Treatment Trials

41 Clinical Trials for Various Conditions

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COMPLETED
Chronic Study on Body Composition, Training, Performance, and Recovery
Description

The chronic phase of the study will evaluate the effects of pre-exercise and post-exercise ingestion of a multi-ingredient supplement on adaptations to a 6-week exercise program consisting of both resistance training and high intensity aerobic exercise, using a randomized, double-blind, placebo-controlled design. Participants will complete an enrollment/familiarization visit, a baseline testing session, followed by a 6-week supervised exercise intervention, and post-testing session identical to baseline testing. Participants will be randomized during the baseline session to groups receiving either 1) Active Treatment (pre-post supplementation), 2) placebo (noncaloric beverage), or 3) control, not participating in exercise or consuming a treatment. During the supervised 6-week resistance training program, participants will complete a moderate-intensity warm-up, a full-body resistance training workout (2 x per week) and an interval training session (1 x per week). Thirty-minutes prior to each training session, and within 15 minutes post-exercise, participants will consume their randomly assigned treatment beverage. Body composition, blood markers of muscle damage/recovery, strength, and performance tests will be measured before (baseline) and after training (Post) to evaluate the effects of supplementation. All data collection will be conducted by the Principal Investigator and Research Assistants. All subjects will report to the Applied Physiology Laboratory and Human Performance Center in Fetzer Hall for all testing and training sessions, which will span approximately 8 weeks.

COMPLETED
Acute Study on Muscle Soreness, Damage, and Performance
Description

The acute study will evaluate pre- and post-exercise ingestion of a multi-ingredient supplement in a randomized, double-blind, placebo-controlled, crossover design. Participants will complete one enrollment visit, in which they will sign a consent form and complete a health history questionnaire. Participants will complete two interventions, with three visits each (6 visits total), in which a treatment beverage (pre/post supplement, or non-caloric placebo) will be consumed within 30 minutes prior to exercise and within 15 minutes post-exercise, in random order. Total time from enrollment to completion will be at least 14 days. Testing visits will be separated by a minimum of 7 days of rest to allow for recovery and washout, based on a half-life of ≤8 hours for all ingredients present in the supplement.

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
Effects of Pea Proteins on Muscle Damage and Recovery
Description

This study is a double-blind, randomized, placebo-controlled, crossover clinical trial of N=40 recreationally active men to be recruited a single investigational center in Ohio (i.e., The Center for Applied Health Sciences). Subjects will take a daily protein supplement (e.g., 15 g of pea protein or 15 g of pea protein + probiotic blend) for 4 weeks, have a 1-week washout period (i.e. meaning they will not take either supplement), and then take the alternate protein supplement for an additional 4 weeks. Outcome variables include plasma amino acids, muscle damage, muscle recovery, and GI tolerance.

COMPLETED
The Effects of Whey Protein Supplements on Markers of Exercise-induced Muscle Damage in Resistance-trained Individuals
Description

Intense exercise can bring about various side effects to one's body. Less range of motion, increased pain sensitivity, increased muscle swelling, and decreased muscle strength can occur immediately after exercise. These side effects can be referred to exercise induced muscle damage (EIMD) and can sometimes last many days. This study's goal is to evaluate the effects of various protein supplements on EIMD symptoms as well as on blood vessel health during the recovery period after muscle damaging exercise.

COMPLETED
Turmeric and Exercise-Induced Muscle Damage and Oxinflammation
Description

The purpose of this study is to measure the effect of using a turmeric-based supplement for 2-weeks on muscle damage and soreness that occur in the body after 90-minutes of exercise. Participants will first come to the human performance lab (HPL) for orientation and pre-study fitness tests including muscular fitness and body composition. Participants will be randomized to turmeric or placebo groups, and take 2 tablets of the supplements each day for the first two weeks. Participants will report back to the HPL on a Monday to engage in weight lifting and calisthenics for 90 minutes. Fitness tests (vertical jump, bench press, leg-back lift for strength, 30-second cycling sprint test) and blood samples will be given and collected before and after this exercise session. Participants will then come back to the HPL each morning, Tuesday through Friday, in the early morning to provide blood samples and retake the fitness tests. This study will entail seven HPL visits over a 3-week period.

