Clinical Trials
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Nutrition and Dietetics
Short-term Investigation of Resveratrol on Fat Metabolism in Morbidly Obese Women Undergoing Gastric Bypass Surgery
Apr 2013The purpose of this study is to investigate potential metabolic effects of resveratrol in morbidly obese women undergoing gastric bypass surgery.
Gastric Electrical Stimulation (GES) for the Treatment of Obesity
Mar 2013The purpose of this feasibility study is to provide safety data on the implantable Exilis gastric electrical stimulation (GES) system, to individually adjust stimulation parameters to levels that are comfortable for implanted subjects during chronic daily treatment, and to collect data on acute gastrointestinal function and food intake responses to GES during in-clinic testing.
Cholesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant Patients (CHOLESS)
Mar 2013The primary objective of this study is to compare the efficacy and tolerability of ezetimibe vs. a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.
Essential Fatty Acids in Adult ADHD (OCEAN-GER)
Feb 2013The aim of this project is to investigate the effect of a dietary supplementation with essential fatty acids in adults on cognitive functions related to attention and impulse control in the general population and in individuals with a diagnosis of attention deficit hyperactivity disorder (ADHD).
Efficacy of Omega-3/Omega-6 Fatty Acids in Pre-school Children at Risk for ADHD
Feb 2013The efficacy of PUFAs (as nutritional supplement) in/for pre-school children with ADHS symptoms will be evaluated in a randomised controlled doubleblind trail with children aged 3-6 years.
Influence of Muscle Strength on the Energy Cost of Walking in Obese Subjects (OBELIX)
Feb 2013The purpose of this study is to evaluate the efficacy of 2 physical exercise training programs, with a supplementation in fruits and vegetables, on energy cost of walking. 60 subjects will be randomized into 2 groups. The first program will be consist of an interval strength training for 30 min on bicycle ergometer (which include strengthening exercises in an high intensity interval training). The second program will be conducted at a relatively low intensity of effort, corresponding to 50% of oxygen uptake (VO2) peak measured by indirect calorimetry. All subjects will receive a free supplement of 5 fruits and vegetables per day during all the intervention. The intervention will last 10 months in total : 5 month at the hospital fallow by 5 month at home.
The More & Less Study: A Trial Testing Different Treatment Approaches to Obesity in Preschoolers (M&L)
Feb 2013Obesity has been shown to be resistant to treatment in adults, adolescents, and in school age children, but not during early childhood. Yet knowledge on the effectiveness of early childhood treatment programs for obesity is still very limited, preventing the widespread implementation of such programs. The overarching purpose of this study is to evaluate the effectiveness of early treatment of childhood obesity. The investigators plan to perform a carefully-designed randomized controlled trial that will evaluate different treatment options offered to families with children with obesity, organized within the healthcare system and followed up for at least 1 year post-baseline. Participants will be children aged 4-6 years (N=180) with obesity and their parents. This study will facilitate a close examination of key treatment components and mechanisms of change. Results from this study will lead to better healthcare options for obesity treatment during childhood and ultimately to the prevention of obesity later in life from a public health perspective.
A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of Liraglutide in Obese Adolescent Subjects Aged 12 to 17 Years
Feb 2013This trial is conducted in Europe. The purpose of the trial is to assess safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of liraglutide in obese adolescent subjects aged 12 to 17 years.
Randomized Comparison of Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity
Jan 2013Bariatric surgery is the most effective treatment for morbid obesity. Roux-en-Y gastric bypass (RYGB) is a bariatric procedure with known safety and effectiveness. Laparoscopic sleeve gastrectomy (LSG) is a newer procedure gaining popularity. The aim of the study is to compare outcomes of these two surgical methods in terms of weight loss, improvement of common comorbidities of obesity and influence on metabolic and hormonal status.
Fructose and Fructans in IBS (FABS)
Jan 2013The purpose of the study is to investigate if patients with Irritable Bowel Syndrome (IBS) who also report bloating are more likely to report clinically important gastrointestinal symptoms after consuming fructose or fructans than after consuming glucose. We will also use MRI imaging to investigate the mechanisms by which those symptoms might be caused.
Kinematics of Obese Patients Perambulation (MARCHOBESE)
Jan 2013The aim of this study is to evaluate the consequences of sleeve gastrectomy on functional parameters of patients perambulation.
