Clinical Research Directory

Effect of HMB Supplementation and Vivifrail Exercise on Body Composition, Handgrip Strength and Physical Performance in Women Over 60 Years of Age

The goal of this clinical trial is to learn whether taking a daily supplement of β-hydroxy-β-methylbutyrate (HMB) while following a structured exercise program improves body composition, muscle strength and physical performance in older women. The main question it aims to answer is: does HMB (3 g per day) combined with the Vivifrail multicomponent exercise program improve handgrip strength more than the same exercise program combined with maltodextrin without HMB? Researchers will also compare body composition and physical performance between groups. Participants will take the assigned supplement every day for 12 weeks, attend three supervised Vivifrail exercise sessions per week at the Casa Club de la Tercera Edad (DIF Tulancingo, Hidalgo, Mexico), and complete evaluations at baseline, week 6 and week 12.

Effects of the 11 for Health Program on Physical Fitness and Health-Related Outcomes in Schoolchildren

This study aims to examine the effects of the 11 for Health program on physical fitness and health-related outcomes in fifth-grade students. The study will use a quasi-experimental pretest-posttest design with a control group. Approximately 70 students from two fifth-grade classes at a public school in Türkiye will participate. One class will participate in the 11 for Health program. The other class will be the control group. The intervention group will participate in the program twice a week for 11 weeks, with each session lasting 45 minutes. The program combines football-based physical activities with health education. The control group will not receive the program. Students in both groups will undergo physical fitness and health assessments before and after the intervention. These assessments will include jumping performance, balance, change-of-direction performance, flexibility, body fat percentage, blood pressure, and resting heart rate. Researchers will compare changes in these measures between the two groups to evaluate the effects of the program.

Psychological, Hormonal, and Physical Performance Profiles in Adolescent Male Football Players: An Exploratory Cross-Sectional Study

This study aimed to examine the relationships among psychological characteristics, hormonal markers, body composition, and physical performance in adolescent male football players. Twenty-one male football players participated in this cross-sectional correlational study. Assessments included anthropometric measurements, jumping, sprinting, agility, kick speed, psychological well-being in sport, and mental toughness. Blood samples were collected to measure testosterone, FT3, and FT4 levels. Data were examined using partial correlation network analysis, centrality analysis, hierarchical clustering, and principal component analysis.

Creatine and Muscle Health in Madrid's Walking Footballers.

Healthy aging requires effective, accessible, and sustainable interventions capable of preserving functional capacity and preventing age-related decline. In this context, walking football has emerged as a safe, inclusive physical exercise modality with high adherence among older adults, demonstrating benefits for muscle health, metabolic profile, and psychosocial well-being. On the other hand, creatine monohydrate supplementation is backed by robust scientific evidence as a strategy to enhance exercise adaptations, promote muscle mass maintenance, and improve factors related to metabolic syndrome. The objective of this project is to evaluate the effects of creatine supplementation combined with regular walking football practice on muscle quality and metabolic profile in older adults, as well as to explore the underlying biological mechanisms using a cell culture-based experimental model. The ultimate goal is to determine the potential of this intervention to promote healthy longevity through functional, muscular, and metabolic indicators associated with healthspan. Specifically, the study will analyze the intervention's effects on body composition, physical fitness, and metabolic syndrome markers; evaluate its impact on psychosocial well-being, quality of life, and cognitive function; and investigate the molecular mechanisms related to muscle health, protection against oxidative stress, and the modulation of senescence using an ex vivo/in vitro model. The project will be carried out in two complementary phases. First, a longitudinal experimental study will be conducted in older adults participating in walking football programs and supplemented with creatine. Subsequently, skeletal muscle cultures will be exposed to conditioned sera obtained before and after the intervention to investigate its biological effects. This approach will integrate the evaluation of clinical efficacy with the study of the underlying mechanisms, generating applicable knowledge for designing personalized, sustainable, and cost-effective strategies to prevent sarcopenia and metabolic syndrome.

Resting Metabolic Rate in Bodybuilders Using Performance-Enhancing Drugs

Bodybuilders present unique body composition profiles, characterized by high fat-free mass and very low levels of body fat. In addition, many competitive and non-competitive athletes use anabolic-androgenic steroids (AAS) and fat-burning pharmacological agents to enhance muscle mass and accelerate fat loss. Accurate determination of energy requirements is critical for performance and nutritional planning in this population. Resting metabolic rate (RMR) represents the largest component of daily energy expenditure. While indirect calorimetry is considered the reference method to assess RMR, it is expensive and not widely accessible, making predictive mathematical equations the primary tool used in sports and clinical settings. However, widely used equations (such as Harris-Benedict, Mifflin-St Jeor, and Cunningham) were developed in general or non-athletic populations and may systematically underestimate energy requirements in bodybuilders using performance-enhancing substances. The primary aim of this cross-sectional study is to measure resting metabolic rate via indirect calorimetry and body composition via dual-energy X-ray absorptiometry (DXA) in adult bodybuilders using anabolic and fat-burning agents. The ultimate goal is to develop and validate a population-specific predictive equation for RMR and compare its accuracy against established predictive formulas.

