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NCT ID: NCT02827760 Completed - Gut Microbiota Clinical Trials

The Effect of Prebiotic Synergy1 Supplementation on Microbiota, Protein Metabolism and Gastrointestinal (GI) Symptoms in People Consuming High Protein Diet

ITF
Start date: July 2016
Phase: N/A
Study type: Interventional

The composition and metabolism of human gut microbiota play crucial roles in health. Microbial colonisation of the gastrointestinal tract varies widely, with the large intestine having not only the highest density of microbes in terms of bacterial cells per gram but also the most metabolically active microbial community. Genetics, mode of birth, infant feeding patterns, antibiotic usage, sanitary living conditions and long term dietary habits contribute towards shaping the composition of the gut microbiome. Diet clearly has a major impact on variation in the gut microbiota composition, and this can be detected in faecal samples after only a few days. The bacterial metabolism of dietary components produces much chemical diversity in the large intestine with protective or detrimental effects on disease development. Dietary protein levels are relatively high in western European populations, up to 103g/d, as reported by Food and Agriculture Organization. This may result in high levels, entering the large gut where it can become a substrate for proteolytic bacteria. Protein specifically can provide nutrition for microorganisms but metabolites from bacterial protein breakdown can be detrimental. Protein intake from the diet might not be the only source of microbial proteolysis; the human body also secretes considerable amounts of protein into the digestive lumen which can potentially be used by the microflora. On the contrary, end products of carbohydrate metabolism can be positive for health. In this context, prebiotics are carbohydrates that are resistant to digestion and can become available for bacteria in the colon to produce short chain fatty acids and inhibit the production of harmful metabolites. A switch towards more carbohydrate metabolism in the colon, at the expense of proteolysis therefore has positive capacity through the production of more benign metabolites. Rationale for design Prebiotics are dietary ingredients that target carbohydrate digesting bacteria only. Given the high intake levels of protein in Western populations, they may be useful to modulate the composition/activity of the microbial gut ecology for improved health. Among prebiotic nutrients, inulin-type fructans (ITF) are well characterized and their administration promotes growth of beneficial microorganisms like Bifidobacterium spp. .These microorganisms are involved in the reduction of intestinal endotoxin concentration, improve glucose tolerance, exert benefits upon immune function and inhibit pathogens. In healthy individuals, ITF intake promotes satiety and modulates gut peptides regulating food intake. The aim of the present study is to investigate the effect of inulin-type fructans (ITF) on the negative consequences of colonic fermentation in individuals consuming high protein diets. The hypothesis to be tested is that their action promotes carbohydrate degrading bacteria at the expense of protein utilisers.

NCT ID: NCT02827708 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment

PIONEER 5
Start date: September 20, 2016
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes and moderate renal impairment.

NCT ID: NCT02827318 Completed - Hunger Clinical Trials

Eating Disinhibition and Vagal Tone and the Postprandial Response to Glycaemic Load

Start date: September 2015
Phase: N/A
Study type: Interventional

Reducing the glycaemic load (GL) of the diet may benefit appetite control but its utility is complicated by psychological influences on eating. Disinhibited behaviour, a risk factor for overconsumption, is characterized by reduced prefrontal cortex activity, which in turn directly modulates vagal tone; a phenomenon inversely associated with blood glucose (BG) and insulin levels. This double blind randomised controlled trial explores the influence of disinhibited eating and vagal tone (heart rate variability) on the postprandial response to GL and hunger.

NCT ID: NCT02825992 Completed - Clinical trials for Persistent Atrial Fibrillation

Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation

UNCOVER-AF
Start date: October 17, 2016
Phase: N/A
Study type: Interventional

A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-002 - EU) A prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian)

NCT ID: NCT02825862 Completed - Organ Donation Clinical Trials

Investigating Affective Attitude Question-behaviour Effects on Intention to Become an Organ Donor

Start date: February 2016
Phase: N/A
Study type: Interventional

The investigators aim to experimentally manipulate presence of questions on positive or negative affective attitudes to see if including these moderate as intention to become an organ donor. The methodology will be replicated across three international sites (RCSI Dublin, RCSI Bahrain, RCSI Perdana University).

NCT ID: NCT02825758 Completed - Clinical trials for Deficiency of Micronutrients

Evaluation of ZestiVits in Children and Adults on a Ketogenic or Restricted Therapeutic Diet

ZestiVits
Start date: February 17, 2017
Phase: N/A
Study type: Interventional

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 tolerance, palatability and compliance.

NCT ID: NCT02825745 Completed - Clinical trials for Nervous System Disorder

Use of Betashot in Children and Adults With Epilepsy

Start date: June 29, 2016
Phase: N/A
Study type: Interventional

In brief, this research is a prospective, feasibility study to evaluate the use of Betashot- a medium chain triglyceride- based (MCT) food for special medical purposes (FSMP) in children and adults diagnosed with epilepsy. MCT is a type of dietary fat used in the ketogenic diet.

NCT ID: NCT02825251 Completed - Diabetes Clinical Trials

Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes

Onset® 5
Start date: July 6, 2016
Phase: Phase 3
Study type: Interventional

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.

NCT ID: NCT02824315 Completed - Healthy Clinical Trials

Study to Investigate the Pharmacokinetic Interaction Between 2 Direct Acting Antiviral Agents Odalasvir and AL-335 and Between 3 Direct Acting Antiviral Agents Simeprevir, Odalasvir and AL-335 at Steady State in Healthy Japanese Participants

Start date: May 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the steady-state pharmacokinetics (PK) of simeprevir (SMV), odalasvir (ODV) and AL-335 (and its metabolites ALS-022399 and ALS 022227), when these drugs are co-administered in healthy Japanese participants.

NCT ID: NCT02823574 Completed - Clinical trials for Head and Neck Cancer

Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

CheckMate 714
Start date: November 8, 2016
Phase: Phase 2
Study type: Interventional

A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)