Ketone Ester for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Obesity+3 MoreKetone Ester Supplement - DietarySupplement
Eligibility
18 - 50
All Sexes
What conditions do you have?
Select

Study 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, 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.

Eligible Conditions
  • Obesity
  • Insulin Resistance
  • Prediabetes
  • Type 2 Diabetes

Treatment Effectiveness

Study Objectives

14 Primary · 7 Secondary · Reporting Duration: Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion

105 minutes post ingestion
Blood pressure
Cardiac Baroreflex Sensitivity
Heart Rate
45 post ingestion
Heart Rate Variability
Baseline and continuous for 120 minutes
Carbon Dioxide Produced from Respiratory Gases
Oxygen Consumption from Respiratory Gases
Baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion
Desire to eat - Visual Digital Analog Scale (0-100)
Fullness - Visual Digital Analog Scale (0-100)
Hunger - Visual Digital Analog Scale (0-100)
Prospective consumption of food - Visual Digital Analog Scale (0-100)
Thirst - Visual Digital Analog Scale (0-100)
Baseline, 30, 60 and 90 minutes post ingestion
Peripheral Blood Flow
Peripheral Vascular Conductance
Baseline, 30, 60, 90, 120 minutes post ingestion
Blood glucose
Blood ketones
Baseline, 75 minutes
Digit Span Test - Digital Cognitive Function Test
Go/No-go Test - Digital Cognitive Function Test
Number Back Test - Digital Cognitive Function Test
Stroop Test - Digital Cognitive Function Test
Task Switching Task - Digital Cognitive Function Test
Baseline, 90 minutes post ingestion
Prefrontal Cortex Oxygenation

Trial Safety

Trial Design

2 Treatment Groups

Ketone Ester
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: Ketone Ester · Has Placebo Group · N/A

Ketone Ester
DietarySupplement
Experimental Group · 1 Intervention: Ketone Ester Supplement · Intervention Types: DietarySupplement
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 30, 45, 60, 75, 90, 105, 120 minutes post ingestion

Who is running the clinical trial?

University of Southern MississippiLead Sponsor
10 Previous Clinical Trials
3,009 Total Patients Enrolled
2 Trials studying Obesity
431 Patients Enrolled for Obesity
Austin J Graybeal, PhDPrincipal InvestigatorUniversity of Southern Mississippi

Eligibility Criteria

Age 18 - 50 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between the ages of 18-50 years old.
Your BMI is 30 kg/m2 or greater and waist circumference exceeds 102 cm for males and 88 cm for females.
Males must have a body fat percentage of 28% or lower, while females must have a body fat percentage of 40% or lower.
Your fasting blood glucose level is between 100-125 mg/dl, indicating prediabetes.
Your fasting blood glucose level is at least 126 milligrams per decilitre, indicating that you may have undiagnosed diabetes.
You have been diagnosed with non-insulin dependent type II diabetes.
You have a normal body mass index (BMI) of less than 25.00 kg/m2.
Males must have a waist circumference of less than 102 cm, and females must have a waist circumference of less than 88 cm.
No signs of diabetes are present according to the pre-defined criteria.