Clinical trials: Ketosis, open to volunteers
Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)
Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.
The goal of this clinical trial is to develop and evaluate a novel diabetes ketoacidosis risk mitigation strategy to support the safe use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy in participants with type 1…
- Conditions
- Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM), Chronic Kidney Disease, Diabetic Ketoacidosis
- Trial name
- SCOUT-CKD (NCT07325201)
- Testing
- Sotagliflozin initiation
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- HealthPartners Institute
Post-exercise Period, Ketosis
Acute Effects of Ketone Monoester Co-ingestion With Dietary Protein on Whole-body Phenylalanine Oxidation, Phenylalanine Retention, and Myofibrillar Protein Breakdown Following Resistance Exercise in Young Males.
The goal of this trial is to determine if ketone monoester supplementation in conjunction with protein supplementation in the post exercise period can augment whole-body protein metabolism following resistance exercise in young…
- Conditions
- Post-exercise Period, Ketosis, Resistance Exercise, Dietary Protein
- Trial name
- (KET-YOUNG-M) (NCT07884539)
- Testing
- Ketone Monoester + Dietary Protein (KET+PRO), Dietary Protein (PRO), Resistance Exercise
- Where
- Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- McGill University
Nutritional and Metabolic Diseases, Prediabetes
LIfestyle MEtabotype Study B (LIME-B)
Glycemic responses vary significantly among individuals, even when consuming identical foods or meals, but the factors predicting individual glucose responses to food intake remain poorly investigated.
- Conditions
- Nutritional and Metabolic Diseases, Prediabetes, Type 2 Diabetes
- Trial name
- LIME-B (NCT07888257)
- Testing
- βHB drink (ketone ester), Carbohydrate drink
- Where
- 2 sites in Germany
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- German Institute of Human Nutrition
Alcohol Use Disorder, Ketosis
Effects of Ketones on Brain Energetics and Alcohol Consumption in Alcohol Use Disorder
This is a randomized, double-blind, crossover trial to evaluate the immediate effects of a nutritional ketone supplement, Kenotic compared to placebo on brain function and alcohol consumption in individuals with alcohol use…
- Trial name
- KABA (NCT06807918)
- Testing
- Kenetik, magnetic resonance imaging scan, Alcohol bar lab
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Pennsylvania
Ketosis, Resistance Exercise
Acute Effects of Ketone Monoester Co-Ingestion With Dietary Protein on Whole-Body Phenylalanine Oxidation, Phenylalanine Retention, and Myofibrillar Protein Breakdown Following Resistance Exercise in Older Males
The goal of this trial is to determine if ketone monoester supplementation in conjunction with protein supplementation in the post exercise period can augment whole-body protein metabolism following resistance exercise in older…
- Conditions
- Ketosis, Resistance Exercise, Dietary Protein, Aging
- Trial name
- KET-OLD-M (NCT07884513)
- Testing
- Ketone Monoester + Dietary Protein (KET+PRO), Dietary Protein (PRO), Resistance Exercise
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- McGill University
Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Normal Ejection Fraction
Chronic Exogenous Ketosis in HFpEF
The goal of this clinical research study is to test what effects a ketone drink will have in people with heart failure with preserved ejection fraction (HFpEF), including on exercise and heart function.
- Conditions
- Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Normal Ejection Fraction, Heart Failure, Diastolic
- Trial name
- NCT06937320
- Testing
- Exogenous Ketone Drink
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Duke University
Fasting, Dietary Fibre
Combining Fasting and Fibre Interventions to Optimise Their Gut Microbiome-mediated Health Benefits
This study builds on the knowledge that fasting provides metabolic health benefits and that prebiotic interventions can enhance the gut microbiome's metabolic output to likewise improve host health.
- Conditions
- Fasting, Dietary Fibre, Gut Microbiome, Metabolism Changes
- Trial name
- CoFFIe (NCT07691736)
- Testing
- Fibre Arm, Control Arm
- Where
- Germany
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Buchinger Wilhelmi Development & Holding GmbH
Critical Illness, Fasting State
Ketosis, Immune Function and Metabolic Adaptation in Response to Short-term Fasting in Critical Illness
KETO-FAST is a pre-planned translational substudy of the FAST-ICU cluster-randomized cross-over trial. The substudy will characterize ketone body production and associated metabolic, autophagy-related, and immune cellular…
- Conditions
- Critical Illness, Fasting State, Ketosis, Nutrition
- Trial name
- KETO-FAST (NCT07738536)
- Testing
- Delayed nutrition, Standard nutrition, Fasting
- Where
- Sweden
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Karolinska University Hospital
Athletic Performance, Exercise
Endurance Trial: Ketone and Carbohydrate Supplementation
This randomized, double-blind, crossover study investigates the effects of exogenous ketone supplementation on physical and cognitive performance in amateur endurance athletes during exhaustive exercise.
