Clinical trials: Ketogenic Diet
Autism Spectrum Disorder, Autism
Autism Spectrum Disorder (ASD) Neurodevelopmental Disorder With Issues Social Behavior, Communication Issues, GI Dysfunction. Study is Multimodal Interventions Targeting These Pathways With cSVF, Stored MSCs, FMT and Diet Modification. Role of Autoimmunity, Gut-brain Issues, & Issues Examined.
Autism spectrum disorder (ASD) is a neurodevelopmental condition with core deficits in social communication and behavior, often accompanied by gastrointestinal (GI) and metabolic dysfunction.
- Conditions
- Autism Spectrum Disorder, Autism, Autism Spectral Disorder
- Trial name
- GARM-Autism (NCT07546942)
- Testing
- Autologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cells, Fecal Biomicrome Transplantation (FMT), Ketogenic RESET Diet Protocol
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Black Tie Medical, Inc.
Ketogenic Dieting, Epilepsy
Evaluation of Krio in Children and Adults With Epilepsy
Acceptability study to evaluate the gastrointestinal tolerance, palatability and participant compliance, over a 7-day period, of Krio for the dietary management of participants with intractable epilepsy or Glut-1 deficiency…
- Conditions
- Ketogenic Dieting, Epilepsy, Glucose Transporter Type 1 Deficiency Syndrome
- Trial name
- Krio (NCT03202108)
- Testing
- Krio
- Sponsor
- Vitaflo International, Ltd
Migraine, Ketogenic Dieting
Th Effect of Ketogenic Metabolic Nutritional Pattern on High-frequency Episodic Migraine (EMIKETO)
The study aims to investigate the impact of 2 nutritional patterns on high-frequency episodic migraine. Subjects enrolled will be randomized in two arms: a) very-low-calorie-ketogenic-diet (VLCKD), b) hypocaloric balanced non…
- Conditions
- Migraine, Ketogenic Dieting, Weight Loss, Overweight
- Trial name
- EMIKETO (NCT04360148)
- Testing
- very-low-calorie-ketogenic-diet, hypocaloric-balanced-diet
- Where
- Italy
- Volunteers
- 58 people
- Sponsor
- New Penta SRL
Resting Metabolic Rate, Overweight Subjects
A Study to Investigate the Effect of 7-Keto on Resting Metabolic Rate in Overweight Adults
This study will investigate the effect of two different doses of 7-Keto compared to placebo on resting metabolic rate. One third of subjects will be given the lower 7-Keto dose, one third will be given the higher 7-Keto dose and…
- Trial name
- 15KMHI (NCT04782024)
- Testing
- 7-Keto 50mg, 7-Keto 25mg
- Where
- 2 sites in United States
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- KGK Science Inc.
Diabetic Retinopathy (DR), Age-related Macular Degeneration (AMD)
Photobiomodulation & Ketogenic Diet for Treatment of Mid-periphery Retinal Disorders for Alzheimer's Disease Prevention
The study will explore the impact of photobiomodulation (PBM), pulsating at frequencies of red (660nm) and near-infrared (810nm)(NIR), concurrent with a ketogenic dietary protocol (serum ketones @ .5 - 2.0 mmol/L) to mediate…
- Conditions
- Diabetic Retinopathy (DR), Age-related Macular Degeneration (AMD), Mid-peripheral Drusen Formation, Diabetic Macular Edema (DME)
- Trial name
- NCT03859245
- Testing
- Photobiomodulation, Ketogenic diet
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bristlecone Health, Inc.
Diabetic Nephropathy
Controlled Study to Evaluate Efficacy and Safety of α-KA Tab With Low Protein Diet (LPD) in Delaying the Progress of Type 2 Diabetic Nephropathy (DN)
Current expert opinion based consensus guidelines recommend usage of α-Keto analogues of essential amino acids in the diet of diabetic nephropathy patients, along with restricted protein diets.
- Trial name
- NCT00363987
- Testing
- Ketosteril®, diabetic diet
- Where
- China
- Volunteers
- 179 people
- Sponsor
- Fresenius Kabi
Ketosis, Epilepsy
Market Research - Acceptability Study for New MCT Fat Products
This is a market research, observational study to evaluate the tolerability and acceptability of MCT supplements for young children, young people and adults with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood.
- Conditions
- Ketosis, Epilepsy, Fatty Acid Oxidation Disorder, Malabsorption
- Trial name
- NCT04309214
- Testing
- MCT fats
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- Dr. Schär AG / SPA
Polycystic Ovary Syndrome
Combination of D-chiro-inositol With Ketogenic Diet
The study aims to evaluate whether the combination of a product based on D-chiro-inositol and the ketogenic diet can improve the metabolic/endocrine picture of overweight/obese women with PCOS, with insulin resistance, in a…
- Trial name
- NCT05348967
- Testing
- TECADRIOL
- Where
- Italy
- Sponsor
- Lo.Li.Pharma s.r.l
Intractable Epilepsy, Glucose Transporter Type 1 Deficiency Syndrome
Evaluation of Keyo in Children With Epilepsy
To evaluate the tolerance, acceptability and compliance of Keyo in 20 subjects aged 3 years and over, with intractable epilepsy or Glut-1 DS on a KD.
- Conditions
- Intractable Epilepsy, Glucose Transporter Type 1 Deficiency Syndrome, Ketogenic Dieting
- Trial name
- Keyo (NCT02915211)
- Testing
- Keyo
- Where
- 2 sites in United Kingdom
- Volunteers
- 17 people
- Sponsor
- Vitaflo International, Ltd
PTSD
7-Keto DHEA for the Treatment of PTSD
The purpose of this research study is to test the effectiveness of 7-Keto DHEA in reducing symptoms of Post-Traumatic Stress Disorder (PTSD).
