Clinical trials: Protein Metabolism Disorder
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
AL Amyloidosis
A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis (CARES)
AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down.
- Trial name
- NCT04512235
- Testing
- CAEL-101, cyclophosphamide, bortezomib, and dexamethasone (CyBorD) regimen
- Where
- 110 sites in United States, Australia and 17 more
- Volunteers
- 281 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Diabetes Mellitus
Effect of LY333531 on Vascular and Neural Functions
To determine if protein kinase C beta plays a significant role in vascular endothelial dysfunction, small fiber neural dysfunction, and oxidative stress associated with diabetes mellitus.
- Trial name
- NCT00482976
- Testing
- Ruboxistaurin
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Chromaderm, Inc.
Mevalonate Kinase Deficiency
Canakinumab in Patients With Active Hyper-IgD Syndrome
This pilot study is designed to evaluate the efficacy, the safety, and the pharmacokinetics (PK) / pharmacodynamics (PD) of canakinumab treatment in patients with HIDS.
- Trial name
- NCT01303380
- Testing
- Canakinumab
- Where
- 3 sites in Spain
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
Diabetes Mellitus, Dyslipidemia
Prevalence of Subclinical Atherosclerosis and Its Associated Factors in Hyperlipidemic Korean Adults With Diabetes
This study is to investigate correlation between Carotid Intima Media Thickness (cIMT) and several factors such as; hs C-reactive protein (CRP), HbA1c, lipid profile in Korean diabetic patients with atherosclerosis.
- Trial name
- ALTO (NCT01264263)
- Where
- 3 sites in South Korea
- Volunteers
- 181 people
- Sponsor
- AstraZeneca
Diabetes Mellitus, Type 2
C-Reactive Protein (CRP) in Obese Diabetic Women
The purpose of this study is to determine whether treatment with rosuvastatin for 6 months in obese type 2 diabetic women will improve their lipid profiles and thus prevent the progression to cardiovascular disease.
- Trial name
- NCT00262548
- Testing
- Rosuvastatin; improvement of lipid profile
- Where
- Mexico
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Malnutrition
Evaluation of a High Calorie, High Protein Tube Feeding Product in an Adult Population With or at Risk of Malnutrition
This prospective, observational study is designed to observe the use of a high calorie, high protein tube feed product in adults that are malnourished or at risk of malnutrition, as assessed by a clinician, and have been placed…
- Trial name
- NCT03459001
- Testing
- Tube Feeding Product
- Where
- 9 sites in Spain
- Volunteers
- 17 people
- Sponsor
- Abbott Nutrition
Malnutrition
Adding Appetite Stimulants to an ONS in Older Adults
Study to determine whether adding specific nutrients to a high-protein oral nutritional support (ONS), with and without fibre can reduce the feeling of satiety and may increase appetite in adults older than 65 years.
- Trial name
- APPOLO II (NCT06645184)
- Testing
- Oral nutritional supplement
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Overweight
Whey Protein Micelles and Thermogenesis in Overweight Subjects
The main objective of the trial is to measure the thermogenic effect of two different doses of whey protein microgels. It will be a randomized crossover double-blind design conducted in 20 subjects.
- Trial name
- Thermowhey (NCT02303080)
- Testing
- Control (WPM 0), WPM 30, WPM 50
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Malnutrition
TOLER-ENT Study: A Study to Investigate the Tolerance of the High Energy, High Protein Formula Sondalis® HP 2 kcal
A multicentre, prospective, open-label, single arm study for 2 months, involving adult patients under poorly tolerated Home Enteral Nutrition (HEN).
- Trial name
- SONDALIS (NCT05429853)
- Testing
- Sondalis® HP 2 kcal (with or without fibre)
- Where
- 2 sites in France
- Volunteers
- 17 people
- 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
Diabetes Mellitus
Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease
The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes with moderate proteinuria and…
- Trial name
- PLANET 1 (NCT00296374)
- Testing
- Rosuvastatin, Atorvastatin
- Where
- 116 sites in United States, Argentina and 9 more
- Volunteers
- 353 people
- Sponsor
- AstraZeneca
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
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
Lack of Satiety
Effects of Soy Protein/Soy Fiber on Measures of Satiety
The purpose of this study is to determine whether ingestion of a bar containing either added soy protein or soy fiber or both, increases subjective and objective measures of satiety compared to a control bar.
- Trial name
- NCT01358318
- Testing
- Satiety
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Solae, LLC
Cardiovascular Diseases, Dyslipidemia
Additional KIF6 Risk Offers Better Adherence to Statins
Many patients prescribed statins to lower their cholesterol stop taking their statin over time. The purpose of this study is to determine whether providing subjects their KIF6 carrier status (associated with increased…
- Trial name
- AKROBATS (NCT01068834)
- Testing
- KIF6 genetic test
- Where
- United States
- Volunteers
- 1,282 people
- Sponsor
- Medco Health Solutions, Inc.
Obesity
Safety Study of the Inhibition of Agouti-related Protein (AgRP) for the Management of Obesity and Weight Loss
Multiple pathways including peripheral and central hormones and neurotransmitters are involved in the regulation of food intake and body weight. One of the most studied pathways involves the melanocortin receptor.
- Trial name
- NCT00779519
- Testing
- TTP435
- Where
- 12 sites in United States, Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- vTv Therapeutics
PKU, Phenylketonurias
Market Research - Acceptability Trial for a New PKU Amino Acid Based Protein Substitute
The aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with PKU.
- Conditions
- PKU, Phenylketonurias, Inborn Errors of Metabolism, Metabolic Disease
- Trial name
- NCT04309331
- Testing
- Motion
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- Dr. Schär AG / SPA
Metabolic Syndrome
Protandim and the Metabolic Syndrome
Protandim will decrease markers of oxidative stress/inflammation in subjects with metabolic syndrome and proteomics will identify protein profiles that correlate with markers or/changes in oxidative stress.
- Trial name
- NCT01125501
- Testing
- Protandim
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- SomaLogic, Inc.
Cystinosis
Safety/Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Cysteamine Treatment Naive Patients With Cystinosis
This was a long-term, open-label study of the safety, tolerability and effectiveness of RP103 in cystinosis patients who were naïve to any form of cysteamine treatment.
- Trial name
- NCT01744782
- Testing
- RP103
- Where
- 2 sites in United States, Brazil
- Volunteers
- 17 people
- Sponsor
- Amgen