Clinical Research Directory

Feasibility of Lower-Body EMS Resistance Training in Postmenopausal Women

This pilot randomized controlled trial evaluates whether combining lower-body electrical muscle stimulation (EMS) with resistance training is feasible and beneficial for physically inactive postmenopausal women, who experience concurrent declines in muscle strength, body composition, arterial elasticity, and cardiac autonomic balance. Sixteen physically inactive postmenopausal women aged 50-70 years are randomly assigned (1:1) to either (A) supervised resistance training combined with lower-body EMS (applied to 6 muscle groups: lower back, lower abdomen, glutes, quadriceps, hamstrings, and calves) or (B) supervised resistance training alone. Both groups complete twelve 50-minute sessions (consisting of a 10-minute warm-up, 30-minute main exercise, and a 10-minute cool-down) over 6 weeks (twice weekly). Assessments before and after the intervention include body composition, lower-body muscle function, arterial stiffness, and 5-minute heart rate variability. The primary aim is to determine the feasibility of the protocol(recruitment, retention, session attendance, and intervention dose delivery) to inform a future definitive trial. Preliminary estimates of intervention effects on the measured outcomes are reported as secondary aims.

Evaluation of Molecular Hydrogen Supplementation to Enhance the Efficacy of Weight Loss Retreat in Overweight and Obese Adolescents

This randomized controlled trial evaluates whether molecular hydrogen supplementation enhances the effectiveness of a 4-week weight loss retreat in overweight and obese adolescents. Outcome measures include: body composition, physical status, blood samples (insulin sensitivity, lipid profiles, markers of oxidative stress and inflammation) and autonomic nervous system function.

Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty

Large for Gestational Age (LGA) infants have excess fat-mass (FM) proportion secondary to prolonged in utero exposure to an energy-rich environment. Our preliminary data suggest that excess FM proportion can be associated with oral feeding delay and a potentially modifiable therapeutic target to improve oral feeding outcomes. The objective of this study is to determine the impact of a short-term Fat-free mass (FFM)-indexed feeding on the oral intake volumes in LGA infants with oral feeding difficulties.

Effects of Lower Body EMS Training in Postmenopausal Women

This study evaluates the effects of a 8-week lower body Electrical Muscle Stimulation (EMS) training program on body composition, muscle function, and arteriosclerosis markers in postmenopausal women. Menopause is associated with a rapid decline in estrogen, which increases the risk of sarcopenia (muscle loss) and arterial stiffness (cardiovascular disease). While resistance training is effective for these conditions, participation rates among postmenopausal women are often low. This study investigates whether applying EMS during lower body resistance exercises provides superior benefits compared to resistance training alone or no intervention. Participants will be randomized into three groups: 1. Lower-body EMS combined with Resistance Training Group 2. Resistance Training Only Group 3. Control Group (No intervention) The study aims to verify the efficacy of EMS as a time-efficient and effective alternative exercise modality for improving vascular and musculoskeletal health in this population.

Comparison of Smartphone-Based 3D Body Measurements With Traditional Anthropometry and 4D Stereophotogrammetry

This study investigates the accuracy, validity and reliability of smartphone-based 3D body scanning applications compared with traditional anthropometric measurements and a 4D stereophotogrammetry system.

Body Composition and Adipose Tissue in HIV

In this study, the investigators will examine the effect of therapy with the Growth Hormone Releasing Hormone (GHRH) analog tesamorelin on body composition in patients with HIV lipodystrophy and central adiposity. This study is a single arm prospective study of tesamorelin therapy of patients with HIV lipodystrophy. Subjects will do body composition testing, adipose tissue biopsy, metabolic rate measurements and insulin sensitivity assessment before, 6 and 12 months after daily injections of tesamorelin 2 mg by subcutaneous injection.

Comparing High-Protein and Low-Protein Multi-Ingredient Supplements for Body Composition and Performance in Elite Rugby Players

The purpose of this 12-week study is to compare the effects of two different post-exercise nutritional supplements on the body composition and exercise performance of elite male university rugby players. Athletes often consume very high amounts of protein to build muscle and recover, but excessive protein intake might pose potential health risks. Study Hypothesis: The researchers hypothesize that a multi-ingredient supplement with a lower total protein content (about 20 grams) will yield comparable or even superior improvements in body composition and physical performance compared to a standard high-dose whey protein supplement (40 grams). Study Design: Twenty elite male college rugby players will be randomly divided into two equal groups. One group will receive the high-dose whey protein, while the other group will receive the lower-dose multi-ingredient supplement (which includes protein, leucine, creatine, red amaranth, and elderberry). Participants will consume their assigned supplement immediately after their training sessions, four times a week for 12 weeks. Assessments: Before and after the 12-week intervention, the researchers will measure the participants' body composition (muscle and fat mass), maximum muscle strength, power, agility, and aerobic endurance. The overall goal is to determine if athletes can achieve optimal performance and muscle growth with a lower, more efficient protein intake strategy.