Effects of Daily Kefir Consumption During Medical Nutrition Therapy on Body Composition and Psychological Well-Being in Women With Obesity

This randomized controlled study evaluated the effects of daily kefir consumption as an adjunct to medical nutrition therapy on body composition, biochemical parameters, gastrointestinal symptoms, bowel habits, and psychological well-being in women with obesity. Participants were randomly assigned to receive either 200 mL of plain kefir daily together with individualized medical nutrition therapy or individualized medical nutrition therapy alone for 12 weeks. Assessments were performed at baseline, week 6, and week 12. The primary outcome was change in body weight. Secondary outcomes included changes in body composition, biochemical parameters, gastrointestinal symptoms, bowel habits, and psychological well-being.

Long-Term Effects of Semaglutide on Body Composition and Performance in Running

Semaglutide, a GLP-1 receptor agonist, has demonstrated significant weight-loss effects in people with obesity and/or type 2 diabetes, but its impact on exercise performance among lean, fit athletes remains unknown. This randomized placebo-controlled parallel intervention study aims to investigate the long-term effects of semaglutide on body composition, muscle mass, volume and function, running economy, and performance as well as on hormonal markers in well-trained male and female runners.

Short Term Effects of Semaglutide on Body Composition and Performance

Semaglutide, a GLP-1 receptor agonist, has demonstrated significant weight-loss effects in people with obesity and/or type 2 diabetes, but its impact on exercise performance among lean, fit athletes remains unknown. This randomized placebo-controlled parallel intervention study aims to investigate the short-term effects of semaglutide on body composition, muscle mass, volume and function, running economy, and performance in well-trained male and female runners.

Lifestyle Intervention to Improve Muscle Function in Older Adults

The goal of this randomized controlled two-arm trial is to determine the effect of a diet and exercise intervention for 12 weeks on body composition, muscle function, and energy balance in 80 adults aged 50 years and over with obesity and insulin resistance. The main questions the trial aims to answer are: Will 12 weeks of a structured nutrition plan + exercise reduce fat mass, improve muscle function, and increase energy deficit compared to the usual diet + exercise. The hypothesis is that 12 weeks of a structured nutrition plan + exercise will reduce fat mass, improve muscle function, and produce greater energy deficit than the usual diet + exercise. Participants will be provided with all meals for 12 weeks and will exercise at the Center under supervision three times each week. Pre and post-intervention, body composition, physical function, and energy deficit will be measured.

Physiological and Performance Characteristics of HYROX Athletes

HYROX© is a fast-growing fitness competition that combines long-distance running with functional exercises such as sled pushes, rowing, and weightlifting movements. Although the sport has attracted more than a million participants worldwide, little scientific research has looked at the health, body composition, and physical fitness of the people who compete in it. This study will compare body composition, fitness, and performance between two groups of HYROX© participants: those competing at a recreational (amateur) level and those competing at an elite level. Adult volunteers (ages 18-65) who train for or compete in HYROX© will be invited to take part. Researchers will measure body composition using a whole-body scan (DXA), skinfold thickness, and muscle ultrasound; resting metabolism; daily physical activity (using a wearable activity tracker); muscle strength and jumping ability; aerobic fitness (a treadmill running test); and short-burst power (a cycling test). Participants will also complete questionnaires about their motivation to exercise, their diet, and their use of dietary supplements, and will wear a heart rate monitor and activity tracker during an official HYROX© competition. The results will help researchers, coaches, and athletes better understand how the bodies and training needs of HYROX© athletes differ by competitive level, which may support the development of safer and more effective training programs.

Micronutrient Enhancement for Development and Health in Adolescents - The MEDHA Study

MEDHA is a randomized controlled trial among 10-18 year old girls to examine the use-case of the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) multiple micronutrient supplement (MMS) formulation and to test an enhanced regimen (MMS+) with additional nutrients, vs. weekly iron-folic acid as standard of care on outcomes of neurodevelopment, linear growth, biochemical status, bone health, and other functional and health outcomes. This study is an individually randomized, open-label, three-arm trial of 3,000 participants supplemented for 12 months to assess the efficacy and safety of nutrient supplementation. Results of the study will inform the design of nutritional interventions and policy for this age group. In the context of the trial, the investigators will also do in-depth clinical and health assessments and collect biospecimens for a bio-archive for future deep-phenotyping of this population. This study will be conducted at the Johns Hopkins Bangladesh JiVitA field site in rural Gaibandha District of Bangladesh.