Environmental Chemicals and Their Role in Obesity (ENDORUP)
Jan 2013Hormonal disruption is the inappropriate alteration of the hormonal system by chemical substances that are present in our environment. Some chemical substances are capable of replicating, enhancing or reducing the production, release, transport or action of natural hormones. Therefore, they are called hormonal or endocrine disrupters. Some 'classic' endocrine disrupters such as pesticides and dioxins are considered responsible for infertility, cancer and thyroid problems. Recently, a number of additional chemical substances were stipulated to have endocrine disrupting capabilities. The industrial production of these substances in large quantities has led to an accumulation in our environment and thus possible negative consequences on human health. The aim of this study is to investigate the rol of these chemical substances in the occurence of overweight and obesity.
Omega-3 Fatty Acids Supplementation in ADHD
Jan 2013The overarching aim of the proposed study is to assess whether omega-3 fatty acids supplementation can augment the effects of methylphenidate in children with ADHD. The investigators hypothesized that omega-3 fatty acids supplementation will be associated with improved ADHD symptoms.
Resistance Exercise, Muscle Mass, Strength and Body Composition
Jan 2013A plethora of trials reported the positive effect of resistance exercise on functional and morphological parameters. Although a large amount of the studies used suboptimum devices and obsolete methods the results of these older studies were still considered as golden standard. The aim of the present study is thus to determine the proper effect of different resistance exercise protocols with and without adjuvant protein supplementation on functional and morphological muscle and body composition parameters in male untrained subjects 30-50 years old under special regard of modern medical imaging and segmentation technologies. Our general study hypothesis is that HIT-resistance exercise significantly impact relevant muscular parameters of the upper leg.
Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet (NEUROXAPOL)
Jan 2013Use lay language. Oxaliplatin is a reference anticancer drug in the treatment of colorectal cancer. However, its use is hampered by a specific neurotoxicity, which is characterized by acute thermal hypersensitivity, notably to cold temperatures, and by chronic neuropathy appearing with the repetition of chemotherapy cycles. To this date there is no effective therapy able to prevent and/or to treat these adverse drug reactions. So oncologists are sometimes strained to decrease anticancer doses or to stop chemotherapy; Previously, a polyamine deficient diet has been able to prevent acute oxaliplatin-induced hypersensitivity in animals. So we hypothesizes that a specific nutritional therapy, a polyamine deprived diet, may prevent acute oxaliplatin-induced hypersensitivity in patients.
Characterization of the Digestive Functions and the Enteric Nervous System in Obesity. Investigations of Relationships With Metabolism Disorders (EnteroNeurObesity)
Jan 201360 patients scheduled for bariatric surgery will be included into 3 categories (20 patients with non complicated obesity, 20 patients with metabolic syndrome and 20 patients with a type 2 diabetes or hypertension). 20 volunteers will be enrolled as normal referents. The patients and the volunteers will have a classical pre-operative check-up (fibroscopy, oesophageal pHmetry and manometry) and extra investigations as isotopic gastric empty exam, lactulose oro-caecal transit exam, intestinal permeability test calculated by lactulose-manitol ratio urinary excretion. Intestinal and colonic biopsies will be also provided for studying permeability. For only patients, samples from the gastric resection will be provided for analysing the enteric nervous system and motricity.
Treatment of antipsychotic associated obesity with a GLP-1 Analogue: the TAO study
Jan 2013To investigate if 3 months treatment with a GLP-1-analogue can reduce antipsychotic associated obesity in non-diabetic patients with a diagnosis within the schizophrenic spectrum
The Relationship of Essential Fatty Acids to Adult ADHD: The OCEAN Study (Oils and Cognitive Effects in Adult ADHD Neurodevelopment)
Dec 2012The aim of the study is to provide preliminary data on the relationship of Essential Fatty Acids (EFAs) to cognitive and electrophysiological measures of brain and behavioural functions in adults with attention deficit hyperactivity disorder (ADHD) and controls. This main aim will be achieved in two ways. First the investigators will measure the relationship of the various measures to blood levels of EFAs in ADHD cases and controls. Secondly, the potential effects of dietary supplementation with EFAs on cognitive-electrophysiological and behavioural measures in ADHD cases will be investigated. We will evaluate the extent to which changes in neuronal activity and cognitive performance are related to behavioural and functional measures over time. This is to be carried out by conducting a randomised controlled trial of fish oil supplementation in adults with ADHD (The OCEAN study: Oils and Cognitive Effects in Adult Neurodevelopment).
The effect of vitamin D supplementation on immune response following hepatitis B vaccine in incident and prevalent hemodialysis patients with vitamin D deficiency
May 2012The main objective of this trial is to evaluate whether vitamin D supplementation is able to ameliorate the response of vitamin D-deficient hemodialysis patients receiving hepatitis B immunization
Influence of obesity and gastric bypass on medication absorption: pharmacokinetic study
May 2012To evaluate the influence of obesity and a gastric bypass on the absorption of drugs
MelaViD: A Trial on Vitamin D Supplementation for Resected Stage II Melanoma Patients
Apr 2012The purpose of this trial is to assess the effect of vitamin D supplementation on recurrence in resected stage II melanoma patients.