Calisthenics-Based Intervention in Adolescents: Effects on Strength, Body Composition, Eating Habits, and Self-Concept

This study evaluates the effectiveness of a school-based calisthenics intervention in promoting physical activity and improving health-related outcomes in adolescents. Physical inactivity during adolescence is a growing public health concern associated with increased risks of obesity, poor physical fitness, and reduced psychological well-being. Schools provide an optimal environment to implement structured interventions that encourage lifelong healthy habits. Calisthenics is a form of exercise that uses bodyweight movements to improve strength, flexibility, and coordination. It is cost-effective, accessible, and does not require specialized equipment, making it particularly suitable for school settings. The present study integrates a structured calisthenics program into regular physical education classes. A total of 100 students aged 13 to 16 years will be randomly assigned to either an experimental group, which will participate in the calisthenics program, or a control group, which will follow the standard physical education curriculum. The intervention will last 12 weeks, with three sessions per week. Primary and secondary outcomes will be assessed at baseline and after the intervention. These include physical fitness (muscle strength), body composition, dietary habits, and self-concept. Strength will be measured using a handgrip dynamometer, body composition through anthropometric assessment, dietary habits through a validated questionnaire, and self-concept using the Self-Concept Form-5 (AF5). Findings from this study will provide evidence regarding the feasibility and effectiveness of implementing calisthenics in school settings as a strategy to improve both physical and psychological health in adolescents.

Mediterranean Diet Uptake and Nutrition on Child Health, Inflammation, and Early-life Symbiosis (MUNCHIES) Study

Toddlerhood (ages 2-3) is a critical window when the gut microbiome is still developing and eating habits are being established. Yet, many Canadian toddlers eat diets high in sugar and salt, which may affect long-term health. This study will test whether a MED diet can improve dietary inflammation, gut health, and body composition in toddlers and whether a tailored nutrition education program for parents can help families maintain healthy eating patterns. In this study, toddlers will be randomly assigned to a 3-week MED diet or their usual diet. Families in the MED diet group will receive free meal boxes for the 3 weeks, plus guidance from a nutrition researcher through a structured education program. The standard diet group will continue their regular diet with general nutrition advice. Researchers will collect dietary information, body composition assessments, and stool samples to measure gut microbiome composition and metabolites. This first study of a controlled diet intervention in toddlers, combining behavioral support, high-quality food provision, and advanced gut microbiome analysis, will help understand how early diet shapes lifelong eating habits and health, guiding public health strategies and precision nutrition approaches to prevent chronic disease from early life.

SUSTAINA Study: Effects of Sustainable Diet and Therapeutic Exercise on Health in Young Athletes

The SUSTAINA study aims to evaluate the effects of sustainable dietary programs combined with individualized therapeutic exercise on metabolic health, body composition, and musculoskeletal function in young athletes. Participants will be randomly assigned to different intervention groups receiving tailored exercise training and nutritional guidance based on Mediterranean diet principles. The study will assess physiological, anthropometric, and functional outcomes to identify effective strategies for preventing metabolic and musculoskeletal disorders.

Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents

Childhood and adolescence are crucial periods for prevention of obesity, as obese children are five times more likely to be obese at adulthood than lean children. To this purpose, sugar consumption should be reduced. The sugar alcohol erythritol is increasingly popular as sugar substitute in the food industry and is also recommended to diabetic patients. The substance is freely available. Recent acute studies show that erythritol has a positive influence on satiation and gastric emptying without affecting insulin and plasma glucose. In this trial, the investigators aim to assess the effect of a chronic intake of erythritol versus sucrose on insulin resistance in healthy adolescents. EryClot-Pilot: Erythritol is also produced by the human body and possibly elevated erythritol levels in the blood are an indication of an increased risk of cardiovascular disease, obesity or diabetes in the future. In a recently published study, a possible effect of erythritol on blood clotting function was described. In this in vitro experiment, increased blood clotting was observed when erythritol was added to clotting cells (platelets) in the test tube. Studies in humans on blood coagulation after administration of erythritol are missing so far. With a pilot study, the investigators study whether erythritol is detectable in the blood after administration of glucose and fructose. Furthermore, the erythritol level in the blood and a possible effect on the blood coagulation function after administration of erythritol will be investigated. These preliminary tests serve to clarify the data situation so that further studies can be based on them. The preliminary results of the EryClot\_Pilot study indicate that there appears to be no measurable effect of erythritol on thrombocyte aggregation. This implicates that there is a discrepancy between our results and the results reported in a recent published study. This is why we need to assess the effects of erythritol administration on more parameters of blood coagulation as well as in more subjects. Due to a study published in June 2024, there appears the need to investigate the effects of xylitol on blood clotting function as well. EryClot in vitro: In addition to the human EryClot study, we will conduct in vitro experiments (aggregometry assay after addition of erythritol or xylitol in human platelet rich plasma).

