12 Clinical Trials for Various Conditions
The purpose of this study is to determine the ability of insect-derived protein supplements (IPC80 and Whole Buffalo Powder Ynsect®) to activate the mTORC1 pathway and protein synthesis in muscle cells. To achieve this aim, participants will consume a supplemental dose (0.25 g/kg body weight) of IPC80,Whole Buffalo Powder or whey protein. Blood samples will be drawn before and 15, 30, 60 and 90 minutes after the supplementation. Protein synthesis will be assessed using stably transfected C2C12 muscle cells with a plasmid (pcDNA3 luciferase) and to determine the ability of a protein source to activate mTORC1, stably transfected C2C12 muscle cells with a plasmid (pcDNA3-TOP luciferase) where the luciferase mRNA contains a 5'TOP. 5'TOP which is specifically regulated by mTORC1 activity will be used.
The purpose of this study is to determine the effects of repeated dosing vitamin C enriched hydrolyzed collagen (HC) over a 24hr period, compared to PrimaColl™ (PC), whey protein (WP) and placebo (PL), with prescribed exercise on collagen synthesis. To achieve this, participants will consume a supplemental dose of HC (20g with 50mg vitamin C), PC (20g with 50mg vitamin C), whey protein (20g whey isolate with 50mg vitamin C) or a placebo (20g maltodextrin with 50mg vitamin C) 1hr prior to an exercise bout (6 minutes of jump rope), this will be repeated three times over a 24h period. The amount of collagen protein synthesized will be indirectly measured by measuring pro-collagen type I N-terminal propeptide (PINP) in the serum before and 4hrs after the last exercise bout.
The purpose of this study is to determine the effects of food supplements and strength training on appetite, the amount of energy used, and body composition.
Our study aims to evaluate if the consumption of a Fruit and Vegetable Juice Concentrate (FVJC) vs. placebo can exert changes in the serum levels of Retinol Binding Protein 4 (RBP4), carotenoids, tocopherol, antioxidant capacity, pro-inflammatory markers, insulin sensitivity in conjunction with weight management in a cohort of lean as compared to overweight healthy six to ten year-old boys. The boys will undergo a detailed medical and family history and a complete physical examination during the screening visit. Careful anthropometric measures and body composition by DEXA will be performed. Nutritional and exercise counseling will be given at the start of the study. The outcome measures will include differences in serum RBP4, antioxidant levels, inflammatory markers and insulin sensitivity at baseline and six months after consumption of FVJC in a randomized double blind placebo control manner.
Type 2 diabetes is common in ethnic and, minority groups in developing and developed countries such as Africans, African Americans, Asians, Native Americans, Hispano-Latinos and Alaskan indians. A randomized controlled study to assess the efficacy of fermented papaya preparation and green tea infusates in latent diabetes (individuals newly diagnosed as diabetics) is proposed. Glycation products from excess glucose autooxidation can chemically modify DNA causing mutations and cause complex DNA rearrangements. Advanced glycation end-products which play a role as proinflammatory mediators in gestational diabetes can accelerate vascular occlusion by quenching the vasodilating agent nitric oxide. Interaction with high-affinity receptors located on monocytes and macrophages can enhance the production of free radicals and reactive oxygen/nitrogen species, the secretion of tumor necrosis factor-α, interleukin-1 and insulin-like growth factor I which can proliferate endothelial, mesangial and smooth muscle cells and hence contribute significantly to the pathogenesis of cardiovascular complications. The clinical markers include C-reactive proteins (inflammation indicators), protein C (markers of reno vascular injury), uric acid, natriuretic peptides, and the integrity of isolated adipocytes, glucose levels, lipid indices (triglycerides, total cholesterol, VLDL, HDL and LDL). Given that decreased functional activity of activated protein C affects the permeability of the glomerular capillary wall and enhances apoptosis of glomerular endothelial cells and adipodocytes, this has relevance to the pathophysiology of diabetic nephropathy. A second phase of the study is expected to commence after the first 16 weeks in order to assess the ability of the dietary factors to modulate atheroma formation and the integrity of drug therapy (upon commencement of treatment)on the prognosis of diabetes. This will be expected to last up to 3 years.