Study to evaluate the pharmacokinetic of vitamin D (cholecalciferol) in patients with obesity after bariatric surgery in vitamin D deficiency and after normalization
Mar 2012Establish vitamin D supplementation in obese patients after bariatric surgery.
A randomized double blind placebo controlled study on the effects of fenretinide Lym-X-Sorb on insulin sensitivity in obese insulin resistant subjects
Feb 2012To assess the effects of fenretinide on hepatic and peripheral insulin sensitivity in obese, insulin resistant subjects
Cyp3A4 metabolism before and after surgery induced weight loss in morbidly obese patients, using midazolam as a model drug
Sep 2011To compare midazolam pharmacokinetics in morbidly obese patients before/during a gastric bypass and 0.5-2 year after surgery.
An efficacy, safety and pharmacokinetic study on the short-term and long-term use of METFORMIN in obese children and adolescents
Jul 2011The primary objective of the METFORMIN study is to determine the efficacy of metformin in combination with lifestyle-intervention in obese children and adolescents with insulin resistance versus placebo with lifestyle-intervention.
Effects of Vitamin D supplementation on Vitamin D levels and immune activation in HIV infected individuals on antiretroviral therapy-A pilot study.
May 2011Investigate the role vitamin D supplementation on restoring vitamin D levels in HIV infected individuals on antiretroviral therapy.
Effects of Activia in IBS (MOSAIC)
Dec 2010The purpose of this study is to investigate the association between gut microbiota, immunology and typical pathophysiological factors in patients with IBS (all subtypes) AND to assess the effect of Activia consumption on GI symptoms provoked by a lactulose challenge test in IBS patients.
Randomised, multi-centre, double-blind, placebo-controlled trial of vitamin d supplementation in adult and adolescent patients with asthma
Oct 2010Does vitamin D supplementation influence time to first severe exacerbation and time to first upper respiratory tract infection in patients with asthma?
A Pan-European randomized, parallel group, two-arm placebo-controlled, double-blind multicenter study of Rimonabant 20mg once daily in the treatment of abdominally obese patients with impaired fasting blood glucose with or without other comorbidities
Oct 2010To determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting Plasma Glucose (FPG), HDL-Cholesterol (HDL-C) and triglyceride (TG) levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with impaired fasting blood glucose and with or without associated comorbidities.
The Effects of Normalising Sex Hormone Levels in Obese Hypogonadal Men: A Prospective Randomized Comparator Controlled Parallel Arm Clinical Trial
Oct 2010The primary objective of the research project is to determine the effect of twelve weeks’ treatment with an aromatase inhibitor (Femara®, 2.5mg weekly) on the change in the serum concentration of the pro-inflammatory cytokine, C Reactive Protein, as measured by the Roche® Cobas immuno-turbidimetric test and compare it to that of twelve weeks’ treatment with a depot intramuscular formulation of testosterone undecanoate (Nebido®, 1g every 6 weeks) and to that of six weeks of no treatment.
Parents as the Agent of Change for Childhood Obesity (PAAC)
Aug 2010The overall intent of this study is to explore a promising mode for delivering treatment for childhood obesity via parent education only, and to evaluate the cost effectiveness compared to the current gold standard treatment of parent-and-child dual education.
Targeting systemic inflammation to improve endothelial function in obesity
Jul 2010Does reducing inflammation in obese volunteers, using pentoxifylline, lead to an improvement in the health of blood vessels? We will measure the health of blood vessels by taking blood samples and carrying out an ultrasound scan of the blood vessel in the arm before and after treatment. This will address whether inflammation causes 'unhealthy' blood vessels in people with obesity.
Childhood Obesity Prevention Program for Hispanics
Jun 2010The purpose of this study is to evaluate the efficacy of a culturally-appropriate childhood obesity intervention with Hispanic families. The program aims at preventing childhood obesity by targeting parents to address nutrition, physical activity, and sedentary behaviors in their children.
A Single Centre, Open-Label, Randomised Multi-Dose Study to Assess Changes in the Brain Metabolism of Juvenile ADHD Patients After Thirteen Weeks of Daily Intake of 4 g Superba Krill Oil or 4 g omega-3 Enriched Fish Oil
May 2010To evaluate changes in the brain metabolism of juvenile ADHD patients after thirteen weeks of daily doses of 4 g Superba krill oil or 4 g omega-3 enriched fish oil
Efficacy of Metformin in Pregnant Obese Women, a Randomised Controlled Trial.
