25 Clinical Trials for Various Conditions
Understand the effect of recombinant EPO (rEPO) boosting and microdosing on the hematological module of the Athlete Biological Passport (ABP) * Measure the change in CD71 longitudinally in subjects from both cohorts * Assess whether rEPO administration can be detected in a dried blood spot (DBS) using recent advances in analytical methodologies * Compare windows of rEPO detection using both Athlete Biological Passport models and direct detection using analytical methods in urine, blood, and DBS
Previous work in the area of concussion management has focused heavily on neuro-cognitive testing. In addition to routine neuro-cognitive testing through Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT),this pilot study is designed to establish a comprehensive battery of clinical assessment through the utilization of functional movement and dynamic postural control assessments. The immediate application of these assessments will be focused on the male high school football player (who is at risk for concussion) and both female and male soccer players. Our pilot study aims determine the stability of ImPACT testing in youth athletes in light of ongoing neurodevelopment in this population. In addition, this pilot work will implement additional tools focused on assessment of dynamic balance and gait. This approach will significantly enhance predictions of subsequent musculoskeletal injuries that have been shown to occur in concussed collegiate and professional athletes and that we believe are also occurring in our high school athletes. This battery of tests will provide clinicians with invaluable information to guide both rehabilitation of and return to play (RTP) decisions for concussed high school athletes.
Evaluation of hydration status during exercise and heat exposure.
This is a prospective, randomized, controlled, crossover study to determine the benefits of adult athletes consuming an oral rehydration solution (ORS) with exercise.
The primary objective of this study is to analyze smart phone-based Transdermal Optical Imaging (TOI) features to develop a model that can discern hydration status, including: 1) at various timepoints throughout a 24-hour period in healthy adults from the general population (GENPOP), and 2) before and after a team coach-led training session in athletes competing in a sport (ATHLETE). TOI data will be collected alongside standard reference measures of hydration status. In this study each subject will serve as their own control.
Can nicotinamide riboside (750 mg/day for 12 weeks) affect the levels of NAD+ in the brain as measured by 31P MRS?
The main objectives are to determine sweat sodium concentration \[Na+\], whole body sweat rate (WBSR) and rate of sweat sodium loss (RSSL) in female athletes aged 13 and above during their normal planned training session across various sports (basketball, soccer, volleyball, cheer, flag football and softball).
This research is being done to investigate the dietary supplement, Synaquell (TM), for effects on brain function in youth contact sport athletes.
While the use of creatine monohydrate supplementation and its associated benefits are well researched and supported, the impact of the timing of when creatine is ingested is a highly nuanced topic. The potential for the timing of administration to make an impact on observed outcomes is an established and appreciated factor and limited research to date has examined the impact of creatine timing. Of the literature that has been published, one study was very short in duration (4 weeks) that possessed a study design that undermined its practicality, two other studies used older individuals, and one study utilized a unilateral training model which may not be an adequate exercise protocol to allow for the ergogenic potential of creatine to mediate any enhancement of training adaptations. Therefore, based on the limited number of studies in young and previously trained populations, future studies examining the effects of pre vs post-training creatine monohydrate supplementation on resistance training adaptations are warranted.
Evaluation of increase in body flexibility in female high school athletes undergoing education on nutrition and body image
Sport-related concussion is a common and serious injury that can affect athletes of all ages in any sport. The purpose of this project is to study the effect of a 12-week manual resistance neck strengthening exercise program on participants' neck size and strength and how their heads and necks move during simulated sport-associated tasks. This study will help determine if greater neck strength may lower an athlete's risk of sport-related concussion. Each healthy male and female soccer athlete between the ages of 13-19 enrolled in the study will participate for approximately four months. Study participation includes routine visits with various assessments (i.e. certain body measurements, magnetic resonance imaging, ultrasound) in addition to the strengthening exercise program.
The purpose of this study is to * determine the effects of 12 weeks of HMB free acid gel, ATP, and HMB free acid gel plus ATP supplementation in trained individuals during a periodized training program on skeletal muscle hypertrophy, body composition, strength, force, velocity, and peak power during loaded and unloaded vertical jumps. Additionally, the study will determine if either supplementation protocol prevents the typical decay seen in performance following an overreaching cycle performed in the 9th and 10th weeks of the study. Finally, the study will elucidate the mechanisms of action of supplementation on protein breakdown by analyzing serum indices of muscle damage (CK, LDH) and anabolic status (Testosterone:Cortisol ratio) as well as a urinary indicator of protein breakdown (3-methylhistidine). We hypothesize that under these conditions that the supplementation protocols will augment skeletal muscle hypertrophy, strength, and power and that HMB will blunt increases in serum indices of muscle damage, and urinary indices of protein breakdown.
This research is being done to investigate the dietary supplement, Synaquell (TM), for effects on brain function in youth ice hockey players.
The purpose of this study is to investigate the dietary supplement, Synaquell (TM), for effects on brain function.