The carbohydrate inulin (from chicory root) is a healthy prebiotic ingredient found in dietary supplements and fortified foods (Nagy et al). Inulin is representative of a broader class of typically health-associated, yet fermentable carbohydrates called fructans that occur naturally in many vegetables, fruits, and wheat. Fructans, or long chains of fructose units, are resistant to human digestive enzyme hydrolysis and transit intact to the small intestine and colon where they undergo rapid fermentation by intestinal microbes. This microbial metabolism of fructans produces gas and other fermentation byproducts that can lead to excess gastrointestinal (GI) symptoms like abdominal bloating, cramping, stomach rumbling, and flatulence (Bonnema et al; Briet et al; Bruhwyler et al), especially in individuals with irritable bowel syndrome (Van den Houte et al). A new digestive enzyme called fructanase was developed to help with GI symptoms associated with fructan consumption. Positive findings from in vitro digestion simulations (Guice et al) and a first-in-human safety trial (Garvey et al) helped define the fructanase dose for this clinical trial-the primary objective of which is to investigate the effect of oral fructanase administration on GI symptoms in healthy adults after consuming oatmeal with added inulin (25 grams). Secondary outcomes include breath hydrogen and methane levels, which serve as biomarkers of intestinal microbial fermentation. The investigators hypothesize that fructanase administration will lower the severity of GI symptoms after inulin consumption, as well as lower breath biomarkers of intestinal microbial fermentation, compared to placebo.
This is a pilot study to test how a growing-up formula (GUF) compares to a common nutritional supplement (NS), which is regularly used to help toddlers (ages 12-36 months) gain weight. This study will look at whether GUF helps to increase solid food intake for children who are thought to be "picky eaters" and see the effects on growth compared with the NS. To date, it is not clear if GUFs help to increase intake of solid foods. Participants will be placed into one of the two study arms: Enfagrow (GUF) or Pediasure (standard NS).
The goal of this study is to determine subjective gastrointestinal tolerance response and differences in breath hydrogen response following the consumption of different types of low FODMAP oral nutrition supplements. This randomized, crossover study requires participants to arrive to the lab 12 hours fasted, consume an oral liquid supplement and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen analysis at various time points over a 4 hour time period.
The investigators propose to study the effects of increased iron intake by home fortification of complementary foods on the gastrointestinal microbial development, inflammatory responses, and zinc (Zn) absorption. The proposed subjects are 9 month olds living in a malaria endemic area of rural Kenya who are randomized at 6 months of age to one of three fortificant groups: 1) Sprinkles™ with 12mg Iron(Fe)/day + other micronutrients, including 5mg/d Zn (test); Sprinkles™ with 0 mg/d Fe + other micronutrients, including 5mg/d Zn (control); Sprinkles™ with no micronutrients (placebo). The investigators hypothesize that the microbiome will be significantly different in the three groups and that Zn absorption and status, in addition to immune and oxidant status will be improved in the non-Fe fortified groups when compared to the Fe-fortified group.
This study was designed to examine changes in capillary blood glucose and venous insulin levels after a 70 gram oral sucrose challenge with and without simultaneous consumption of a dietary supplement containing L-Arabinose and a patented version of chromium (LA-Cr).
More than a dozen states have proposed or plan to implement work requirements in Medicaid, and similar requirements already exist nationally in the Supplemental Nutritional Assistance Program (SNAP), yet evidence on the effects of these policies is limited. In cooperation with the state of Virginia, the investigators plan to conduct a randomized controlled trial studying the impacts of work requirements in public programs on insurance coverage, SNAP participation, employment, and health, with a particular focus on changes in racial/ethnic and geographic disparities in these outcomes. The COVID-19 epidemic and concurrent economic downturn creates additional urgency around these issues, and the investigators will use a combination of national administrative data and a new population survey to assess disparities in employment, health care, and food insecurity during this crisis.
This will be a double blind, placebo-controlled, randomized, counterbalanced, crossover study designed to assess the impact of preloaded betaine supplementation on thermoregulation and exercise metabolism in the heat. The study, outlined in Figure 7 and described in detail below, will consist of seven total visits to the Institute of Sports Science and Medicine (ISSM) or Sandels laboratories at Florida State University, two of which will be experimental visits. On the first visit, participants will be informed as to the details of the study before giving their oral and written informed consent (Appendix A). Thereafter, anthropometrics will be measured and participants will complete an incremental exercise test on an electronically-braked cycle ergometer to volitional exhaustion to determine peak oxygen consumption (VO2 peak). Days 1-6 participants will consume a full dosage of supplementation, whereas day 0 and 7 participants will consume half a dose of the supplement, with the last dosage being consumed 60 minutes prior to experimental visits, days 7 and 21. On days 2 and 4, familiarization trials will be completed to standardize training loads and to reduce any potential learning effect. These visits will be implemented in the heat. On day 7, participants will complete the first experimental trial described in detail below. Afterwards, participants will enter a seven day washout period 167 before crossing over to the second supplemental condition on day 14. On days 16 and 18, participants will undergo the same familiarization trials as they did on days 2 and 4. On day 21, participants will complete their second experimental trial. Each experimental trial will be separated by 14 days. This study will be approved by the Florida State University Insitutional Review Board (Appendix B).