- Conditions
- Athletic Performance, Exercise, Ketosis, Cognition
- Trial name
- NCT07792876
- Testing
- Carbohydrate beverage, (R)-1,3-butanediol, Standardized evening meal
- Where
- Brazil
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Opioid Use Disorder
Ketones for Opioid Craving
The goal of this clinical trial is to learn if ketone supplementation (KS) works to reduce craving for opioids for adults with opioid use disorder (OUD) undergoing in-patient acute withdrawal management.
- Trial name
- NCT07128524
- Testing
- Treatment with Ketone Supplement
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Maryland, Baltimore
ICU Delirium, Critical Illness
Exogenous Ketone Supplementation in ICU Delirium
Delirium is a common syndrome in intensive care unit (ICU) patients. Those experiencing delirium may suddenly feel confused, have trouble thinking clearly, struggle to pay attention, or see and hear things that are not real.
- Trial name
- KETONES-ICU (NCT07364162)
- Testing
- Ketone monoester
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Vanderbilt University Medical Center
Ketosis Prone Diabetes
Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity
The goal of this study is to quantify day-to-day changes in blood glucose during treatment towards remission in ketosis-prone diabetes (KPDM) and describe them using a mathematical model of KPDM pathogenesis and remission.
- Trial name
- NCT06699810
- Testing
- Continuous Glucose Monitoring, Insulin
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Emory University
First Episode Psychosis
Recovery With Exogenous Ketones and Antipsychotics
The RECAP project will evaluate the clinical and metabolic effects of adding exogenous ketones to antipsychotic (AP) treatment in young adults with a first episode of psychosis (FEP).
- Trial name
- RECAP (NCT07122531)
- Testing
- Medium chain triglyceride oil
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- Université de Sherbrooke
Ketosis
Variations in Ketone Metabolism
This outcome of this study will elucidate how the phenotype of the individual modulates the KE metabolic effect. Most studies of KE have been in homogenous populations, usually young, male athletes.
- Trial name
- STAK-VKM (NCT05924295)
- Testing
- Ketone Supplement, Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale, Blood Draw
- Where
- 2 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Ohio State University
Metabolic Diseases, Diabetes Mellitus (Type 2)
Specificities of Atypical Non AutoImmune Diabetes (ANAID) in the French West Indies
Genetics variants could be involved in atypical non-autoimmune diabetes revealed by ketoacidosis. The objective of this research will be to determine the relationships between the genetic variants already described in known…
- Conditions
- Metabolic Diseases, Diabetes Mellitus (Type 2), Genetic Variation, Genetic Profile
- Trial name
- DiAGeNA (NCT07576374)
- Where
- Guadeloupe
- Volunteers
- 118 people
- Sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
Acute Heart Failure (AHF), Cardiogenic Shock
Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure
This study will evaluate the feasibility and safety of achieving therapeutic concentrations of beta-hydroxybutyrate using continuous infusion of D-beta-hydroxybutyrate monoester administered via a nasogastric tube in patients…
- Conditions
- Acute Heart Failure (AHF), Cardiogenic Shock, Heart Failure, Ketones
- Trial name
- KADHEF-2 (NCT07527156)
- Testing
- Ketone Monoester (KE)
- Where
- Czechia
- Volunteers
- 12 people
- Sponsor
- Institute for Clinical and Experimental Medicine
Type2 Diabetes, Heart Failure With Preserved Ejection Fraction
SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
The study team will examine the effects of SGLT2i (and SGLT2i-induced increases in plasma ketone concentrations) on skeletal muscle and cardiac ketone uptake, skeletal muscle bioenergetics, cardiopulmonary exercise capacity, and…
- Trial name
- NCT05057806
- Testing
- Empagliflozin 25 MG
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
Alcohol Use Disorder, Alcohol Withdrawal
Effects of Ketone Supplementation on Acute Alcohol Withdrawal
The goal of this study is to study the effects of the ketone supplement Kenetik compared to placebo (an inactive beverage) on alcohol withdrawal symptoms during the 5 days of clinical alcohol withdrawal management treatment at…
- Conditions
- Alcohol Use Disorder, Alcohol Withdrawal, Alcohol Dependence, Ketosis
- Trial name
- NCT06173973
- Testing
- Kenetik; Ketone Concentrate
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of Pennsylvania
Type 2 Diabetes, Ketone Body Metabolism
Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function
This study is being done to evaluate how a ketone ester (KE) supplement affects heart function and health in people with diabetes compared to a placebo supplement (made with standard food ingredients that do not contain ketone…
- Conditions
- Type 2 Diabetes, Ketone Body Metabolism, Ketones, Metabolism
- Trial name
- NCT06078683
- Testing
- Ketone Ester Acute
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Ohio State University
Sepsis Induced Cardiomyopathy
Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection and is associated with a high mortality rate in the ICU.
- Trial name
- KetoSIC (NCT06952140)
- Testing
- Ketone ester
- Volunteers
- 12 people
- Sponsor
- Tor Biering-Sørensen