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Acute Nutritional Ketosis in VLCAD Deficiency: testing the metabolic basis for therapeutic use

To test if acute NK boosts muscle mitochondrial function in vivo in patients with VLCADD in order to establish a rational basis for therapeutic use in this disorder. A secondary objective is to gather data to test the working hypothesis that the…

Group rehabilitation for renal patients

The purpose of GRN-study is: 1. to determine the long-term effectiveness of a 12 weeks lasting physical exercise training program. 2. to determine the costeffectiveness of the 12 weeks lasting physical exercise training program. In aim of the GRN-…

A Study to Evaluate the Efficacy and Safety of GFT505 once daily on Steatohepatitis in Patients with Non-Alcoholic Steatohepatitis (NASH).
A Multicentre, Randomized, Double Blind, Placebo-Controlled study, with an adaptive design to allow for initial GFT505 80mg dosing versus placebo, followed by a second phase including GFT505 120mg dose, after review of 6-month safety analysis of the 80mg data on at least 50% of patients.

The primary objectives of this study are: - To evaluate the efficacy of GFT505 80mg and GFT505 120mg once daily (according to adaptive design, after 6-month interim safety analysis of the 80mg data on at least 50% of patients) for 52 weeks versus…

A Randomized, Controlled, Open-label, Multicenter, Phase IIb
Safety and Efficacy Study of HGT-1410 (Recombinant Human
Heparan N Sulfatase) Administration via an Intrathecal Drug
Delivery Device in Pediatric Patients with Early Stage
Mucopolysaccharidosis Type IIIA Disease

The primary objective of this study is to assess the potential clinical efficacy of HGT-1410administered via a surgically implanted IDDD in patients with MPS IIIA. Efficacy will bemeasured as a meaningful amelioration in the progression of cognitive…

Probiotic functionality of several probiotic supplements during gastro-intestinal transit in vivo in healthy human subjects

Primary objectiveTo measure the conversion rate of mono- and disaccharides into oligosaccharides and mannitol in the digestive tract by the action of food grade micro-organisms Secondary objectivesTo measure pH of gastric and duodenal fluids at…

Acute effects of capsaicin on energy expenditure, fat oxidation and satiety in negative energy balance

To investigate the acute effects of capsaicin on energy expenditure, substrate oxidation, appetite profile and ad libitum energy intake during negative energy balance.

Dietary protein requirements and caloric over-consumption on unbalanced diets

To determine ad libitum daily energy intake, energy balance and appetite profile in response to protein/carbohydrate and fat ratio over 12 consecutive days, and in relation to age, gender, BMI and FTO polymorphisms.

A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor (AMG 145 20110116)

Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every-2-weeks (Q2W) and every-4-weeks (Q4W), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C).Secondary objectives:…

Effects of beef protein consumption on energy intake - The protein leverage hypothesis

To determine ad libitum daily energy intake in response to protein/carbohydrate and fat ratio over 12 consecutive days, and in relation to age, gender, BMI and FTO gene alleles.

A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia (AMG 145 20110115)

Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every-2-weeks (Q2W) and every-4-weeks (Q4W), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C).Secondary objectives: Safety…

Energy expenditure and sleep in response to protein/carbohydrate and fat ratio

To determine energy expenditure and sleep in response to protein/carbohydrate and fat ratio of the diet over a short-term and long-term period of time.

Effects of a high-fat and a low-fat diet on early biomarkers of metabolic stress in blood and gene expression in the small intestine of healthy subjects

The objective of this study is to compare in healthy subjects the effects of a HF diet (40 En% fat) with those of a LF diet (20 En% fat) on early biomarkers and parameters of metabolic stress in blood and on expression of genes in the small…

A Randomized, Crossover, Pharmacokinetic and Pharmacodynamic Study to Determine the Safety and Efficacy of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cystagon® in Patients with Nephropathic Cystinosis

The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…

Impact of microbial communities on obesity

The aim of this study is to test the hypothesis that obesity and the microbial community in the human GI tract are linked

The effects of dietary fatty acids on postprandial markers for inflammation in healthy overweight men

The objective is to study whether saturated fatty acids induce a different postprandial change in inflammatory markers than cis-polyunsaturated fatty acids.

Effects of fenofibrate and fish oil on gene expression and metabolic changes in obese subjects

The objective of this study is to compare in obese subjects the effects of fenofibrate (200 mg/day) with those of fish oil (7.2 g/day) on expression of PPARα related genes and metabolic parameters.

Effect of prebiotic fibres on Intestinal Health and Functioning

To study effects of AXOS (1) on gut health including among other parameters intestinal transit time, fecal cytotoxicity, pH, inflammatory markers, short-chain fatty acids and microbiota composition), gut permeability and gut functioning (bloating,…

Effect of Fecal microbiotA Transplantation combined with MEditerranean Diet on insulin sensitivity in subjects with metabolic syndrome

To study the effect of a Mediterranean diet (MD) followed by lean donor fecal microbiota transplantation (FMT) versus the prescription of Mediterranean diet (MD) followed by autologous (own) FMT in male subjects with metabolic syndrome on peripheral…

A phase 1, randomized, double-blind, placebo-controlled, single-site study to assess the safety, tolerability, pharmacokinetics and food effect of MIN-102 following oral administration of single and multiple ascending doses in healthy male volunteers

The purpose of the study is to investigate to what extent MIN-102 is tolerated.It will also be investigated how quickly and to what extent MIN-102 is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, the effect of…

Non-invasive rapid assessment of non-alcoholic fatty liver
disease (NAFLD) using Magnetic Resonance Imaging with LiverMultiScan (RADIcAL)

Primary objective: To investigate whether the introduction of LiverMultiScan as a standardised diagnostic test for liver disease can prove a cost effective method in different EU territories.Secondary Objectives:- To investigate patient satisfaction…