Clinical trials: Ketones, open to volunteers
Ageing
ICOPE INTENSE-K Pilot Study
ICOPE could constitute the reference model of care for healthy aging. More specifically, our hypothesis is that the intervention implemented in ICOPE may directly or indirectly prevent immuno-senescence, the loss of mobility and…
- Trial name
- NCT07048860
- Testing
- ICOPE intense intervention, Ketone Ester (KE) supplementation, Vitamin D3
- Where
- France
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University Hospital, Toulouse
Ketosis, Metabolic, Immune Functions
The Effect of Acute Exogenous Oral Ketone Supplementation on Immune Cells Function and Immune Cells Histone Β-hydroxybutyrylation
To conduct a single-arm pilot study to determine how acute ingestion of an exogenous ketone monoester supplement alters the histone lysine β-hydroxybutyrylation and immune function in healthy human monocytes and lymphocytes.
- Conditions
- Ketosis, Metabolic, Immune Functions, Histone Deacetylase (HDAC) Activity
- Trial name
- Acute_Ketone (NCT06590623)
- Testing
- Ketone Monoester (KE)
- Where
- Canada
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Knee Osteoarthritis
MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar Design
The purpose of this investigational device exemption (IDE) study is to monitor the performance (safety and efficacy) of the Maxx Orthopedics, Freedom Total Knee® System, with a femoral component of similar design, manufactured…
- Trial name
- NCT06627673
- Testing
- Total Knee Arthroplasty
- Where
- 2 sites in United States
- Volunteers
- 200 people
- Sponsor
- Maxx Orthopedics Inc
Type 1 Diabetes Mellitus, Exercise Physiology
Using a Personalized Decision Support Tool to Help People With Type 1 Diabetes Manage Exercise
This study evaluates a clinician-facing decision-support toolkit designed to assist adults with type 1 diabetes in preparing for moderate-intensity exercise.
- Trial name
- NEXT (NCT07226583)
- Testing
- Standard-of-Care Guidance (SoC), Usual Care (UC), netIOB & Exercise Toolkit (NEXT)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Stanford University
Microbiome Analysis
Comparison of Microbiome Changes in Healthy Adults Following Ketone Ester Consumption
The goal of this observational study is to learn if a ketone ester can improve the content of the gut microbiome. The main questions it aims to answer are: Does a ketone ester reduce age-related signatures in the gut microbiome?…
- Trial name
- BREAK (NCT06954675)
- Testing
- Exogenous ketone ester
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Type 1 Diabetes (T1D)
Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 Diabetes
The goal of this study is to evaluate a CGM-CKM device during insulin suspension in patients with type 1 diabetes. 10 patients with T1D will be recruited for a pilot study. The patients will visit CTRU at Stanford Medical School.
- Trial name
- NCT06977633
- Testing
- Temporary Insulin Suspension, Glucose and ketone sensor
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Mahla Poudineh
Recurrent Glioma (Glioblastoma Multiforme)
GLAD-KE GLioma Biomarker and Safety Assessment During Dietary Ketone Elevation Subtitle: A Surgical Biomarker Discovery Study of Ketogenic Therapy in Recurrent Glioma
This study is being done to see if a Ketogenic Diet (KD) or short-term Ketone supplement (KS) is feasible and safe for patients with recurrent Glioma who are undergoing a clinically indicated surgery.
- Trial name
- GLAD-KE (NCT07852975)
- Testing
- Arm 1 will use Ketone supplement 80 gm daily, Arm 2 will follow Ketogenic Diet 7 days leading up to the clinically indicated surgery.
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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
Prostate Cancer, Prostate Cancer Metastatic
7-Days Water-Only Fasting or Ketone Supplementation Trial in Prostate Cancer
Activating the immune system to kill cancer cells is a promising therapeutic strategy for some patients with cancer. Unfortunately, current immune-targeting treatments do not work for patients with prostate cancer.
- Trial name
- NCT06826924
- Testing
- Fasting, Ketone Supplementation
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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
Nutrition, Ketogenic Diet
Dietary Macronutrients and Gut Microbiota, Inflammation, and Metabolic Markers
This 12-week randomized controlled trial will investigate the effects of dietary patterns with different macronutrient compositions on gut microbiota, intestinal inflammation, gene expression, and metabolic health in healthy…
- Conditions
- Nutrition, Ketogenic Diet, Gene Expression, Diet
- Trial name
- DIETMICRO (NCT07672691)
- Testing
- Ketogenic Diet (KD), Vegetarian Diet (VD), Control Diet (CD)
- Where
- 2 sites in Poland
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- The Jerzy Kukuczka Academy of Physical Education in Katowice
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
Healthy Participants
The Effect of Ketone Monoesters on Skeletal Muscle Protein Synthesis and Whole-body Protein Metabolism.
The ketone β-hydroxybutyrate (BHB) is endogenously produced during periods of low glucose availability, serving as an alternative metabolic fuel.
- Trial name
- WAKM (NCT07082309)
- Testing
- Ketone Monoester (KE) and whey protein beverage, Control
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Exeter
Type 1 Diabetes Mellitus
Evaluating Safe Ketone Thresholds To Minimise Ketosis in People With Type 1 Diabetes Using Dapagliflozin
Sodium glucose cotransporter 2 (SGLT2) inhibitors are a type of medicine that help the kidneys get rid of extra sugar in the blood through urine.
- Trial name
- KETO-TRACK (NCT07225465)
- Testing
- FORXIGA
- Where
- 4 sites in Australia
- Volunteers
- 115 people
- Sponsor
- St Vincent's Hospital Melbourne
Exercise Physiology, Nutritional Supplementation
Effects of Pre-Run Nutritional Supplements During a Fixed-Pace 5 km Treadmill Run
This study will examine how three commonly used pre-run nutritional supplements-caffeine, L-citrulline, and an exogenous ketone supplement-affect physiological and perceptual responses during a fixed-pace 5 km treadmill run in…
- Trial name
- NCT07854223
- Testing
- Caffeine, L-Citrulline, Exogenous Ketone (Beta-Hydroxybutyrate)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- St. Louis University
Acute Heart Failure (AHF)
Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure
This is a multicenter, randomized, double-blind, placebo-controlled trial to investigate the clinical efficacy of treatment with exogenous dietary ketone supplement containing 1,3-butanediol in patients hospitalized with acute…
- Trial name
- KETO-AHF (NCT06653725)
- Testing
- 1,3-butanediol
- Where
- 8 sites in Denmark
- Volunteers
- 250 people
- Sponsor
- Aarhus University Hospital
Alcohol Use Disorder, Alcohol Withdrawal
Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
The goal of this clinical trial is to learn the effects of ketone supplement compared to placebo on alcohol withdrawal symptoms during a 4 day alcohol withdrawal management treatment in adults with moderate to severe alcohol use…
- Conditions
- Alcohol Use Disorder, Alcohol Withdrawal, Ketosis
- Trial name
- KSAW (NCT06559995)
- Testing
- ketone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" 12g of ketones,, magnetic resonance imaging session
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Pennsylvania
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
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
Cognition
Targeted Assessment of Cognition and Tactical-performance With Ingested Ketones
The goal of this study is to determine whether consuming a commercially available exogenous ketone supplement (KetoneIQ®) affects cognition, specifically marksmanship, under physical stress (i.e., exhaustive exercise).
- Trial name
- TACTIK (NCT07771790)
- Testing
- KetoneIQ®
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Florida State University