Mar 2010The aim of this study is to determine if metformin, administered to obese women during pregnancy, reduces the future life risk of obesity and metabolic syndrome in their babies.
A multicentre double blind placebo controlled clinical dose- finding study for three doses of Antiadipositum X 112 T® (Cathine-hydrochloride) vs. placebo in 240 patients with a body mass index (BMI) between 27 kg/m2 and 40 kg/m2
Feb 2010Primary criterion is weight reduction in kilogram in the treatment groups (group 1- 3) compared with the placebo group (group 0) after 12 weeks
Addressing Health Literacy and Numeracy to Prevent Childhood Obesity (GreenLight)
Dec 2009The aim of the study is to assess the efficacy of a low-literacy/numeracy-oriented intervention aimed at teaching pediatric resident physicians to promote healthy family lifestyles and prevent overweight among young children (age 0-2) and their families in under-resourced communities.
Fondaparinux population pharmacokinetic to morbid obese patients in post-operatory bariatric surgery
Nov 2009To evaluate pharmacodynamics parameters (absorption and elimination half life, clearance, distribution volume and their variability) of fondaparinux based on anti-Xa activity estimated by a non linear model at mixed effect of obese morbid patients (BMI >40kg/m2) with a daily subcutaneous injection of fondaparinux 2,5 mg during at least 5 days following a bariatric surgery
Does modulating the gut hormones, incretins, modify vascular function, thereby reducing the risk of vascular complications in insulin resistant individuals?
Nov 2009The overall aim of this research is determine whether increasing the levels of the gut hormones (incretins) by preventing their breakdown with the sugar lowering medication, Vildagliptin, improves 1) the function of both large and small blood vessels and 2) whether any observed improvements in blood vessel function translate to clinical benefits in the kidneys and the eyes in obese individuals.
Influence of a Dietary Supplement as Treatment of Migraine in Children and Adolescents
Nov 2009Migraine in children and adolescents can be associated with low serum levels of coenzyme q10, the key-enzyme of mitochondrial energy production.During migraine attacks inflammation is an important issue. Based on a double-blind placebo-controlled trial with coenzyme q10 in adults it is hypothesized that daily supplementation of coenzyme q10 as well as different antioxidative phytochemicals (from berries) and specific minerals and vitamins are able to reduce the "days with migraine" as primary parameter (open clinical trial).
Pilot Study Using a Dietary Intervention for Children With Irritable Bowel Syndrome
Oct 2009Malabsorption of certain foods (e.g. lactose) has been proposed as a cause of irritable bowel syndrome in adults and children. Recently, a diet that lowers intake of a combination of foods has been found to be effective in adults with IBS identified with fructose malabsorption. The purpose of this study is to determine whether a restricted fermentable substrate diet is effective in the treatment of irritable bowel syndrome in children.
Vitamin D in addition to RAAS blockade and dietary sodium for the Treatment of Urinary Excretion of albumin: the ViRTUE-study
Oct 2009Does paricalcitol have an additive antiproteinuric respons to RAAS blockade and low sodium diet?
Impact of an Integrated Obesity Management System on Patient's Care (ROGMF-2)
Oct 2009The investigators hypothesize that their program combining preceptorships with a virtual community will improve: (1) management and weight loss of obese/overweight subjects who are treated by PCPs for hypertension (HTN), type 2 diabetes (DM2) or impaired glucose tolerance (IGT); and (2) screening and initial management of obesity among unselected patients of PCPs who practice in FMGs.
A Double Blind, Randomised, placebo-contoled Trial to establish the safety and efficacy of a probiotic in subjects with Irritable Bowel Syndrome
Sep 2009The main efficacy variable will be; Responder Rates for adequate relief of abdominal pain/discomfortesponder and Rates for adequate relief of IBS symptoms
Community Based Obesity Prevention Among Black Women
Jul 2009This study will evaluate the efficacy of a behavioral intervention, designed to prevent weight gain among overweight and low obese (25-34.9 kg/m2) Black women (aged 25-44), compared to usual care.
Increasing Cure Rate of Hepatitis C Therapy in Obese Hepatitis C Patients
May 2009The purpose of this study is to determine whether obese people do not respond to hepatitis C treatment as well as lean people. This research studies whether obese people will show higher sustained virologic response rate if they lose weight by Orlistat use and dietary and lifestyle modification.
Increasing Cure Rate of Hepatitis C Therapy in Obese Hepatitis C Patients
Mar 2009The purpose of this study is to determine whether obese people do not respond to hepatitis C treatment as well as lean people. This research studies whether obese people will show higher sustained virologic response rate if they lose weight by Orlistat use and dietary and lifestyle modification.