Conditions
COMPLETED
Effectiveness of Two Different Forms of Marine Oil on Indirect Markers of Muscle Damage and Soreness in Untrained Men
Description

To evaluate the effects of PCSO-524®, and a blend of PCSO-24® (75%) and krill oil (25%) (ESPO-572®), on indirect markers of muscle damage, inflammation and soreness during recovery from muscle damaging exercise in untrained men.

COMPLETED
Study to Determine if the Flu Vaccine Increases the Risk of Muscle Damage in Participants Taking Drugs That Block Certain Proteins Made by Some Types of Immune System Cells
Description

A retrospective, observational study conducted on cancer patients receiving a drug that blocks certain proteins made by some types of immune system cells

Conditions
COMPLETED
Pea Protein Supplementation and Muscle Damage
Description

The purpose of this study is to determine if supplementation with NUTRALYS pea protein isolate compared to whey protein and apple juice (carbohydrate, non-protein control) before, during, and after a 90-minute bout of eccentric exercise can attenuate exercise-induced muscle damage, inflammation, and delayed onset of muscle soreness (DOMS), and speed recovery of muscle function.

Conditions
COMPLETED
Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males
Description

This is a randomized, repeated measures and double blind study which measures the effect of fenugreek extract on markers of muscle damage and inflammation in non-resistance trained males. Participants will complete baseline testing and then be randomized into groups. Participants will complete a 2 week, split-body resistance training program. They will then return for testing in which they will complete an overreaching protocol for 5 consecutive days. Measurements will be recorded 24 hrs after the fifth day. Participants will resume the training program for one additional week and return for final measurements.

RECRUITING
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Description

Peripheral artery disease (PAD) is a manifestation of atherosclerosis that produces progressive narrowing and occlusion of the arteries supplying the lower extremities. The most common clinical manifestation of PAD is claudication, i.e., a severe functional limitation identified as gait dysfunction and walking-induced leg muscle pain relieved by rest. The standard therapies for claudication include the medications cilostazol and pentoxifylline, supervised exercise therapy and operative revascularization. Recent data demonstrated that 24 weeks of treatment with the angiotensin-converting enzyme (ACE) inhibitor Ramipril produces improvements in the walking performance of patients with claudication that are higher than those of cilostazol and pentoxifylline and similar to those produced by supervised exercise therapy and operative revascularization. The mechanisms by which Ramipril therapy produces this impressive improvement in the functional capacity of claudicating patients remain unknown. The Investigators hypothesize that treatment of claudicating PAD patients with Ramipril will improve walking performance and quality of life by improving the myopathy of the gastrocnemius. Improved myopathy is a consequence of reduced oxidative damage, reduced TGF-β1 production by vascular smooth muscle cells and reduced collagen deposition in the affected gastrocnemius.

COMPLETED
The Effects of Probiotic Supplementation on Markers of Muscle Damage and Performance Following Exercise Induced Muscle Damage
Description

To determine the effect of probiotic supplementation on the inflammatory response and subsequent performance following a muscle damaging exercise bout, a double-blind, randomized placebo controlled two-factor repeated measures design will be employed. The dependent variables for this study will include measures of performance as well as markers of inflammation in a single limb model. Participants who qualify for study participation will have their height, weight, and body composition assessed (skin fold) followed by baseline measurements for determination of isometric and dynamic strength. Initial limb will be determined randomly. Following baseline testing, participants will randomly be assigned to ingest either a probiotic or placebo. Supplementation will begin at least 24 hours post baseline testing. Twenty-one days after initiating supplementation, participants will again complete performance testing followed by an exercise bout known to elicit muscle damage and produce an inflammatory response. Participants will then repeat performance testing 24, 48, and 72 hours post muscle damaging bout. Blood samples for determination of markers of inflammation will be taken throughout study duration. Following a 3-week wash-out period (21 days), participants will repeat the experiment following the alternate supplement regimen with the contralateral limb.

