Clinical Research Directory

A Study of the Effect of (S)-Pindolol Benzoate (ACM-001.1) on Lean Body Mass (LBM) in Obese Patents During (PROACT 1), and Post-semaglutide Therapy (PROACT 2)

Semaglutide is approved for weight management (weight loss and weight maintenance) in adult obese patients. Drug treatments like semaglutide that result in weight-loss can also decrease muscle mass. The purpose of this study is to investigate the effect of ACM-001.1 (the study drug) on how much muscle is lost when a person takes it with semaglutide (PROACT 1) and how much muscle mass is gained when a person continues taking ACM-001.1 but stops taking semaglutide (PROACT 2).

Ultrasound Detection of Body Composition in Critical Care

Objective assessment of the Changes in body composition of critically ill patients is very valuable. Ultrasound stands as a solution due to its portability, bedside availability, and radiation-free technology. Those criteria are crucial for critically ill obstetrics and gynecological cases.

Preventing Muscle Loss After Bariatric Surgery: Protein-Collagen Supplementation and Resistance Exercise

The aim of this clinical trial is to investigate the effectiveness of collagen, considered a new approach to prevent muscle mass loss after bariatric surgery, and to demonstrate the relationship between this effect and exercise. The key questions it aims to answer are: Does whey protein supplementation with collagen combined with resistance exercise prevent muscle mass loss after bariatric surgery? Do whey protein supplementation with collagen combined with resistance exercise affect fat mass after bariatric surgery? Researchers will compare collagen with whey protein. The study groups and interventions to be implemented are summarized below: Group 1: Control Group (CG; n: 10) Whey protein supplementation will be administered Vitamin and mineral supplementation will be administered No resistance exercise will be performed The participants will eat according to bariatric surgery nutrition guidelines and perform physical activities. Group 2: Whey Protein + Collagen + Exercise Group (WPCEG; n: 10) Whey protein supplements with collagen will be given. Vitamin and mineral supplements will be given. Resistance exercise will be performed. They will eat according to bariatric surgery nutrition guidelines and perform physical activities. They will begin a resistance exercise program 4 weeks after surgery. Group 3: Whey Protein + Collagen + No Exercise Group (WPCG; n: 10) Whey protein supplements with collagen will be given. Vitamin and mineral supplements will be given. No resistance exercise will be performed. They will eat according to bariatric surgery nutrition guidelines and perform physical activities. Group 4: Whey Protein + Exercise Group (WPEG; n: 10) Whey protein supplements will be given. Vitamin and mineral supplements will be given. Resistance exercise will be performed. They will eat according to bariatric surgery nutrition guidelines and perform physical activities. A resistance exercise program will begin at 4 weeks post-operatively.

Mortality and Muscle Mass Loss in Critically Ill Patients.

The aim of the study is to monitor changes in muscle mass in critically ill patients and to verify whether a decrease in muscle mass of ≥10% during the first 7 days of hospitalization is associated with increased 28-day mortality. We will be used ultrasoud for measurement the rectus femoris cross sectional area.

CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis

Study is looking at the effects of cystic fibrosis treatment on bone muscle.

Examining the Effects of Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes.

This is a 12-week randomized, controlled trial that seeks to examine the effect of Vivo on 1) change in lower extremity strength defined as number of chair stands done in 30 seconds and 2) change in average glycemic level (HbA1c) compared to a wait list control.

Testing LiverWatch, a Home-Based Remote-Monitoring Intervention for Advanced Liver Disease

Remote healthcare monitoring for cirrhosis has shown promise in overcoming barriers to accessing specialty care, improving healthcare quality, and reducing mortality. The LiverWatch study is investigating whether a remote nutrition, physical activity, and education intervention can improve health outcomes in those with cirrhosis. In this clinical trial, individuals will be randomized to either enhanced usual care or the LiverWatch intervention. Both groups are given fitbits and asked to increase their step counts. Those in the Liverwatch group will be incentivized for increase their physical activity while also undergoing a personalized nutrition intervention and weekly symptom monitoring and cirrhosis education.

Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men

Men sustain over one-third of osteoporosis-related fractures worldwide. The burden of osteoporotic fractures in older men is substantial, and men suffer significantly worse fracture-related outcomes than women. Following a fracture, men sustain greater rates of subsequent fractures, loss of autonomy, and mortality than women and the imminent risk of re-fracture is several times higher in men than in women. Functional mobility, known to predict falls and fractures, is also notably worse in men following a fracture. In the fiscal year 2007-08, the overall annual costs of osteoporosis in Canadian men was evaluated to be $910 million. Osteoporosis is primarily considered a disease of older women, and men are remarkably under-evaluated and under-treated for it. Recognition of sex and gender influences on skeletal health in men has been very slow; akin to the gap in cardiovascular diseases, where women are far less likely to receive guideline-recommended investigations and treatment. Over 85% of Canadian men who suffer from fragility fractures do not receive osteoporosis screening and/or treatment strategies. The existence of this care gap in men underscores our current struggle to overcome important barriers including: 1) men's lack of awareness of the critical impact of osteoporosis and fractures on several aspects of their lives, and of the benefits of treatment; and 2) the absence of comprehensive and accessible treatments tailored to men. Informed by the Knowledge-to-Action framework, we aim to address these barriers by adapting interventions with proven efficacy to engage men at high fracture risk in health behaviour change. The current protocol is for a pilot RCT to determine the feasibility of recruitment and retention, adherence to, and acceptability of the virtually-delivered fracture prevention intervention only. Our long-term goal is to conduct a large pragmatic randomized controlled trial (RCT) to address the research question: In older adults at high risk for fractures who self-identify as men, does anti-osteoporosis pharmacotherapy in conjunction with a virtually-delivered intervention that includes a gender-tailored strength training and balance based exercise program and nutritional counselling, improve functional mobility compared to anti-osteoporosis pharmacotherapy in conjunction with an attention control intervention.

Plant vs Animal-based Protein Sources as an Anabolic and Metabolic-protective Options for SO in Older Adults

This study is testing how different types of protein - from red meat, legumes (like lentils and beans), or a mix of both - affect muscle strength, body composition, and metabolic health in older adults with obesity who are also at risk for sarcopenia (loss of muscle mass and function). Participants will follow a personalized weight loss diet with one high-protein meal each day that includes either red meat, legumes, or both, along with a home-based strength training program. The study will last three months and will include health assessments such as blood tests, muscle and fat measurements, and physical function tests. The goal is to find out which type of protein source is most helpful for improving strength, reducing body fat, and supporting healthy aging.

Testosterone in Bariatric Patients

Bariatric surgery is an effective method in the treatment of severe obesity and type 2 diabetes mellitus achieving high remission rates. However, weight loss also causes loss of skeletal muscle and bone mass which at least partly could be prevented by exercise and dietary intervention although the counselling of obese and sedentary individuals in order to increase their physical activity presents a challenge. As up to 78.8% of men undergoing bariatric surgery have low levels of testosterone, testosterone therapy could be considered an attractive alternative or supplement to prevent the immense loss of muscle mass during weight loss. Furthermore, low testosterone levels are associated with sarcopenia, insulin resistance, increased body fat, reduced quality of life, loss of libido and reduced sexual function. The study is a long-term randomized, placebo-controlled trial investigating the effects of testosterone therapy combined with exercise and diet counselling on body composition, components of the metabolic syndrome, hormones, inflammation, sexual function and quality of life before and after weight loss in obese, hypogonadal men undergoing bariatric surgery.

D3-Creatine and Skeletal Muscle in Older Adults

The age-related decline in muscle mass and strength are collectively referred to as sarcopenia. However, the tools currently employed to assess skeletal muscle mass (SMM) (e.g., Dual-energy Xray Absorptiometry; DXA) have substantial drawbacks, and it is known that DXA-lean soft tissue (LST) is generally not associated with health outcomes of interest. Thus, the investigators propose using a novel, non-invasive, stable isotope-labelled probe (Deuterium (D)-labelled creatine (D3-creatine; D3-Cr)) to measure skeletal muscle mass in a large cohort of older individuals. The development and employment of new methods to accurately quantify the biological substrate of sarcopenia, skeletal muscle, are critical for the measure to remain clinically relevant. The plan is to measure 350 persons from the recently established (M3) prospective cohort. There will be measurement of lean soft tissue LST and appendicular LST (aLST) using DXA and compared to D3-Cr-measured SMM (D3-Cr-SMM) at baseline, 12mo, and 24mo (2yr) of follow-up. Physical mobility will also be measured (using various instruments).

