Clinical trials: Food Effect
Cytomegalovirus Infections, HIV Infections
A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir
This study is designed to determine the influence of food on the absorption and relative bioavailability of oral ganciclovir by comparing the absorption of oral ganciclovir in a fed and fasting state at steady state plasma levels.
- Trial name
- NCT00002251
- Testing
- Ganciclovir
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Hoffmann-La Roche
Healthy
A Study of a Probiotic Food Supplement Containing B. Infantis (EVC001) in Healthy Breastfed Infants at Risk of Developing Atopic Dermatitis
The purpose of this study is to assess the effect of B. infantis (EVC001) versus placebo supplementation, in healthy breastfed infants at risk of developing atopic dermatitis (AD), on cumulative incidence of physician-diagnosed…
- Trial name
- NCT04662619
- Testing
- B. infantis
- Where
- Finland
- Volunteers
- 273 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
Neurofibromatosis Type 1
Phase I Study to Assess the Effect of Food on the PK and Gastrointestinal Tolerability of Selumetinib in Adolescent Children With Neurofibromatosis Type 1 Related Plexiform Neurofibromas
This study in adolescent participants with NF1 who have inoperable PN is designed to evaluate the effect of a low fat meal on steady state selumetinib exposure; to assess the effect on GI tolerability when selumetinib is dosed…
- Trial name
- NCT05101148
- Testing
- Selumetinib
- Where
- 9 sites in United States, Poland and 2 more
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
Pyridoxine Dependant Epilepsy
Evaluation of PDE MAX
PDE MAX is a single arm prospective, feasibility study in up to 15 participants aged one (1) year and over of PDE MAX for the dietary management of Pyridoxine Dependent Epilepsy.
- Trial name
- PDE MAX (NCT04672226)
- Testing
- PDE MAX
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 11 people
- Sponsor
- Vitaflo International, Ltd
Allergy, Food Allergy
An Elimination Diet Using a New Amino Acid Based Formula: Immunological and Clinical Effects in Cow's Milk Allergy
The purpose of this study is to evaluate whether a new version of an amino acid based formula improves tolerance to milk in cow's milk allergic infants/young children.
- Trial name
- NCT01109966
- Testing
- Special Medical Food
- Where
- 7 sites in France, Germany and 1 more
- Volunteers
- 34 people
- Sponsor
- Nutricia Research
Urea Cycle Disorders
Clinical Food Study to Evaluate the Effect of KB195 on Gut Nitrogen Metabolism in Patients With Urea Cycle Disorders
This clinical food study aims to explore the effect of KB195, a novel mixture of oligosaccharides, on the metabolism of nitrogen by the microbiome in patients with urea cycle disorders (UCDs).
- Trial name
- NCT03797131
- Testing
- KB195 (a novel mixture of oligosaccharides)
- Where
- Switzerland
- Volunteers
- 4 people
- Sponsor
- Kaleido Biosciences
To Assess the Safety and Tolerabiltiy of an Amino Acid Composition in Subjects With Sickle Cell Disease, Anemia, Sickle Cell
To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease
This is an open-label study to understand the safety and tolerability of AXA4010, a novel composition of amino acids in adult and adolescent subjects with sickle cell disease over 12 weeks.
- Conditions
- To Assess the Safety and Tolerabiltiy of an Amino Acid Composition in Subjects With Sickle Cell Disease, Anemia, Sickle Cell, Sickle Cell Anemia, Sickle Cell Disorders
- Trial name
- NCT04134299
- Testing
- AXA4010
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Axcella Health, Inc
Cow's Milk Allergy
Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula in Infants With Cow's Milk Protein Allergy
This is a multicenter, controlled, randomized, prospective, non-inferiority, double blind intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice hydrolysed protein formula compared to an…
- Trial name
- GRITO-14 (NCT02405923)
- Testing
- HRF, eHF
- Where
- 5 sites in France, Spain
- Volunteers
- 117 people
- Sponsor
- Laboratorios Ordesa
Chronic Hepatitis B
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Oral HRS5091 in Healthy Subjects and Chronic Hepatitis B Patients
The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and food effect of HRS5091.
- Trial name
- NCT04480294
- Testing
- HRS5091
- Where
- China
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Generally Healthy Kids Consumption Soy Protein Foods as Part of Daily Diet
Effects of Soy Protein on Body Composition and General Health in Healthy Children
The aim of this clinical trial is to assess the effects of daily consumption of soy protein foods on body composition, general health status and dietary intake outcomes in generally healthy children.