Sleep and Obesity in Teenagers
Feb 2009This study aims to investigate 1.whether sleep extension results in improvements of endocrine and metabolic markers of obesity and diabetes in obese teenagers, 2.the relationship between habitual sleep quality and duration and markers of obesity and diabetes in lean and obese teenagers
Glutamine supplementation for cystic fibrosis: a parallel group randomized controlled trial
May 2008To assess the impact of glutamine supplementation on markers of infection and lung function in patients with cystic fibrosis and previous pseudomonas infection
Yunzhi as Dietary Supplement in Breast Cancer (YUNZHI-BC)
Apr 2008The purpose of this study is to assess the effects of a dietary supplement, the traditional Asian mushroom Yunzhi, as adjuvant in the treatment of patients with breast cancer.
Intensive Dietary Education to Lower Serum Phosphorus in Patients With Chronic Kidney Disease
Apr 2008The purpose of this study is to determine the effects of a more intensive, innovative dietary phosphorus educational intervention on reducing serum phosphorus levels, as well as improving dietary adherence, dietary satisfaction and phosphorus knowledge level in patients with chronic kidney disease.
Impact of n-3 Polyunsaturated Fatty Acids on Adipose Tissue Inflammation in Morbidly Obese Patients
Mar 2008Effect of n-3 polyunsaturated fatty acids (n-3 PUFA; Omacor®) on visceral adipose tissue inflammation
Mitochondrial Function in Pediatric Obesity
Dec 2007This study evaluates a novel, non invasive, safe method for predicting insulin resistance and diabetes in children using a magnetic resonance imaging (MRI) based technique to measure mitochondrial function. We propose to investigate mitochondrial function and glucose metabolism in obese and non-obese children in early, mid and late puberty.
A Pilot study to evaluate the Efficacy and Safety of GFT505 orally administered once daily (30 mg) for 28 days in atherogenic dyslipidaemic patients with abdominal obesity. A double blind, placebo-controlled and randomized study.
Aug 2007To evaluate the efficacy of GFT505 30 mg in reducing serum TG and increasing HDL-C levels compared with placebo in atherogenic dyslipidaemic patients with abdominal obesity. To assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 28 days.
Observational Study of Early Metabolic and Vascular Changes in Obesity (STYJOBS/EDECTA)
Jun 2007a prospective, observational study to improve the understanding of atherosclerosis, cardiovascular risk, low grade inflammation, and metabolic changes in obesity by investigation of the "non-biased" early phase
Fatty Liver in Chronic Hepatitis C (HCV): Is There a Difference in Oxidative Stress and Inflammation Compared to HCV Without Fatty Liver?
Apr 2007Aim of the study is to find out, whether patients with HCV and fatty liver have increased oxidative stress and inflammation than patients with HCV without fatty liver, and whether this is associated with a different nutritional status.
A 2-year, randomized, double-blind, placebo-controlled phase 3 study to evaluate the long-term efficacy and safety of CP-945,598 in the treatment of obese subjects
Jan 2007Determine the long term efficacy of CP 945,598 on body weight in obese subjects or overweight subjects with co morbid conditions after 1 and 2 years of dosing.
A randomized, double blind, two arm, parallel, placebo controlled study of rimonabant 20mg effect on high density lipoprotein kinetics in patients with abdominal obesity and additional cardiometabolic risk factors
Dec 2006The Primary End-point is the fractional catabolic rate of ApoA-I in HDL after 12 months of treatment.
A Phase IIb/III Randomized, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of MK-0364 in Obese Patients and in Overweight Patients with Obesity-related Co-morbidities.
Sep 2006In obese patients and in overweight patients with obesity-related co-morbidities, to assess the effects of MK-0364 after 1 year of treatment on: 1. body weight; 2. safety and tolerability during treatment.
To investigate the effect of vitamin K supplementation on markers of bone turnover and bone density in adolescents and adults with cystic fibrosis
Sep 2006To establish whether vitamin K supplementation in adolescent and adult patients with CF improves markers of bone formation.
Omega-3 Fatty Acids Supplementation for Adolescent Boys with Attention Deficit Hyperactivity Disorder : a double-blind, randomized controlled trial
Apr 2006ADHD symptoms are often carried through to the adolescent period and long-term intervention is often needed. Patients and their parents often choose alternative treatments for ADHD. Omega-3 fatty acids supplementation is one popular alternative treatment, and relatively safe, but the effectiveness has not been assessed enough . This study aims to evaluate whether EFA supplementation improves ADHD symptoms in ADHD male adolescents.
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