Effects of 8-Week CrossFit-Based Concurrent Training on Fitness, Body Composition, and Psychological Outcomes in Schoolchildren

This study examines the effects of an 8-week CrossFit-based concurrent training program in boys and girls aged 7 to 11 years, comparing an experimental group (n=15) with a control group (n=15). The aim is to assess changes in strength, cardiorespiratory fitness, body composition, and psychological variables such as anxiety, stress, and self-esteem, using field-based physical tests (CMJ, Course Navette, handgrip strength, etc.) and validated questionnaires. The study follows a randomized controlled trial design with pre- and post-intervention assessments. The experimental group will complete two weekly CrossFit sessions adapted for children, while the control group will maintain their usual routine without structured physical training. The hypothesis states that the intervention will significantly improve both physical performance and psychological well-being in the experimental group compared to the control group.

Effects of an Exercise and Diet Program on Biochemistry and Body Composition in Patients With CKD in G1 and G2 Stages

How Exercise, a Controlled Diet and Education Improve the Health of People with Early-Stage Renal Failure: A Study at Ciudad Guzmán Hospital

The Synergistic Effects of Menopause and HIV on Cardiovascular Disease Risk in Women

Menopause is associated with the acceleration of many comorbidities, including cardiovascular disease. Whether HIV and menopause together increase cardiovascular disease risk is a key knowledge gap. The goal of this observational study is to address this knowledge gap by looking at the role of menopause on cardiovascular disease risk factors such as insulin resistance, hypertension, hyperlipidemia, and carotid atherosclerosis using previously collected data. The investigators will look at underlying causes for cardiovascular diseases worsening in menopausal women with HIV by looking at the role of increased inflammation in the body and whether this is altered by weight. The investigators achieve this by enrolling participants who are willing to undergo a whole body MRI.

Dose-Response Impact of Geranylgeraniol (GG) Supplementation on Muscle Health

This study will evaluate the effects of daily geranylgeraniol (GG) supplementation on muscular strength, body composition, and aerobic capacity in healthy, physically active men and women. Approximately 60 participants aged 30-60 years will be enrolled in a randomized, double-blind, placebo-controlled, parallel-group trial lasting 8 weeks. Participants will be assigned to receive either placebo, 150 mg GG, or 300 mg GG daily. Outcome measures will be assessed at baseline, week 4, and week 8 and include maximal strength (1RM bench press and leg press), fat-free mass, muscular endurance, aerobic capacity (VO2peak), and circulating biomarkers related to metabolism and health.

Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Prediabetes

The goal of this clinical trial is to determine the effectiveness of using a freeze-dried wild blueberry powder on cardiometabolic health, cognitive function, and gut microbiota composition in adult women with prediabetes.

EMS Combined With Resistance Training in Weight Lifters

The purpose of this randomized controlled trial is to determine the effects of Electrical Muscle Stimulation (EMS) combined with resistance training on muscle mass, muscular strength, body composition, and power in trained weightlifters. Participants will be randomly allocated into two groups: one receiving resistance training alone and the other receiving EMS combined with resistance training. The intervention will be conducted for eight weeks, and outcome measures will be assessed at baseline, mid-intervention (4 weeks), and post-intervention (8 weeks). The findings of this study may provide evidence regarding the additional benefits of EMS when combined with conventional resistance training programs in enhancing muscular performance among trained athletes.

Longitudinal Body Composition Assessment in Breast Cancer Patients

This observational cohort study aims to track longitudinal changes in body composition, including skeletal muscle mass and fat distribution, in patients diagnosed with breast cancer. Following primary surgery and adjuvant therapy, participants will be monitored over a 2-year period. The primary objective is to evaluate the natural progression of skeletal muscle mass index (SMI) and metabolic changes in this population. By conducting serial measurements, this study seeks to characterize the longitudinal trends in muscle loss and body composition shifts post-treatment, providing data to better understand the physiological impact of the cancer recovery process.

Body Composition and Lifestyles in Athletes With Disabilities

Disability involves limitations that affect mobility and the ability to perform daily activities and achieve competitive goals. It is expected that disability has a significant impact on body composition, including reductions in lean mass and bone mineral content, and increases in fat mass and its distribution. Additionally, the assessment of food and dietary supplement intake among athletes with disabilities remains poorly described, despite its relevance in both sports and health contexts due to the potential benefits of individualized nutritional strategies. This research project, entitled Anthropometric, Dietary, Exercise, and Supplementation Profile in Athletes with Disabilities (PADES), aims to describe the anthropometric characteristics, physical exercise practices, and food and supplement intake in Spanish athletes with disabilities. The study seeks to address the current lack of standardized anthropometric data and the limited information on dietary and supplementation patterns in this population, which hinders a comprehensive understanding of the physiological, nutritional, and biomechanical aspects essential for their health and athletic performance. A cross-sectional, descriptive-correlational study will be conducted in Spanish athletes with disabilities recruited through the Spanish Federation of Sports for People with Physical Disabilities (FEDDF), the Spanish Federation of Sports for the Blind (FEDC), and the Spanish Federation of Sports for the Deaf (FEDS).