Previous work has shown that gelatin supplementation could increase collagen synthesis in humans. In this study subjects consume placebo, 5 or 15 g of gelatin with a standard amount of vitamin C (48 mg) 1 hour before 6 minutes of jump rope exercise. The feeding and exercise intervention was repeated every 6 hours while the subjects were awake for three days and the amount of the amino terminal procollagen I peptide (PINP) was determined; a marker of collagen synthesis, in the blood. Consistent with the hypothesis that gelatin increases collagen synthesis in humans; the amount of PINP in the 15 g gelatin group was significantly higher than either the placebo or the 5 g groups. These data conclusively demonstrate that gelatin supplementation can increase exercise-induced collagen synthesis in humans. Hydrolyzed collagen has a similar amino acid profile, in particular with high concentrations of glycine, proline, hydroxyproline, and arginine. Thus the current study aims to precisely map out the dose response relationship of hydrolyzed collagen and vitamin C on PINP and to determine the optimal dose to achieve maximal increased in PINP levels.
Objective 1: Determine if Vitamin D supplementation can improve body composition, reduce injuries and illnesses, and improve performance in collegiate swimmers and divers. Objective 2: Examine how baseline Vitamin D levels predict outcome variables over the course of the intervention period.
The goal of this clinical trial is to evaluate how different exercise programs alter bone density, structure, and strength in adults. It will also collect data on hormones, factors released from skeletal muscle, and body composition. The main questions it aims to answer are: * Do exercise programs that are frequent with high-impact loading will cause greater improvements in bone health? * What changes in hormones, factors released from skeletal muscle, and body composition contribute to bone adaptations? Researchers will compare different exercise groups to see if the type of exercise influences bone adaptation compared to a recreationally active control group. Participants are asked to: * complete questionnaires, 5 blood draws across the study (3 at rest, 2 after strenuous exercise), dual energy x-ray absorptiometry (DXA) scans (to assess bone mineral density and body composition), high resolution tibial scans to assess bone structure and geometry, and physical performance testing. * attend up to 7 testing visits. * (for those randomized to the exercise training intervention) participate in exercise training sessions for 6 months.
A positive impact of a fermented dairy protein with prebiotic fiber supplement on self-reported GI complaints and wellbeing has been suggested (Wardenaar et al. 2024). The following project aims to further investigate the impact of this supplements in athletes with and without GI complaints in two separate data collections. Part I of the data collection aims to investigate the impact of this supplement vs. a placebo on carbohydrate malabsorption (as a potential cause for GI distress) in athletes that normally don't identify as having GI complaints (randomized double-blind cross over study design covering a total of 9 weeks, including a 3-week washout period). Part II of the data collection aims to confirm the earlier found results in the previous study (Wardenaar et al. 2024) in a group athletes self-reporting GI complaints that will be randomized into an intervention group or a placebo group (randomized double-blind parallel study design covering a total of 3 weeks).
This study is to investigate characteristics of muscle, blood, and urine samples from older adults (ages 65-80) who are either sedentary or athletes performing at an elite level for their age. This observational study will include bio-specimen collection, as well as physical and cognitive function testing and body composition.
Healthy participants with self-reported GI complaints will consume the protein supplement that they normally use for recovery purposes after exercise during a 3-week baseline period, followed by a 3-week intervention period in which they maintain usage of their product, but replace a part of this product with a fermented dairy protein with prebiotic fiber. In addition, a group of healthy participants without self-reported GI complaints will serve as a reference group by consuming the protein supplement that they normally use for recovery purposes after exercise during a 3-week period.
This research study is being conducted to find out how heart function and energy use differ among healthy endurance athletes, individuals who do not exercise regularly, and patients with hypertrophic cardiomyopathy. The research study involves taking part in a cardiopulmonary exercise test (CPET), two positron emission tomography (PET) scans, an echocardiogram, and blood draws. The study will consist of a total of three visits scheduled over a maximum of two weeks. By determining how heart function and energy use differ between our three groups of healthy endurance athletes, individuals who do not exercise regularly, and patients with hypertrophic cardiomyopathy, the investigators hope to have this work translate into a novel clinical tool for differentiating pathologic changes of the heart from physiological changes in heart. This is otherwise known as "gray-zone" left ventricular hypertrophy, or enlargement of the left ventricle.
The primary objective of this study is to collect motion-capture data on movements common to baseball play in order to develop an algorithm for a wearable device for the prevention and rehabilitation of sports-related overuse injuries. Secondary objectives include evaluating the feasibility of wearing the throwing device during simulated baseball play.
Clomiphene (Clomid) is a drug FDA approved to treat female infertility, however, it is often used by men in an off-label setting to both treat male infertility and in a multitude of sports disciplines to increase performance. Study Objectives: * Determine detection windows for clomiphene and its metabolites in urine following a medium-term administration * Understand the effect of clomiphene administration on luteinizing hormone (LH), follicle-stimulating hormone (FSH), and serum testosterone (T) concentrations in a longitudinal manner * Identify changes in current steroidal module of Athlete Biological Passport
A total of 40 subjects will be recruited for participation in this study. 20 subjects (10 males and 10 females) will be randomized to the active group (those receiving re-infusion of autologous blood) and 20 subjects (10 males and 10 females) will be randomized to the placebo group (receiving NS infusion).
Hypothesis: Intranasal administration of exogenous testosterone results in a characteristic profile during anti-doping testing, which is different than the profile seen when testosterone is administered into muscle, on skin or under the tongue. Objective: The investigators aim to characterize the unique steroid doping profile following administration of intranasal testosterone to healthy, active volunteer subjects.