Branched Chained Amino Acid Supplement in Patients Undergoing Lower Limb Bone Cancer Curettage for Bone Metastasis

Postoperative muscle loss is common in patients with bone metastases undergoing lower limb bone cancer curettage, affecting both limb skeletal muscles and potentially swallowing-related muscles. Rectus femoris thickness, measured via ultrasound on postoperative day seven, is used to assess this loss. Branched-chain amino acids (BCAAs) are important for muscle protein synthesis, but little research exists on whether postoperative oral BCAA supplementation can reduce muscle loss, swallowing function deterioration, and short-term complications. This study investigates if BCAA supplementation from postoperative day one to day 30 can reduce muscle loss (primary endpoint: rectus femoris thickness on day seven) and mitigate swallowing function decline, pharyngeal muscle contraction loss, and complications within three months post-surgery.

KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting

A physiological human nutrition includes circadian feeding and nighttime fasting during sleep. There is increasing evidence, that this natural fasting episode over nighttime majorly contributes to repair processes of the human body. So far, intensive care patients are normally enterally fed continuously, so that there is no circadian nutrition and no nighttime fasting. An enteral nutrition for 12 hours followed by a fasting period of 12 hours supported by exogenous ketone salts potentially improves the reconstitution of ICU patients compared to ICU patients who are continuously enterally fed.

ImpACt of Very High Protein Content Enteral nUtrition Formulas on Critically Ill MUltipLe trAuma paTiEnts

This prospective observational randomized study aims to determine energy, protein intake and gastrointestinal tolerance while using enteral nutrition formulas with very high protein content and enteral nutrition formulas with normal protein content. * Differences regarding achieving protein and calorie daily targets when using enteral nutrition formulas with different protein content * Differences regarding residual gastric volume when using enteral nutrition formulas with different protein content * Differences regarding body composition when using enteral nutrition formulas with different protein content

Comparison of Computed Tomography Data With Routine Measurements Concerning Bone and Muscle Health of Aged Individuals

This study focuses on researching sarcopenia and bone loss (osteoporosis), aiming to develop early and effective methods for diagnosis and treatment. These health issues significantly contribute to falls, fractures, and loss of independence and quality of life in old age, particularly affecting individuals impairments. To address these challenges, the study employs innovative imaging techniques based on artificial intelligence (AI) to accurately assess age-related muscle atrophy. A central approach is to analyze existing computed tomography (CT) images of older adults, using retrospective data to evaluate muscle quality. This method aims to efficiently assess muscle quality without additional resources. AI algorithms analyze fine details of muscle tissue, such as muscle adiposity and density. The algorithm can detect fat content within muscles, which negatively impacts muscle health and functionality, and identify irregularities or abnormalities in muscle fibers. This non-invasive approach is crucial for early detection of muscle atrophy and monitoring treatment success. Integrating AI technologies advances beyond conventional imaging techniques, allowing precise analysis of muscle quality. This method not only offers efficient diagnosis and monitoring of sarcopenia but also opens new avenues for personalized therapeutic approaches and improved patient care. Almost every elderly person has at least one existing CT scan, a common and excellent method of medical imaging for significant health issues. These images can be retrospectively analyzed for muscle health. In addition to imaging techniques, the study includes functional tests such as hand strength and walking speed measurements to assess muscle health and condition. These tests establish objective quality characteristics of muscles and assess the effectiveness of prevention and treatment measures. This research aims to provide early diagnosis and effective treatment strategies for sarcopenia and osteoporosis, ultimately improving the quality of life for the elderly. By leveraging AI and existing medical imaging data, the study promotes efficient, sustainable, and precise healthcare solutions for age-related muscle and bone deterioration.