- Trial name
- NCT02413710
- Testing
- Soy protein containing foods, Dietary Guidance
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- DuPont Nutrition and Health
Prader-Willi Syndrome, Hyperphagia
Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome
This Phase 2b/3 double-blind, placebo-controlled study will evaluate the safety, tolerability, and effects of livoletide on food-related behaviors in patients with Prader-Willi Syndrome (PWS).
- Trial name
- ZEPHYR (NCT03790865)
- Testing
- Livoletide
- Where
- 37 sites in United States, Australia and 6 more
- Volunteers
- 158 people
- Sponsor
- Millendo Therapeutics SAS
Infant Development
Effect of a New Infant Cereal on Weight Gain
The purpose of this study is to determine whether a new infant cereal has an effect on weight gain and intestinal microbiota compared to a standard cereal in healthy infants .
- Trial name
- CEOBE (NCT02165956)
- Testing
- New Infant Cereal, Standard Infant Cereal
- Where
- 5 sites in Spain
- Volunteers
- 195 people, healthy volunteers welcome
- Sponsor
- Laboratorios Ordesa
Healthy
Chewing Capability Study for Infants and Toddlers
The main objective of the study is to conduct a pilot study on the characterization of the mastication abilities of infants and toddlers using different commercial cereal based products in order to gain knowledge and be able to…
- Trial name
- NCT02156986
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Prader-Willi Syndrome
Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome
The purpose of this study was to evaluate the effects of a once daily subcutaneous injectable formulation of setmelanotide in obese participants with Prader-Willi syndrome on tolerability, weight loss, and hyperphagia-related…
- Trial name
- NCT02311673
- Testing
- Setmelanotide
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Moderate Acute Malnutrition
Supplementary Food for Moderate Acute Malnutrition in Children
Children with moderate acute malnutrition will be recruited in order to receive an intervention which consists in the consumption of a single serving of SF-cookies daily, 7-days a week for 12 months and 12 educational sessions on…
- Trial name
- NCT02571764
- Testing
- Nutritional Oats Cookie
- Where
- Mexico
- Volunteers
- 248 people
- Sponsor
- PepsiCo Global R&D
Atopic Dermatitis
Effects of Lactobacillus Reuteri Plus Vitamin D3 in Children With Atopic Dermatitis
The purpose of this study is to evaluate in a randomized, double-blinded, controlled trial, whether a new food supplement containing Lactobacillus reuteri DSM 17938 and vitamin D3 (Reuterin® D3) may improve the SCORAD in…
- Trial name
- NCT02945683
- Testing
- Reuterin D3
- Where
- Italy
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Noos S.r.l.
Healthy
A Two Part Study to Assess Safety, PK, PD, and Food Effect of Oral HTL0016878
Phase 1, first in human, two-part, single centre, placebo-controlled, single and multiple ascending dose trial in healthy younger and elderly adult subjects, with an open-label, randomised, crossover arms to assess the effect of…
- Trial name
- NCT03244228
- Testing
- HTL0016878
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Nxera Pharma UK Limited
Functional Gastrointestinal Disorders, Functional Abdominal Pain
Effect of 35624® Alflorex® in Functional Gastrointestinal Disorders (FGIDs) in Children.
The aim of this study is to evaluate the effect of supplementation with Bifidobacterium longum 35624® Alflorex® on frequency and severity of symptoms of abdominal pain using an adapted Irritable Bowel Symptom Severity Scoring…
- Trial name
- NCT04922476
- Testing
- Alflorex®
- Where
- Chile
- Volunteers
- 65 people
- Sponsor
- PrecisionBiotics Group Ltd.
Asthma
Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children
To determine the effect of medical food on reducing asthma symptoms in asthmatic children.
- Trial name
- NCT01087710
- Testing
- medical food with EPA and GLA, vitamins and minerals, medical food minus EPA and GLA, antioxidant vitamins/minerals
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Abbott Nutrition
Peanut Allergies
Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy
The goal of this clinical trial is to evaluate the safety, pharmacokinetics, and effectiveness of MY006, a therapy designed to prevent severe or potentially life-threatening allergic reactions caused by accidental peanut intake.
- Trial name
- NCT07287033
- Testing
- MY006 Low Dose, MY006 Mid Dose, MY006 High Dose
- Where
- 9 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Mabylon AG