Conditions
COMPLETED
GSK1278863 Effects on Eccentric Exercise-Induced Muscle Damage
Description

As per non-clinical studies, prolyl hydroxylase inhibitor GSK1278863 can protect muscle from unaccustomed exercise induced muscle damage and enhance functional muscle repair. This study is designed to investigate arm function, pain and other pharmacodynamic (PD) markers after unaccustomed maximal eccentric exercise with concurrent administration of GSK1278863 or placebo. Primary objective of the study is to evaluate the protective effects of GSK1278863 on eccentric exercise induced muscle injury. Subjects will be randomized in a 1:1 ratio (1 subject on GSK1278863 for every 1 subject on placebo). Each subject will be given five oral doses of GSK1278863/placebo in total. The first dose will be administered immediately after completion of eccentric exercise and then 4, 8, 24, and 48 hours later. Subjects will be housed till day 4 in unit and will return for a follow-up visit 7-10 days after discharge. After enrolment of approximately 30 subjects, enrolment will be paused and planned interim analysis will be performed to decide whether to terminate enrolment/study, continue dosing or to reduce the dose to 5 milligrams (mg).

Conditions
COMPLETED
Protein and Recovery From Exercise-induced Muscle Damage
Description

Intense, eccentric resistance exercise causes muscle damage, soreness, inflammation, and a loss of muscle function. Protein-amino acid supplementation before, during, and following damaging resistance exercise may reduce muscle damage and accelerate recovery. This study will determine if supplementation with Herbalife 24 Rebuild Strength (compared to placebo) before, during, and after a 90-minute bout of eccentric exercise attenuates exercise-induced muscle damage, inflammation, and delayed onset of muscle soreness (DOMS), speeds recovery of muscle function, and maintains immune function in NASCAR pit crew athletes (Hendrick Motor Sports).

COMPLETED
Vitamin D2, Muscle Damage, NASCAR Pitcrew
Description

Hypothesis: Six weeks of supplementation with vitamin D (4000 IU/day) using Dole's Vitamin D Portobello Mushroom Powder will increase winter serum vitamin D levels, and improve muscle function and strength, and innate immunity (granulocyte/monocyte phagocytosis and oxidative burst activity), and attenuate exercise-induced muscle damage and DOMS.

COMPLETED
Comparison of Pre-exercise Beta-hydroxy-beta-methylbutyrate Free Acid (HMB-FA) and Cold Water Therapy for the Attenuation of Muscle Damage and Soreness
Description

Study Objectives 1. Compare beta-hydroxy-beta-methylbutyrate free acid (HMB-FA) to cold water immersion on performance recovery from an acute bout of high intensity resistance exercise. 2. Compare HMB-FA + Cold water immersion to HMB-FA or cold water immersion. 3. Examine the effect of these recovery modalities on markers of muscle damage, inflammation and immune function. Subjects Subjects (men and women, 18 - 35 y) with at least one year of resistance training experience will be recruited. Subjects will be randomly divided into one of four groups: a cold water immersion group (CW), HMB-FA, CW+HMB-FA and a control group (CT). Study Protocol Subjects will report to the Human Performance Laboratory (HPL) on four separate occasions. On the first visit (T1) subjects will be tested for maximal strength \[one repetition-maximum (1-RM)\] on the squat, dead lift and barbell lunge exercises.\] On their second visit (T2) subjects will perform a lower body resistance exercise session consisting of four sets of the squat, dead lift and barbell lunge exercises. All subjects will then report back to the HPL at 24- (T3) and 48-hours (T4) post-exercise. During T3 and T4, subjects will perform four sets of the squat exercise only using the same loading pattern and rest interval length as T2. Following the T2 and T3 workouts subjects in CT will undergo no treatment; subjects in CW will be required to sit in a whirlpool tub for 10-min up to their umbilicus in water at 50° F - 54° F (10° C - 12° C); subjects in HMB-FA will be provided the supplement 30 min prior each workout and CW+HMB-FA will be administered together at time points describe above. Statistical Analysis Statistical evaluation of performance and biochemical changes will be accomplished using a repeated measures analysis of variance (ANOVA).