Galactooligosaccharide and Aging

Sarcopenia is a progressive muscle disease, most commonly affecting older individuals, that is categorised by 1) low muscle strength, 2) low muscle quantity or quality, and 3) low physical performance. This disease has several negative implications for human health, including an increased risk of falls, fractures, mobility limitations, and mortality. Sarcopenia also imposes significant burden on healthcare systems. For example, it was estimated that a 10% reduction in the prevalence of sarcopenia would save the US healthcare system $1.1 billion per year. Strategies to reduce the incidence and severity of sarcopenia are therefore of great interest. One potential cause for sarcopenia is long-term, low-level inflammation, which can occur for a number of reasons. One cause may relate to the intestinal wall becoming more susceptible to leaking of toxic particles. Evidence suggests that prebiotic supplementation can reduce this 'leakage'. Galactooligosaccharide (a prebiotic) has previously been shown to reduce inflammation in elderly individuals. The investigators hypothesise that galactooligosaccharide will improve physical function in the elderly indirectly via a reduction in inflammation. This will be a randomised, placebo-controlled, double-blind, parallel study. 32 elderly individuals (65-85 years; mix of males and females) will be randomised to one of two groups, GOS or PLACEBO. The GOS group will supplement their diet with 2.9 g galactooligosaccharide per day for 16 weeks in the form of one sachet (3.65 g) of Bimuno® Daily. The PLACEBO group will supplement with 3.65 g maltodextrin per day for 16 weeks. The study will involve one screening visit and two main trials (baseline and 16 weeks). For the main trials, participants will complete the short physical performance battery (SPPB) and handgrip strength test. In addition, participants will provide blood, urine and faecal samples, as well as a dual-energy x-ray absorptiometry (DEXA), and a peripheral quantitative computed tomography (pQCT) scan.

YOOMI: Effect of Gamified Physical Therapy Exercise Software on Inpatient Mobility

Patients admitted to the hospital often develop functional impairments due to being in bed most of the day. Each day of bedrest leads to significant muscle loss. As a result, many patients become dependent on others or require rehabilitation at a facility to improve mobility and function prior to returning home. Staff in the hospital is limited and often unable to mobilize patients every day while hospitalized. The investigators are testing a new experimental gamified physical therapy exercise software to see if it can be a fun, enjoyable way to help mobilize patients without the assistance of staff. The primary aim of this pilot/proof of concept study is to determine whether gamified physical therapy software can help inpatients exercise within the safety of their own beds and preserve pre-hospitalization function.

PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS

The investigators have designed a 2-center, pilot feasibility, randomized controlled trial (PROXIMUS) to determine the feasibility and safety of a larger multi center, randomized open-label trial comparing high protein combined with individualized exercise vs. standard management during the acute phase of critical illness in children. The investigators aim to determine the impact of the intervention on preservation of muscle mass; and functional status at 1 month and 6 months after randomization.

Impact of Skeletal Muscle Quality and Loss on the Outcome of Liver Transplantation

CT imaging-based skeletal muscle assessment has been found to predict the outcomes of many diseases. Previous evidence revealed that pre-transplant muscle quality and post-transplant muscle loss were associated with transplant outcomes. However, there is no prospective study supporting the aforementioned conclusions. This study aims to prospectively include liver transplant patients from multiple transplant centers, collecting their pre-transplant CT images as well as post-transplant CT images at specific time points. The objective is to further explore and clarify the correlation between skeletal muscle assessment and the prognosis of liver transplant patients. The goal is to provide guidance for peri-transplant health monitoring and disease intervention for liver transplant patients.

Physical Activity as Intervention Against Age-related Loss of Muscle Mass and Function

A minimum of 450 healthy individuals (62-70 years old) will be recruited. Each individual will be randomized into one of three groups stratified according to gender (M/F), BMI (≤28/\>28), and 30 sec chair stand (≤11/\>11). The three groups are Heavy resistance training (n=150), moderate intensity training (n=150), and control (n=150, no training). Assessments will be performed at baseline, after 12 months of intervention. Furthermore, follow up will be performed after 2,4,7, and 10 years. The primary outcome is change in leg extensor power after the intervention and during follow up. The primary hypothesis is that by applying the intention-to-treat analysis, the moderate intensity training group will increase leg extensor power just as much as the heavy resistance training group. The two training groups will increase muscle power more than the control group.