutrition Coordinator of this site? Confirm its status | Hattiesburg | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.