Conditions
COMPLETED
Efficacy of Tart Cherry Juice in Reducing Muscle Injury and Biomarkers of Muscle Damage Among Healthy Adults
Description

The purpose of this study is to assess the effects of tart cherry juice to reduce serum biomarkers of inflammation and reduce muscle soreness in healthy adults who undergo a bout of controlled eccentric exercise.

RECRUITING
The Effect of Vicia Faba Hydrolysate Supplementation on Muscle Strength Recovery
Description

To investigate the effect of Vicia faba protein concentrate, a protein derived from Fava bean extract, on delayed onset muscle soreness (DOMS). Participants receive either 2.4g/day of PeptiStrong® supplement capsules or placebo capsules for 14 days until a strenuous exercise session. For the last 3 days, 2/3 of them stay on the same treatment and 1/3 of them switch from placebo to PeptiStrong®.

ACTIVE_NOT_RECRUITING
HIFEM and Radiofrequency for Muscular System Function Improvement
Description

The goal of this clinical trial is to investigate the effect of the BTL-899M device on muscular system function in adult subjects seeking treatment for improving their muscular system function in the lower extremities. The main question it aims to answer is: Whether the BTL-899M device is effective for muscular system function improvement 3 months posttreatment compared to the sham group, based on the dynamometer measurement. Researchers will compare a sham group to see if the device is effective. Participants will complete four treatment visits and two follow-up visits. Their strength will be recorded via a dynamometer.

RECRUITING
Solarplast (R) Supplementation Effects Following High-intensity Resistance Exercise
Description

The primary goal of this investigation is to assess whether Solarplast (R) supplementation will improve recovery following heavy resistance exercise in active adults. The primary questions to be addressed are: Does Solarplast (R) decrease muscle damage and inflammation associated with heavy resistance exercise? Does Solarplast (R) reduce the decline in performance associate with heavy resistance exercise? Researchers will compare Solarplast (R) to a placebo (a look-alike substance that contains no active ingredients) to see if Solarplast (R) is effective at improving recovery. Participants will be asked to: Take Solarplast (R) or placebo daily for 4 weeks Visit the laboratory at least once per week to receive their supplement Report to the lab for 3 consecutive visits following supplementation to complete a heavy resistance training session and follow-up testing.

Conditions
WITHDRAWN
Topical Cannabidiol Cream and Post-exercise Recovery
Description

This proposal's objective is to investigate the effects of topical cannabidiol (CBD) cream on exercise-induced muscle damage, exercise-induced inflammatory markers, and subsequent exercise performance after an exercise-induced damage protocol.

Conditions
COMPLETED
Water Oxygenation and Brain Activity
Description

The primary purpose of this interventional, placebo controlled, crossover, double blind, basic science exploratory study is to investigate whether there is a difference in brain electrophysiological oscillatory activity in healthy adults before and after oral consumption of water containing very small bubbles of oxygen (electrokinetically modified water).

Conditions
COMPLETED
Effect of Compression Garments on Exercise Performance Following Acute High Intensity Exercise
Description

To examine the influence of compression garments manufactured with Far-Infrared technology on exercise performance during and after repeated eccentric isokinetic muscle actions of the leg extensors.

