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Recruiting NCT05651243

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

Conditions: Obesity, Pre Diabetes, Diabetes Mellitus, Type 2, Insulin Resistance

Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 30
Sponsor: University of Southern Mississippi

Location: United States

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,metabolismcardiovascular functionResearchers 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.

Eligibility Criteria

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 femalesBody 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 prediabetesFasting blood glucose of 126 mg/dl or greater indicating undiagnosed diabetesPreviously 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, andNo indication of diabetes based on the aforementioned criteriaExclusion Criteria:PregnantBreastfeeding or lactatingMissing any limbs or part of a limbHaving a substantial amount of metal implants (metal plates or complete joint replacements)Having a pacemaker or any other electrical implantType I diabetesGestational diabetesTaking insulinAny history of severe traumatic brain injury or mild traumatic brain injury within the last two yearsKidney diseaseLiver diseaseThyroid diseaseAny diagnosed neurological or neurodegenerative diseasesAny surgeries that would impact swallowing and/or digestionBeing on a ketogenic diet or having been on a ketogenic diet in the last 6 monthsHaving received ionizing radiation from a medical procedure within the last 30 daysBeing on a medically prescribed diet

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05651243). StuddyBuddy aggregates publicly available trial information.