Treatment Trials

24 Clinical Trials for Various Conditions

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COMPLETED
Time-Restricted Eating and Muscle Hypertrophy
Description

The purpose is to examine the effects of time-restricted eating (TRE; consuming all calories within an 8-hour period each day) vs. normal eating (CON; consuming same kcals and protein as TRE, but during a 10-13 hr eating window each day) during 8 weeks of resistance exercise on body composition and muscle mass (whole muscle and single fiber), muscular performance, anabolic protein signaling, single muscle fiber characteristics, and the gut microbiome in well-trained young men and women.

COMPLETED
Skeletal Muscle Hypertrophy and Cardio-Metabolic Benefits After Spinal Cord Injury
Description

Spinal cord injury (SCI) is a devastating medical problem that affects thousands of civilian and military personnel in the United States. Spinal cord injuries (SCI) predispose individuals to impaired fitness, obesity, glucose intolerance and insulin resistance, placing them at greater risk for diabetes and coronary artery disease. These are devastating problems that occur frequently because of changes in body composition and reduced level of physical activity. Skeletal muscle wasting plays a central role in altered metabolism after SCI. Functional electrical stimulation (FES) is an effective rehabilitation tool that has been used to train the paralyzed skeletal muscles and which has shown some ability to ameliorate the deleterious effects of SCI on metabolism, particularly on insulin sensitivity. However, its ability to reverse skeletal muscle wasting is modest; most studies report limited gains in muscle mass and workload with highly variables outcomes from one study to another. This proposal was stimulated by the findings that a program of neuromuscular electrical stimulation resistance exercise prior to initiating functional electrical stimulation lower extremity cycling (FES-LEC) improves the gains in muscle mass and workload observed with FES. The specific objectives for the current proposal are to compare the impact of FES following evoking skeletal muscle hypertrophy of the lower extremity versus initiating FES cycling without introducing the hypertrophy effects on insulin sensitivity, control of blood sugar levels, oxygen uptake and amounts of muscle tissue and fat deposition. These studies could potentially have significant effects on thousands of people that will experience an SCI in the future as well as those living with SCI where prolonged paralysis is a major quality of life issue. There is a major need to investigate the mechanisms lead to maximize the benefits of FES applications and to understand cellular or molecular events that are associated with muscle hypertrophy and lead to promoting metabolic health after SCI. The designed study will provide a greater understanding regarding utilization of energy sources (like fats and sugars) in muscle

COMPLETED
Maximizing Mechanisms of Muscle Hypertrophy to Combat Sarcopenia in Older Adults
Description

Resistance training has shown the most promise among interventions aimed to combat aging muscle atrophy as it enhances strength, power, and mobility function, but induces varying degrees of skeletal muscle hypertrophy as the investigators demonstrated in the initial 5-year funding period of this award (2001-2006). In the subsequent 5-year funding period (2007-2012), the investigators built on this prior work by using a dose-response approach in older adults - ultimately to optimize the treatment of age-related muscle atrophy. The investigators tested four, long-term resistance training prescriptions in older (60-75 yr) women and men to determine which prescription maximizes mechanisms driving muscle regrowth. One of the innovations in this project was the use of a 4-wk pre-training program to reach a plateau in the early, non-muscle mass adaptations, thereby establishing a true baseline from which both mechanisms of measurable muscle hypertrophy and functional consequences of hypertrophy could be studied in a tightly integrated fashion without bias in the subsequent experimental period. A randomized design was used to test the overarching hypothesis that a novel program of mixed strength and power training would optimize the anabolic environment to promote muscle hypertrophy and robust gains in performance. This hypothesis was tested with three specific aims.

COMPLETED
Comparison of 1 vs 3 Sets of Resistance Training on Muscular Hypertrophy
Description

This study is designed to investigate the effects of two levels of resistance weight training on body composition, energy expenditure, and energy intake in men and women. The weight training will take about one hour to complete. Participants will perform the training 3 days per week for 9 months in a private exercise room equipped with state of the art equipment and a personal trainer to help guide you through the exercises. The project lasts 21 months total with one follow-up visit 1-year from your last training date. You will be required to stay in the Lawrence area and train 3 day/week over the summer \& holidays.

