View clinical trials related to Body Weight.
Filter by:This observational placebo-controlled pilot study is intended to document whether or not Lyzme5, an over-the-counter (OTC) proprietary nutritional supplement product can positively impact, (a) weight and, (b) cholesterol levels in man.
Clinical management of very low birth weight newborns (VLBW <1250g) consists in several challenges to adapt immature physiological systems to extrauterine life. Advances in neonatal medicine for pulmonary and/or neurological and/or cardiovascular diseases have significantly improved outcomes of these children. However, the gastro-intestinal (GI) tract remains a major cause of morbidity due to 1. the immaturity of GI functions (prolonged ileus, bacterial overgrowth and translocation), 2. the complication of GI tract immaturity: intestinal perforation and enterocolitis necrotizing) 3. the need of a prolonged parenteral nutrition and its complications (central venous catheter infections, sepsis, electrolyte disturbances) but without generate a high proof level on this targeted population (<1250g). The GI functions are progressively acquired during development and are largely sensitive to the environment, especially the intestinal luminal content. Indeed, probiotics and prebiotics have shown beneficial effects upon GI functions of newborns. One of the metabolite of the gut flora potentially involved is the butyrate. Butyrate is a short chain fatty acid produced in the colon by the microbiota (carbo-hydrates degradation). The colonic amount of butyrate increases gradually after birth. The beneficial effects of butyrate are related to its properties upon the epithelial barrier (anti-inflammatory, antioxidant, barrier repair) and upon the enteric nervous system (network of neurons and glial cells) that regulate GI functions and in particular colonic motility. To date, there is no clinical consensus to manage digestive disorders of VLBW. Several clinical studies have assessed the effects of prokinetic drugs, dietary supplements (probiotics, prebiotics) but without generate a high proof level on this targeted population. In this context, a recent study of our Research Unit (INSERM-CIC Mère-Enfant 004) has shown benefit effects of oral probiotics supplementation in children with birth weight greater than 1000g but not in extreme preterms with birth weight less than 1000g. The main hypothesis to explain theses results lies in the intensive use of antibiotic and feeding interruption frequency in this targeted population which induce disturbances in the composition of the gut lumen (in particular the flora). Colonic enemas assessed in various observational studies concerning VLBW seem to demonstrate a clinical efficiency upon the colonic transit, underlying by mechanical and osmotic mechanisms. Here, the investigators propose to evaluate the clinical efficiency of butyrate enemas by a prospective randomized clinical trial blinded design. The purpose of NEOTRANS study is to demonstrate that butyrate enemas may improve the nutritional management of extreme preterm less than 1250 grams, by facilitating the development of colic motility and clinical nutrition tolerance.
Background: - Overweight and obese children and adults often have lower levels of growth hormone in the blood. Regulation of growth hormone may be tied to weight and free fatty acids in the blood. Current tests of growth hormone (such as those used when evaluating the heights of children who are markedly shorter than other children of comparable age) may be affected by other factors, including obesity. Researchers are interested in evaluating the levels of growth hormone and free fatty acids in the blood of children between 7 and 14 years of age who weigh more than children of a comparable age, or who are shorter than other children of a comparable age and have been recommended for growth hormone testing as part of an evaluation for their height. Objectives: - To determine the effect of changes in free fatty acids in the blood on changes in growth hormone secretion in overweight or shorter children and young adolescents. Eligibility: - Children and adolescents between 7 and 14 years of age who weigh more than or are shorter than other children of a comparable age and do not have any medical illnesses. Design: - Participants will have two study visits, one of which will be a half day screening visit in the outpatient clinic and one of which will require 2 nights as an inpatient at the National Institutes of Health Clinical Center. - Participants should not eat or drink anything except water after 10 PM the night before or on the morning of the screening visit. - At the screening visit, participants will have a physical examination and medical history, provide blood and urine samples, have an oral glucose tolerance test (to check blood sugar levels), and have an x-ray of the left hand to check bone age. - The inpatient study visit will involve a physical examination and medical history, a full x-ray scan to study body fat and muscle, frequent blood tests throughout the visit, and various medications to stimulate growth hormone production and lower levels of free fatty acids in the blood.
RATIONALE: Cyproheptadine hydrochloride may help improve appetite and lessen weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine hydrochloride is more effective with or without nutritional supplementation in improving weight and quality of life of young patients with weight loss caused by cancer or cancer treatment. PURPOSE: This randomized phase II trial is studying cyproheptadine hydrochloride to see how well it works when given together with or without nutritional supplementation in treating young patients with weight loss caused by cancer or cancer treatment.
The purpose of this study is to find out if remeron, also called mirtazapine, can help you prevent weight loss while on treatment for your cancer. Remeron is currently used to treat depression and has not been approved by the Food and Drug Administration for use to treat weight loss.