- Trial name
- NCT01861847
- Testing
- 7-Keto Dehydroepiandrosterone
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- Humanetics Corporation
Intractable Epilepsy
Ketogenic Diet Drink Study
An evaluation of the tolerance, compliance, acceptability and safety of a nutritionally complete liquid feed for use as part of the ketogenic diet (KD) in children 8+ years, adolescents and adults with intractable epilepsy or…
- Trial name
- NCT03196271
- Testing
- Ketocal 2.5:1
- Where
- 9 sites in United Kingdom
- Volunteers
- 26 people
- Sponsor
- Nutricia UK Ltd
Ketosis, Epilepsy
Market Research - Acceptability Study for a Range of MCT Products
This is a market research, observational study to evaluate the tolerability and acceptability of MCT supplements for young children and young people with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood.
- Conditions
- Ketosis, Epilepsy, Ketogenic Diet, Fatty Acid Oxidation Disorder
- Trial name
- NCT04309149
- Testing
- MCT fats
- Where
- 2 sites in United Kingdom
- Volunteers
- 12 people
- Sponsor
- Dr. Schär AG / SPA
Mild Cognitive Impairment, Metabolic Syndrome
Dietary Ketosis: Fatty Acids Activate AMPK Energy Circuits Modulating Global Methylation
The study explores whether selective memory complaints (SMC), mild cognitive impairment (MCI) and the comorbidity of Metabolic Syndrome symptomatic of peripheral and cerebral hypo-metabolism with corresponding epigenetic shifts…
- Trial name
- NCT03319173
- Testing
- Dietary intervention
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Bristlecone Health, Inc.
Chronic Kidney Disease
Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
The purpose of this study is to characterize the patient and disease profile under the influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA), focusing on the progression of chronic renal…
- Trial name
- NCT02756520
- Testing
- Observational study: Supplemented protein-restricted diet
- Where
- China
- Volunteers
- 154 people
- Sponsor
- Fresenius Kabi
Diabetes Mellitus Type 2 in Obese, Hypertension
Vegetarian Ketogenic Diet VS Omnivore Ketogenic Diet - Protocol of a Keto-vege Diet for Remission of Type 2 Diabetes
Diabetes is one of the biggest public health challenges of the 21st century because of the costs associated with its management, which are estimated at more than three billion dollars per year in Quebec.
- Conditions
- Diabetes Mellitus Type 2 in Obese, Hypertension, Diabetes Mellitus Type 2 With Hyperglycemia, Inflammation
- Trial name
- DT2-OFF (NCT05579561)
- Testing
- Diet
- Where
- Canada
- Volunteers
- 19 people
- Sponsor
- BloomedIn
Overweight, Obesity
The Effect of the Treatment Program "Dr. Fedon Lindbergs Vektcoach" on Body Weight and Composition and Hormonal Profile
The background for the trial is a number of previous studies indicating that it is especially important to restrict the intake of carbohydrates when treating overweight and metabolic diseases in general.
- Conditions
- Overweight, Obesity, Metabolic Syndrome
- Trial name
- NCT01235208
- Testing
- The "Dr. Fedon Lindbergs Vektcoach" Treatment
- Where
- Norway
- Volunteers
- 44 people
- Sponsor
- Eurodiet Scandinavia AS
Drug Resistant Epilepsy, Autism Spectrum Disorder
Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients
The goal of this observational study is to learn about the clinical and nutritional effectiveness of ketogenic diet (KD) in pediatric patients with genetic, neurological or metabolic conditions requiring KD.
- Conditions
- Drug Resistant Epilepsy, Autism Spectrum Disorder, Chronic Migraine, Brain Tumor, Pediatric
- Trial name
- NCT06309251
- Testing
- ketogenic diet (as per clinical practice)
- Where
- 3 sites in Italy
- Volunteers
- 100 people
- Sponsor
- Danone Nutricia SpA Società Benefit
Epilepsy Intractable, Glucose Transporter Type 1 Deficiency Syndrome
Evaluation of Ketoflo
For 28 days, 30 participants aged 3 to 18 years of age (inclusive) with a condition requiring a ketogenic diet will incorporate Ketoflo into their usual dietary regime.
- Conditions
- Epilepsy Intractable, Glucose Transporter Type 1 Deficiency Syndrome, Ketogenic Dieting
- Trial name
- Ketoflo (NCT04399954)
- Testing
- Ketoflo
- Where
- 5 sites in United Kingdom
- Volunteers
- 25 people
- Sponsor
- Vitaflo International, Ltd
Renal Insufficiency, Chronic
Short-term Metabolic Effects of Ketosteril® Supplemented Low Protein Diet in Pre-dialysis Chronic Kidney Disease (CKD) Patients
Supplementation of ketoanalogues of essential amino acids improves the protein quality of protein restricted diets without burdening the kidneys.
- Trial name
- CKD (NCT03077048)
- Testing
- Ketosteril®
- Where
- Czechia
- Volunteers
- 23 people
- Sponsor
- Fresenius Kabi
Deficiency of Micronutrients
Evaluation of ZestiVits in Children and Adults on a Ketogenic or Restricted Therapeutic Diet
A study to evaluate the acceptability of ZestiVits; a new vitamin, mineral and trace element supplement for children aged 11 years and over and adults on a ketogenic or restricted therapeutic diet with regard to product…
- Trial name
- ZestiVits (NCT02825758)
- Testing
- ZestiVits
- Where
- 3 sites in United Kingdom
- Volunteers
- 15 people
- Sponsor
- Vitaflo International, Ltd