Conditions
COMPLETED
The Effects of High Dose Fish Oil Supplementation on Delayed Onset Muscle Soreness and Inflammatory Markers
Description

The purpose of this study is to determine the effects of fish oil supplementation (Lovaza, GlaxoSmithKline) on muscle strength, muscle soreness and inflammation following exercise.

NOT_YET_RECRUITING
A Randomized, Double-Blind Study to Assess the Effect of a Postbiotic on Oxidative Stress and Exercise Performance
Description

This is a prospective, randomized, placebo controlled, double-blind study to assess the effects of a postbiotic blend on exercise induced oxidative stress markers and exercise performance in healthy adult.

COMPLETED
Impact of Powdered Tart Cherries on Recovery From Repeated Sprints
Description

The purpose of this study is to evaluate changes in force and power production, soreness, inflammation, and oxidative stress after repeated sprinting activity and powdered tart cherry ingestion in trained males and females.

COMPLETED
Immune and Recovery Modulating Impact of Probiotic Supplementation After Intense Resistance Exercise
Description

This study proposal seeks to examine the efficacy of probiotic supplementation at mitigating changes in immune function and recovery after completion of intense, stressful exercise while also allowing for a better understanding of its ability to promote recovery and maintenance of physical performance.

COMPLETED
The Chronic Effects of Carnitine on Recovery
Description

This study investigated the effects of CarnipureTM, a high-quality L-carnitine ingredient, on long term (5 weeks) recovery, muscle damage, and SOD status in a population of males and females while training two days per week. The primary outcomes defining recovery were changes in serum creatine kinase levels and perceptual changes in recovery. Supporting variables included an assessment of strength and power as a functional indicator of recovery. This study would be the first to examine the effects of CarnipureTM on long-term recovery. Our primary hypothesis was that L-carnitine supplementation would reduce muscle damage and improve perceptual measures of recovery. Our secondary hypotheses were that L-carnitine supplementation would better sustain strength and power and elevate SOD status.

COMPLETED
The Short Term Effects of Oceanix Supplementation on Recovery
Description

The purpose of this study will be to examine the effects of Oceanix supplementation on isometric mid-thigh pull force kinetics and salivary immunoglobulin A (indice of immune function) following a one-week intense resistance training protocol. The study will be carried out in a randomized, double-blind, placebo-controlled, parallel manner. Subjects will be stratified into quartiles based on peak force achieved in the isometric mid-thigh pull assessment during screen and prior to baseline testing. Subjects from each quartile will be randomly divided by into treatment and or placebo conditions. Following randomization, subjects will be baseline tested on isometric mid-thigh pull and salivary immunoglobulin A. Following baseline testing, subject will be given their respective supplement conditions and will be instructed to consume one serving (25mg) a day for 21 consecutive days. For days 1 through 14 subjects will be asked to refrain from resistance training. Subjects will undergo a five day intense resistance training protocol will on day 15 to day 19. Subjects will complete follow-up testing in a manner identical to baseline on day 20 and 21 (24- and 48-hours post completion of the training protocol).

COMPLETED
The Effects of Antioxidant Supplementation on Multiple Endurance Race Performance, Physiology, and Recovery.
Description

Thirty active male and female athletes will be recruited for the study. Subjects will be examined at baseline for VO2max performance. Subjects will then be stratified and randomly divided equally (50% - 50%) into an Oceanix (supplemental) or placebo condition such that baseline VO2max match. Once randomization, subjects will be baseline tested for multiple measures of muscle force capacity, muscle soreness, immune function, and endocrine function. Upon completion of baseline testing, subjects will all complete a one-day, cross-training course in Tampa, Florida. The training course is known to be extremely vigorous and causes significant muscle damage. Subjects will then be retested for muscle function at 24, and 48 hours following the course. At 24- and 48-hours subjects will be asked to repeat a simulated time trial race. In this way, we will measure repeated race performance, recovery from intense exercise, muscle damage from exercise, and immune function during multiple races.