Conditions
UNKNOWN
Egg Cholesterol Consumption, Blood Cholesterol and Skeletal Muscle Hypertrophy
Description

The purpose of this study is to examine the effect of dietary cholesterol administered as whole egg or egg white (control)on muscle mass gain with resistance training in a young old population of men and women (age 50-69). It is hypothesized that dietary cholesterol will be significantly associated to muscle mass gain.

COMPLETED
Resistance Training and Milk Supplementation
Description

Post-resistance training high protein milk supplementation may be a viable method to elicit muscular gains. The investigators hypothesis is that high protein milk supplementation would improve skeletal regulatory markers, hormonal responses and body composition in resistance-trained men.

UNKNOWN
Activity Dependent Rehabilitation Model to Improve Bone and Muscle Outcomes
Description

For many after spinal cord injury (SCI) there is immobilization, muscle atrophy, bone loss, fracture risk during transferring (or falls), and the risk of secondary complications, and increase in attendance care and cost. It is important to develop multi dimensional rehabilitation strategies for people after SCI to enhance functional recovery towards walking, and enhance an increase in muscle and bone to potentially prepare the injured nervous system in the event of a cure. Locomotor training (Stand retraining and step re training) an activity-based rehabilitative approach generates muscle activity and provides weight bearing and joint contact kinetics, even in individuals who are unable to stand or step independently. Cross-sectional animal and human SCI studies have demonstrated that locomotor training (LT) (stand retraining and step retraining using body weight support treadmill training) has improved the capacity to stand independently and walk at faster speeds. Neuromuscular stimulation (NMS) or electrical stimulation (ES) training is a rehabilitative approach that generates muscle activity, alternating leg extension and flexion even in individuals who are unable to stand or step independently. NMS studies for individuals after SCI have shown improvements in bone density and muscle strength after cycling and resistance training. The main purpose of this study is to address whether stand retraining and NMS compared to stand retraining alone or NMS alone will increase neural and musculoskeletal gains and provide a greater functional recovery towards independent standing. This project will be completed at two sites: Kessler Foundation Research Center (the grant PI site) and Frazier Rehabilitation Institute, University of Louisville, Kentucky.

COMPLETED
Assessment of the Efficacy of Carnipure® AAS on Body Composition, Muscle Thickness, and Strength Adaptations in Healthy Men
Description

This study is a 12-week randomized active control trial that is investigating the effects of Carnipure(R) AAS on muscle hypertrophy, body composition, and muscular strength adaptations in healthy men performing a resistance training program.

WITHDRAWN
Eccentric Resistance Training With Blood Flow Restriction on Muscle Function
Description

The study will determine the effects of adding blood flow restriction to eccentric training to assess whether this increases the improvements of muscle strength and size.

COMPLETED
Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Young Adults
Description

This study will evaluate the adaptations in skeletal muscle that occur in response to 10 weeks of weight training with or without peanut protein supplementation in untrained men and women ages 18-30

Conditions
RECRUITING
Comparing Two Eccentric Protocols on Muscle Damage
Description

The purpose of this study will be to test whether a new way of weight training is more effective than typical weight training. The investigators expect that this new way will cause more exercise-induced muscle damage, which helps people build bigger muscles. Another purpose of this study will be to explore perceptions of how muscle soreness impacts participant activities of daily living.

COMPLETED
The Environmental Costs of Building Human Muscle
Description

Among the general population, it has been established that plant-based diets confer significant environmental benefits (greenhouse gas emissions, land use, and water use) compared to omnivorous diets. However, sports nutrition recommendations for supporting resistance exercise-induced gains in muscle mass and strength differ substantially from population-level recommendations, especially for protein intake. Therefore the difference in environmental impact between omnivorous and plant-based diets for adults following such recommendations is as yet unknown. A prior analysis found that a high-protein, non-animal-derived diet can support resistance training-induced gains in muscle mass and strength to the same extent as a protein-matched omnivorous diet. These findings align with previous research showing that, in the context of a high-protein diet, the source of protein - whether animal or plant-based - does not affect the rate of resistance exercise-induced gains in muscle mass and strength. The present study therefore plans to retrospectively analyze the diet records from previously published research to determine the difference in environmental impact between the high protein animal-free and omnivorous diets. The findings could highlight the unique difference in environmental impacts between those following high protein plant-based and omnivorous diets.