A majority of patients who suffer from mental illness are treated with serotonin regulating FDA approved medications. Some of these medications also block histamine transmission, increase blood prolactin levels, induce insulin resistance, hyperlipidemia, and promote sedation. All of which lead to weight gain and obesity. Many of these drugs are generally safe and effective but do carry the risk of a long term side effect in that acute and gradual weight gain of 10-30 pounds over a few months to a year of treatment. The detrimental gain of 7% of pre-drug weight is reported with many antipsychotics, mood stabilizers and some antidepressants. This weight gain may subsequently add to medical co-morbidity ( ie diabetes, hypertension, osteoarthritis, coronary artery diseasem, hyperlipidemia… ) This therapeutic manipulation of brain serotonin functioning may be associated with abnormal increases in carbohydrate cravings, consumption and weight gain. It is possible that insulin resistance occurs as a direct effect or as an indirect effect of weight gain, particularly in patients prone to weight gain or diabetes due to genetic loading. Leptin, a chemical associated with feedback signaling that reduces appetite and adipose tissue growth may also become insensitive. These multiple insults may lead to the worst weight gain in patients taking clozapine, olanzapine, and mirtazapine. Diet and exercise and lifestyle modification are the usual initial interventions, though being depressed, anxious, bipolar, or schizophrenic often interferes with the ability to make these changes. In fact most of the studies which look at these weight loss interventions occur in patients who are institutionalized, on restricted diets and may respond to token economy systems while on longer term inpatient unit stays. This token economy approach is not easily translated to usual outpatient or short term inpatient practice settings. In these settings, if lifestyle modification approaches fail, patients may be placed on FDA approved diet medications (sibutramine, orlistat, ionamin…) which carry significant side effect risks. Some patients are even placed on the epilepsy medications such as zonisamide or topiramate at an even greater side effect risk. In a similar weight gain prone group, there is growing literature in the diabetes population that the use of high dose chromium improves (lowers) insulin resistance by way of increasing insulin binding to cells, receptor numbers, and insulin receptor kinase activity. Lower fasting blood glucose levels in the blood generally occurs. Some reports show a reduction in blood lipid/cholesterol levels at higher chromium dosing as well. Recently, chromium piccolinate was studied in depressed patients, especially those with atypical features (usually fatigue, weight gain, carbohydrate cravings). Although there was no change in depression symptoms overall, carbohydrate cravings improved. This paper was presented at the 2005 American Psychiatric Association Annual Meeting in Atlanta. As a foil, a few papers in non-diabetics,non-depressed healthy volunteers showed little to no effectiveness in lowering blood sugar levels. Furthermore, one investigator (JLM) has published data showing acute , clinically significant weightgain in serotonergically treated psychiatric inpatients. The authors theorize that the use of chromium may reduce carbohydrate craving, appetite and thus protect against weight gain side effects. Given this pivotal paper in the depressed population, effectiveness data in the diabetes population and some possible metabolic ties between these two populations, the author wishes to study the effect of chromium piccolinate in mentally ill subjects who are being started on serotonergic manipulating medications while in an inpatient treatment setting. These patients will be followed during their inpatient stay and then be followed after discharge for a single visit to determine acute interventional effects of chromium piccolinate. We feel chromium piccolinate is less toxic/hazardous than many of the weght loss medications that we currently use and therefore suggest a long term randomized, controlled study where subjects will receive active drug (chromium piccolinate) or placebo at the start of any serotonergic treatment while inpatient. The chromium piccolinate and the placbo will be obtained from the Nutrition 21 company, which has been approved by the FDA as a source of this product.
The aim of the study is to determine mechanisms leading to glutathione deficiency in low birth weight newborn babies. Compared to full term neonates, depletion in this population may be due to a decreased synthesis rate or to an enhanced utilization or a combination of both mechanisms.The protocol is constituted of two steps. The objective of the first step is to quantify the blood concentration of glutathione in the artery and the vein of umbilical cord in full term newborn babies. Objectives of the second step are to determine if the glutathione synthesis rate, measured in vitro, is lower in erythrocytes collected from umbilical cord blood of low weight newborn babies compared to full term newborn babies. In this case, the next objective will be to determine if the adjunction of an excess of cysteine in vitro can restore the glutathione synthesis rate in these cells.
This is a randomized, double-blind, placebo-controlled, multicenter, multinational study. Approximately 78 subjects (39 per treatment group) will be randomized into this 16 week study. A screening visit will be used to determine subject suitability for inclusion in the trial. Within 7 days of the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned to 1 of the following 2 treatment groups: - Olanzapine OD plus betahistine 24 mg BID (48 mg/day total), - Olanzapine OD plus matching placebo BID. Double-blind treatment will continue for 16 weeks. During this period, olanzapine dosage will be determined according to the discretion of the treating physician. In addition, 5 study visits (at 2, 4, 8, 12, and 16 weeks) will take place. Study medication (betahistine or matching placebo) will be administered BID (in the morning and together with olanzapine in the evening). The primary statistical hypothesis to be tested is that the mean change from Baseline to Week 16 will be different between the treatment and placebo groups
Weight loss achieved by dieting induces multiple changes. These changes include a decrease in metabolic rate (the rate in which the body burns its calories), an increase in appetite and other physiological and hormonal changes that may be the cause of failure in dieting. Many of these parameters that have never been evaluated when weight is lost after gastric bypass surgery will be tested in this study.