Breastmilk and the Link to Overweight/Obesity and Maternal Diet in the Mother-breastmilk-child Triad

The prospective 5-month follow-up study will involve 150 mother-infant dyads grouped based on maternal baseline BMI category (normal weight, overweight, obesity). The investigators plan 3 study visits (1, 3, and 6 months postpartum) with analysis the following parameters and outcomes: 1. maternal anthropometry and body composition; 2. maternal dietary intake and dietary patterns (with results of biomarker-based validation); 3. maternal status of lipophilic antioxidants, selected vitamins, and fatty acids profile that may be related to adipose tissue metabolism, inflammation, and cardiometabolic status; 4. maternal metabolomics, adipokines, insulin, selected biomarkers of inflammation, altered glucose metabolism, and oxidation; 5. breastmilk composition assessed by systemic approach (macronutrients, fatty acids profile, lipophilic antioxidants, adipokines, hormones, immunological profile, and preliminary lipidomic analysis in part of the study group); 6. infant growth trajectory, body composition, urine metabolomics, and biomarkers of oxidative stress. Additionally, maternal and infant stool, buccal swabs, and human milk samples will be banked for further microbiome analysis studies.

Impact of Supplementation in Improving Metabolic Health Outcomes (ISMOS) Study

This study investigates the role of multivitamin and multimineral (MVM) supplementation in improving metabolic, musculoskeletal, and mental health among midlife Asian women aged 40-60 years, a critical period marked by hormonal and physiological transitions from pre- to post-menopause. Evidence from the GUSTO cohort in Singapore has shown that higher plasma levels of vitamins B6, B9, B12, and D are associated with better metabolic profiles, insulin sensitivity, and mental wellbeing, while deficiencies are linked to increased metabolic and psychological risks. Given that vitamin insufficiency and central obesity are highly prevalent among Asian women even at lower BMI, this randomized, double-blind, placebo-controlled trial will evaluate whether 12 months of daily MVM supplementation can reduce MetaboAge and improve metabolic, mental, and muscle health outcomes compared with placebo. Findings will inform preventive strategies for extending health span and mitigating chronic disease risks among midlife women in Asia.

CT Body Composition as Predictor of Exercise Therapy Outcome in Peripheral Arterial Disease

Supervised exercise therapy (SET) is the recommended first treatment for patients with leg artery disease (peripheral arterial disease, PAD) causing pain when walking. However, approximately 40% of patients do not benefit meaningfully and go on to require a procedure to open the blocked arteries within three months. This study investigates whether body composition measurements - specifically the quality of muscle and the amount of belly fat - taken from a CT scan already performed as part of routine care, can identify before treatment begins which patients are unlikely to respond to exercise therapy. If confirmed, this approach would allow doctors to use information from a scan patients are already having, with no additional tests, to better match patients to the right treatment from the start.

GLP-1RA Effects on Lean Mass and Bone Health in Midlife Women

This study is designed with the interest to learn on the effects of estrogen levels and how it affects body compositions and muscle function in midlife women who are taking a GLP-1RA for weight loss.

Open Space and Closed Years

The primary objective of this project is to examine the effects of a specific multicomponent physical activity program (MPAP), conducted in an outdoor setting, on the health and functional-motor status (HFMS) of women over the age of 60. Additionally, the study will investigate the influence of sociodemographic factors (SDF), physical literacy (PL), and health literacy (HL) on the baseline HFMS and the subsequent changes resulting from the KTP. Study Methodology The program participants will consist of older women (\>60 years; n=60) whose current HFMS allows for participation in the exercise protocol. They will be divided into two groups: Experimental Group: Will participate in the MPAP. Control Group: Will not participate in the MPAP. The exercise intervention (MPAP) will include a combination of aerobic activities, strength exercises, balance, and flexibility. It will be conducted two to three times per week across two three-month cycles, separated by a three-month break. Data Collection and Environment Assessments: Sociodemographic factors, physical literacy, and health literacy will be measured at the start of the study. A series of HFMS indicators will be recorded before and after each exercise cycle. Setting: The MPAP will be performed outdoors in a public park. Project Significance Beyond analyzing the direct effects of the exercise program and the correlations between the measured variables, this project will contribute to a deeper understanding of the importance of the natural environment in implementing goal-oriented physical activity for the elderly population.