RECRUITING
EXERT-BCH Exercise Regimen to Improve Muscle Mass After Treatment of Breast Cancer
Description

The purpose of this research study is to evaluate the outcomes of two standard of care group exercise regimens to increase muscle mass in women who have been treated with breast cancer.

COMPLETED
Egg Consumption and Muscular Adaptations
Description

Eggs may be a viable alternative to various types of supplemental proteins given its similar ratings on various measures of dietary protein quality. The investigators hypothesis is that whole eggs would create a greater improvement in skeletal regulatory markers, hormonal responses and body composition than egg white ingestion in resistance-trained men.

Conditions
COMPLETED
The Effects of Lower Extremity Blood Flow Restriction Training on Power, and Muscle Size.
Description

Blood-flow restriction training (BFR) is a technique utilized to provide the benefits of high intensity exercise (strength, power, hypertrophy) when applied to exercise intensities that are insufficient to produce these benefits without BFR. The technique involves the application of an occlusive cuff (similar in design to a blood pressure cuff) over the limb of an individual that is set to occlude arterial blood flow at a given percentage during exercise. BFR has demonstrated increased strength and muscle hypertrophy compared to control interventions in various populations including: healthy subjects, athletes, post-surgery, clinical rehabilitation, and older adults. Most research on BFR has been conducted on single joint exercises and not exercises that exhibit more complex movements typically associated with daily activities. The early evidence of complex exercises combined with BFR suggests that strength and hypertrophy both improve, however more research needs to be conducted. The purpose of this project is to determine if four weeks of BFR training combined with approach rowing and deadlifts increases strength, power, aerobic capacity, and muscle size. These results will be compared to an isovolumetric control.

Conditions
COMPLETED
Food First Approach to Stimulate Muscle Protein Synthesis in Healthy Adults
Description

In a crossover design 10 young healthy adults (20-35 y) will receive stable isotope tracer infusions and perform a single bout of resistance exercise. Immediately after exercise participants will ingest either 3.5 oz of Salmon fillet or its constituent macronutrients as isolated amino acids and fat. Repeated blood and breath samples as well as muscle biopsies will be collected to determine whole body amino acid kinetics, muscle amino acid transporters, anabolic signalling and myofibrillar protein synthesis rates during the trials

Conditions
COMPLETED
BFR and Muscle Mitochondrial Oxidative Capacity
Description

Blood flow restricted (BFR) exercise has been shown to improve skeletal muscle adaptations to resistance exercise. BFR uses blood pressure cuffs (i.e., tourniquets) to reduce skeletal muscle blood flow during resistance exercise. One benefit of BFR is that skeletal muscle adaptations to resistance exercise training including muscle hypertrophy and increases in strength can be achieved at lower-loads (e.g., 25-30% 1RM), that are often comparable to more traditional resistance training loads (70-85% 1RM). However, the impact that low-load BFR resistance exercise has on muscle quality and bioenergetics is unknown. The present study will examine the impact of 6 weeks of low-load, single-leg resistance exercise training with or without personalized BFR on measures of muscle mass, strength, quality, and mitochondrial bioenergetics. The investigators will recruit and study up to 30, previously sedentary, healthy, college-aged adults (18-40 years). The investigators will measure muscle mass using Dual Energy X-Ray Absorptiometry and muscle strength and endurance using isokinetic testing. The investigators will normalize knee extensor strength to lower limb lean mass to quantify muscle quality. The investigators will also use near infrared spectroscopy (NIRS) to measure mitochondrial oxidative capacity in the vastus lateralis. Finally, the investigators will measure markers of systemic inflammation and markers of muscle damage using commercially available ELISA assays.

COMPLETED
Muscle Protein Synthesis After Whole Egg vs. Egg White Consumption
Description

In crossover trials, ten (N=10) young men (18-35 y) will receive stable isotope tracer infusions and perform a single bout of resistance exercise. Immediately after resistance exercise, participants will ingest stable isotope labeled whole eggs (18 g protein, 17 g fat) or egg whites (18 g protein, 0 g fat) cooked in scrambled form. Repeated blood and muscle biopsies will be collected to determine whole body amino acid kinetics, muscle amino acid transporters, anabolic signaling and myofibrillar protein synthesis rates during the trials.

