Clinical trials: Dietary Protein
- Condition Dietary Protein
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Allergy
Acceptability and Palatability Study of Paediatric Amino Acid Feed
Product acceptability and palatability data from a minimum of 15 participants are required to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service Executive (HSE) for Ireland for…
- Trial name
- NCT06547346
- Testing
- Alfamino Junior
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Société des Produits Nestlé (SPN)
Phenylketonuria
GMP Drink for PKU Study
This study will evaluate the safety, gastrointestinal (GI) tolerance, acceptability and compliance of a Glycomacropeptide-based protein substitute for patients with Phenylketonuria (PKU).
- Trial name
- NCT02915510
- Testing
- Glycomacropeptide-based protein substitute
- Where
- 5 sites in United Kingdom
- Volunteers
- 40 people
- Sponsor
- Nutricia UK Ltd
Growth Acceleration
Effect of the Level of Dietary Protein on Body Composition
The purpose of this study is to determine if toddlers and children who were fed breast milk or infant formulas at different levels of protein between 3 and 12 months of age have differences in growth and body composition at 3 and…
- Trial name
- NCT01489098
- Where
- 2 sites in United States
- Volunteers
- 178 people
- Sponsor
- Société des Produits Nestlé (SPN)
Prematurity
Dietary Protein in the Very-low-birth-weight Infant
In this randomized study The investigators aim to compare the growth of very-low-birth-weight (VLBW) infants fed either a high protein or a standard protein preterm infant formula.
- Trial name
- NCT01208493
- Testing
- preterm infant formula with high protein levels, preterm standard infant formula
- Where
- 4 sites in United States, Belgium and 2 more
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy
Effect of the Level of Dietary Protein on the Infant Hormonal Profile and Body Composition
A double blind, controlled, randomized, single site clinical trial of 2 parallel groups (Low protein formula =LoF and High protein formula =HiF) with a breastfeeding group (BF) as reference from birth to 1 year of age and a…
- Trial name
- NCT02282488
- Testing
- Low protein formula, High protein formula
- Where
- France
- Volunteers
- 238 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Infant Nutrition
Effect of the Level of Dietary Protein on Infant Growth
The purpose of this study is to determine whether infants fed a formula with protein levels different than a standard infant formula have similar growth and development.
- Trial name
- NCT00716105
- Testing
- Standard infant formula, Infant formula with different level of proteins
- Where
- 2 sites in United States
- Volunteers
- 405 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis
- Trial name
- NCT02137382
- Testing
- Creon®, Creon N
- Where
- 7 sites in Hungary, Spain
- Volunteers
- 41 people
- Sponsor
- Abbott
Phenylketonurias
Compliance, Tolerance and Acceptability of a Tablet Protein Substitute for the Dietary Management of Phenylketonuria
Thirty eligible PKU patients (≥ 8 years), identified as tablet protein substitute users, will be recruited. Patients will firstly observe a 7-day baseline period, in which participants will continue with their existing diet…
- Trial name
- NCT03333720
- Testing
- Phenylalanine-free protein substitute tablets
- Sponsor
- Nutricia UK Ltd
Tyrosinemia, Type I, Tyrosinemia, Type II
Acceptability/Tolerance of Protein Substitutes in Tablet Form for the Dietary Management of Rare Aminoacidopathies
The purpose of this prospective, observational study is to evaluate the tolerability and acceptability of Zero minis, a range of protein substitute tablets for use in the dietary management of children with either TYROSINAEMIA…
- Conditions
- Tyrosinemia, Type I, Tyrosinemia, Type II, Tyrosinemia, Type III, Alkaptonuria
- Trial name
- ZeroMinisMR (NCT06298292)
- Testing
- Zero minis (range of protein substitutes in tablet form)
- Volunteers
- 15 people
- Sponsor
- metaX Institut fuer Diatetik GmbH
PKU
Evaluation of PKU UP
PKU UP is a prospective, single-arm, open-label, 26-week acceptability study to evaluate PKU UP for the dietary management of participants with phenylketonuria (PKU).
