Clinical trials: Diet Therapy
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
Drug Resistant Epilepsy, Ketogenic Dieting
Management of Drug-resistant Epilepsy in Infants and Children: a Real-life Study of the Use of the Ketogenic Diet in France and the KetoCal® Range in Its Maintenance
This is a multicenter, prospective, observational, longitudinal study designed to describe the therapeutic value of the KetoCal® range in the maintenance of a ketogenic diet during the management of infants (from 5 months) and…
- Trial name
- KEOPS (NCT06075485)
- Testing
- Ketocal
- Where
- France
- Volunteers
- 133 people
- Sponsor
- Nutricia Nutrition Clinique
Eosinophilic Esophagitis (EoE)
Trial of Partial Enteral Nutrition With Dairy Free Diet in Eosinophilic Esophagitis
This study aims to introduce a new dietary therapy for Eosinophilic Esophagitis (EoE) patients by using partial enteral nutrition (PEN) to enhance remission rates and explore how this approach affects immune function, gut…
- Trial name
- NCT07234825
- Testing
- Partial enteral nutrition (PEN) with dairy elimination, Dairy elimination alone
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Kate Farms Inc
Infections on, Severe Burn Patients
Effect of Early Enteral Tube Feeding Nutrition With an Immune Enhancing Diet in Severe Burn Patients
Compare clinical and biological effects of two enteral tube feeding nutrition formula (immune enhancing diet versus polymeric diet)in severe burn hospitalized patients .
- Trial name
- NCT00561210
- Testing
- Crucial, Sondalis HP
- Where
- 5 sites in France
- Volunteers
- 57 people
- Sponsor
- Société des Produits Nestlé (SPN)
Phenylketonuria
Kuvan® in Phenylketonuria Patients Less Than 4 Years Old
This is a Phase 3b, multicenter, open-label, randomized, controlled study to evaluate efficacy, safety and population pharmacokinetics of sapropterin dihydrochloride (Kuvan®) in less than 4 year-old infants and children with…
- Trial name
- SPARK (NCT01376908)
- Testing
- Kuvan®, Phenylalanine (Phe)-restricted diet
- Where
- 22 sites in Austria, Belgium and 7 more
- Volunteers
- 56 people
- Sponsor
- BioMarin Pharmaceutical
Growth and Tolerance Infant Study
Nutritional Management of Infants With Chronic Diarrhea
The study objective is to assess the growth of infants fed an experimental formula for the nutritional management of chronic diarrhea.
- Trial name
- NCT01820494
- Testing
- Experimental Infant Formula
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- Abbott Nutrition
Enteral Nutrition
Study to Evaluate the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG)
This is a Multicenter, Open-label, Single-arm study evaluating the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG) in the Nutritional Management of Tube-fed Children Aged 1-4…
- Trial name
- NCT04516213
- Testing
- Enteral Formula With (PHGG)
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Société des Produits Nestlé (SPN)
Child Development, Diet, Healthy
Prebiotic Effects in Healthy Toddlers
The aim of this study is to demonstrate that a dietary supplementation with a novel prebiotic combination is safe, well tolerated and able to improve overall health of toddlers.
- Trial name
- PrebiKidz (NCT05783141)
- Testing
- New prebiotic follow-on formula, randomly assigned to healthy toddlers, Standard follow-on formula, randomly assigned to healthy toddlers
- Where
- Belgium
- Volunteers
- 342 people, healthy volunteers welcome
- Sponsor
- Beneo-Institute
Breast Milk Collection
Human Milk Sample Composition in Israeli Mothers and Correlation With Their Diet
The study will collect human milk from 100 mother of term infants 2-3m after delivery and from 50 mothers of preterm infants 14 and 30 days after delivery.
- Trial name
- NCT02596295
- Where
- Israel
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Enzymotec
Obesity
Cities for Better Health Childhood Obesity Prevention Initiative
This research project is part of the 'Cities for Better Health Childhood Obesity Prevention Initiative' (CBH COPI). The objective of the CBH COPI initiative is to develop, implement, and evaluate the effectiveness of a package of…
- Trial name
- CBH COPI (NCT06855563)
- Testing
- Community-based intervention packages
- Where
- 6 sites in Australia, Brazil and 4 more
- Volunteers
- 36,000 people
- Sponsor
- Novo Nordisk A/S
Stroke, Relatives
Survey of Lifelong Food and Nutrition Assistance (LIFANA) in Stroke Patients and Caregivers
Many elderly suffer from nutritional problems that can cause (or can be caused by) a number of complications such as weakened immune systems and chronic health conditions (diabetes type 2, high blood pressure, cardiovascular…
- Conditions
- Stroke, Relatives, Diet Modification
- Trial name
- NCT03635476
- Testing
- Qualitative interview study
- Where
- Switzerland
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Cereneo AG
Infectious Disease, Children, Only
Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children
The study aims to explore whether prophylactic dietary supplementation with prebiotic inulin-type fructans is able to influence the intestinal microbiota and the frequency of infectious disease episodes in kindergarten children…
- Conditions
- Infectious Disease, Children, Only, Diet Modification
- Trial name
- NCT03241355
- Testing
- prebiotic inulin-type fructan
- Volunteers
- 258 people, healthy volunteers welcome
- Sponsor
- Beneo-Institute
Diabetes, Diabetes Mellitus, Type 2
A Trial Investigating the Efficacy and Safety of Insulin Detemir Versus Insulin NPH in Combination With Metformin and Diet/Exercise in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on Metformin With or Without Other Oral Antidiabetic Drug(s) With or Without Basal Insulin
This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of insulin detemir versus insulin Neutral Protamine Hagedorn (NPH) in combination with the maximum tolerated dose of metformin and…
- Trial name
- iDEAt2 (NCT02131272)
- Testing
- Insulin detemir, Insulin NPH, Diet/exercise
- Where
- 82 sites in United States, Argentina and 22 more
- Volunteers
- 42 people
- Sponsor
- Novo Nordisk A/S
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.
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
Infant Development, Healthy
Prebiotic EffecT InfanTs
The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on stool consistency in infants.
- Conditions
- Infant Development, Healthy, Diet, Healthy
- Trial name
- PETIT (NCT04791956)
- Testing
- Prebiotic
- Where
- 2 sites in Spain
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Beneo-Institute
Migraine
Influence of a Dietary Supplement as Treatment of Migraine in Children and Adolescents
Migraine in children and adolescents can be associated with low serum levels of coenzyme q10, the key-enzyme of mitochondrial energy production.During migraine attacks inflammation is an important issue.
- Trial name
- NCT01010711
- Testing
- Migra 3
- Where
- 2 sites in Germany
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Complen Health GmbH
Phenylketonuria (PKU)
Study to Evaluate the Safety and Efficacy of Pegvaliase in Adolescents (Ages 12-17) With Phenylketonuria
This is a Phase 3 open-label randomized controlled study enrolling approximately 54 adolescents with PKU. The study is designed to assess the safety and efficacy of pegvaliase injections.
- Trial name
- PEGASUS (NCT05270837)
- Testing
- Pegvaliase, Diet Only
- Where
- 16 sites in United States, Germany
- Volunteers
- 55 people
- Sponsor
- BioMarin Pharmaceutical
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
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