Conditions
COMPLETED
Effects of Increased, Egg-Based Protein Intake on Muscle Composition,
Description

This study is designed to assess the effect of a diet-controlled nutrition program utilizing an egg-based higher protein diet on muscle composition and size, and indices of metabolic health and markers of systemic inflammation in older men and women who are slightly overweight.

COMPLETED
Novel Intervention to Influence Muscle Plasticity in Veterans
Description

The loss of muscle contraction (paralysis) removes an important stimulus for maintenance of overall health for individuals with complete spinal cord injury (SCI). Increased protein catabolism (atrophy) limits important stresses to the skeletal system. Bone loss doubles the risk of fracture and contributes to increased mortality in Veterans with SCI. Metabolic syndrome and diabetes lead to heart disease in Veterans with SCI at higher rates than the general population. Exercise methods to sustain muscle tissue, bone density, and metabolic stability after SCI are lacking scientific justification. If left unchecked, the secondary complications of SCI can be health limiting or even life threatening to Veterans with paralysis. The importance of maintaining the health of the musculoskeletal system after SCI has never been greater as a cure for paralysis may become a reality. Contemporary rehabilitation interventions lack the ability to functionally load muscle tissue, quantify the dose of load, stress the cardiovascular system, monitor the overall stresses during daily exercise training, or offer portability to improve compliance with the exercise. The long-term goal of this project is to establish the optimal dose of muscle and bone stress during functional exercise in order to improve the health of Veterans with complete paralysis. The practical outcome of this research is to offer a form of activity that is feasible, portable, and grounded in sound scientific principles. The scientific goal is to understand whether the dose of force generated in paralyzed muscle via evoked contractions is critical to muscle atrophy/hypertrophy molecular pathways, physiologic performance, and insulin sensitivity. The investigators will administer various doses of muscle force by manipulating the frequency of electrical stimulation while keeping stimulation current (i.e. muscle fiber recruitment) constant. Interestingly, no previous study has examined the dose of muscle force necessary to trigger adaptations in protein synthesis/degradation pathways. The investigators wish to discover the most effective method to maintain the molecular and physiologic properties of paralyzed muscle. The investigators believe such a method will be in urgent demand as a co-intervention with pharmaceutical strategies in post-SCI rehabilitation.

COMPLETED
5-Alpha Reductase and Anabolic Effects of Testosterone
Description

The purpose of this study is to determine whether a higher-than-replacement dose of testosterone and finasteride can be combined to safely increase muscle strength in older men who have a low blood concentration of testosterone.

COMPLETED
Study on the Effects of Sacubitril/Valsartan on Physical Activity and Sleep in Heart Failure With Reduced Ejection Fraction Patients.
Description

The purpose of this study was to investigate the effects of initiation of sacubitril/valsartan vs enalapril treatment on objective measures of both waking activity and sleep in subjects with heart failure with reduced ejection fraction.

COMPLETED
Metformin to Augment Strength Training Effective Response in Seniors (MASTERS)
Description

The purpose of this study is to determine whether a commonly prescribed drug, metformin, can enhance the benefits seen during resistance exercise such as increased muscle mass and strength.

Conditions
COMPLETED
Genetic Analysis of African-Americans With High Blood Pressure
Description

The purpose of this study is to learn if kinase, a protein found in the heart, contributes to thickening of the heart muscle in people with high blood pressure. A protein called myosin causes the heart to contract and relax. It is thought that kinase changes myosin to make it work better at different heart rates. This study will try to determine if, in some people with high blood pressure, the different forms of this protein cause changes in the heart. If the protein affects the size of the heart, it might be possible to use it to improve heart function after an injury, such as a heart attack. African-Americans with high blood pressure will be eligible for this study. Current data show that of almost 900 multi-ethnic individuals, the particular form of kinase under study in this project is found exclusively in the African-American population. Study participants will have two tubes of blood drawn for DNA testing to determine what form of kinase is present. An electrocardiogram will also be done if a recent one is not available. Some people may also have an echocardiogram, an ultrasound test to image the heart.

Conditions