- Trial name
- PKU UP (NCT05995717)
- Testing
- PKU UP
- Where
- 7 sites in United Kingdom
- Volunteers
- 16 people
- Sponsor
- Vitaflo International, Ltd
Growth Disorders, Dietary Exposure
Evaluating the Effects of an Oral Protein Supplement on Children's Growth Patterns
This single-center, randomized controlled pilot study aims to evaluate the efficacy of TruHeight Growth Protein Shake on improving growth patterns in children aged 4-17 years.
- Conditions
- Growth Disorders, Dietary Exposure, Child Development, Bone Development Abnormal
- Trial name
- NCT06329388
- Testing
- TruHeight Growth Protein Shake
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- TruHeight Vitamins
Phenylketonurias, Hyperphenylalaninaemia
PKU Low Calorie Drink Study
This study will evaluate the compliance, acceptability, gastrointestinal (GI) tolerance and safety of a lower calorie amino acid based liquid protein substitute for patients with Phenylketonuria (PKU) or hyperphenylalaninemia…
- Trial name
- NCT04272736
- Testing
- Low calorie protein substitute
- Sponsor
- Nutricia UK Ltd
Diet Habit
Dietary Protein Preferences of Adolescent Athletes
This is a survey study to gauge the interest of young athletes ages 12-19 in plant-based protein products. The teen competitive athlete is a core target for the Gatorade brand and, as such, understanding their preferences and…
- Trial name
- NCT06704477
- Testing
- Survey
- Where
- United States
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- PepsiCo Global R&D
Dietary Intervention
Growth of Infants Fed New Starter Formula
The purpose of this study is to assess the growth of infants fed a novel starter formula containing synbiotics and different protein levels, compared to a standard starter infant formula, during the first four months of life.
- Trial name
- NCT01079208
- Testing
- test starter infant formula, test starter infant formula with synbiotics, control standard formula
- Where
- 3 sites in United States
- Volunteers
- 297 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
PKU, Tyrosinemias
GMP Case Studies of Tolerance, Safety and Acceptability in PKU and TYR
Three new protein substitutes have been developed to help with compliance in PKU and TYR patients, which are powdered protein substitutes, low in Phe and, low in Phe and Tyr respectively, with a mixed balance of glycomacropeptide…
- Trial name
- NCT05062226
- Testing
- PKU/TYR GMP Protein Substitute
- Where
- United Kingdom
- Volunteers
- 45 people
- Sponsor
- Nutricia UK 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
Phenylketonuria (PKU) and Hyperphenylalaninemia, Brain Diseases, Metabolic, Inborn
Market Research of a Slow Release Protein Substitute for the Dietary Management of PKU
XPhePiccosMR is a prospective, single-arm, open label, observational study that aims to evaluate the acceptability and tolerability of XPhe Piccos, a slow-release, phenylalanine-free protein substitute in the form of tiny…
- Conditions
- Phenylketonuria (PKU) and Hyperphenylalaninemia, Brain Diseases, Metabolic, Inborn, Brain Disorder, Metabolic, Brain Diseases
- Trial name
- XPhePiccosMR (NCT07802366)
- Testing
- Slow release, phenylalanine-free protein substitute tablets
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- metaX Institut fuer Diatetik GmbH
Phenylketonurias, Hyperphenylalaninaemia
Acceptability and Tolerance of a Ready-to-use Protein Substitute in Tablet Form for the Dietary Management of Phenylketonuria
The purpose of this prospective, observational study is to evaluate the tolerability and acceptability of phenylalanine-free protein substitute tablets for young children with PKU aged of 7 years or older.
- Conditions
- Phenylketonurias, Hyperphenylalaninaemia, Tetrahydrobiopterin Deficiency
- Trial name
- NCT04375592
- Testing
- Phenylalanine-free protein substitute in tablet form (XPhe minis)
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- metaX Institut fuer Diatetik GmbH
Phenylketonuria, Inborn Errors of Metabolism
Evaluation of PKU Explore
To evaluate the acceptability, tolerance and effect on metabolic control of PKU Explore, a renovated Phe free protein substitute for the dietary management of PKU in children from 6 months to 5 years.
- Trial name
- PKU Explore (NCT03168399)
- Testing
- PKU Explore
- Where
- 3 sites in United Kingdom
- Volunteers
- 22 people
- Sponsor
- Vitaflo International, Ltd