Feasibility and Potential Efficacy of Herbs and Spices for Improving Dietary Quality in College Students: A Pilot Study

The goal of this single-arm feasibility, pilot study is to assess the feasibility, acceptability, and potential effectiveness of the Herbs and Spices Nutrition Education Program (HSNP-focusing on incorporating herbs and spices into the diet for adherence to the DGA's) for determining the scalability of implementing this intervention for a larger scale, more comprehensive study The main questions it aims to answer are: * What is the feasibility and acceptability of incorporating herbs and spices into the diet along with DGA-focused nutrition education through the HSNP in college students with poor dietary quality? * What are the preliminary effects of the HSNP on dietary intake/quality, cardiometabolic, and gut health in college students with poor dietary quality? * What are the barriers associated with HSNP implementation in college students with poor dietary quality? Participants will: * Be asked to come to the study site initially for a Screening Study Visit to confirm eligibility. * Be asked to come the clinical study site for a Pre-HSNP and Post-HSNP Study Visit (within two weeks prior to starting the HSNP and after week 6 of completing the HSNP) for assessments of cardiometabolic and gut health. * Be asked to come to the Nutrition Center for weeks 1 and 3 of the HSNP, where they will receive education on the Dietary Guidelines for Americans and the health benefits of herbs and spices, have a sensory evaluation of foods, be provided budget-friendly recipes and resources, and given take-home herbs, spices, and supporting materials * Be asked to complete 3-Day Food Records throughout the 6 week study period for assessment of dietary quality (4 total)

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.

Four-Week Multicomponent Exercise Program in Older Adults

This study evaluated the effects of a four-week supervised multicomponent exercise program on physical function and body composition in older adults. Participants were allocated non-randomly to an intervention group or a control group based on their ability to attend the scheduled training sessions. The intervention group completed eight supervised 30-minute exercise sessions over four weeks, while the control group maintained their usual daily activity and did not begin a new exercise program. Physical function, muscle strength, gait, static balance, body mass, and body composition were assessed at baseline and after four weeks.

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

This trial is divided into different parts: Part A the EryAdo trial and Part B the EryClot trial. Part A EryAdo Trial: 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. Part B EryClot Trial: In recently published studies, a prothrombotic effect of erythritol and xylitol was described. Therefore, within a pilot study the investigators examined whether erythritol is detectable in the blood after administration of erythritol and conventional sweeteners (glucose and fructose). Also the effect on blood clotting was investigated. These preliminary tests served to clarify the data situation so that further studies can be based on them. The preliminary results of the pilot study indicated that there appears to be no measurable effect of erythritol on thrombocyte aggregation. This implicated 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 in more detail (thrombocyte aggregation, and markers of platelet activation, endothelial activation and coagulation) in more subjects. Due to a study published in 2024 describing similar prothrombotic effects for xylitol, this substance needs to be investigated as well. Thus, the participants will receive erythritol, xylitol, or water in a randomized order. In addition to the EryClot ex vivo experiments, we will conduct in vitro experiments incubating platelet-rich plasma from healthy donors with increasing concentrations erythritol or xylitol followed by measurement of platelet aggregation by aggreegometry assay.

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.

Maternal-Infant Exercise Program on Body Composition, Stress, Fatigue, and Attachment in Postpartum Women

The aim of this study is to explore the effectiveness of the intervention measures of the "Maternal-Infant Exercise Program" to improve the postpartum women's body composition, stress, fatigue and parent-child attachment.

Collagen Supplements and Post-MBS Muscle Mass/Body Image

This prospective, observational cohort study aims to evaluate whether the use of collagen-containing supplements is associated with differences in muscle mass, body composition, and body image among patients who have undergone sleeve gastrectomy (SG). The study will be conducted at the General Surgery outpatient clinic of a private hospital in Bursa, Türkiye, between May 2026 and March 2027, and will enroll adult patients (aged 18-65 years) who meet current ASMBS/IFSO eligibility criteria for metabolic and bariatric surgery. Participants will be naturally allocated into two observational groups based on their own choice to use or not use collagen-containing supplements; no supplement will be provided or recommended by the study team, and no intervention will be made to participants' standard clinical care. All patients will be followed according to routine clinical practice preoperatively and at 2 weeks, 1 month, 3 months, and 6 months postoperatively. Primary outcome measures include anthropometric parameters (body weight, BMI, fat mass, fat mass percentage, fat-free mass, muscle mass, percentage of weight loss, percentage of excess weight loss, waist and hip circumference) assessed via bioelectrical impedance analysis (Tanita MC-780 MA), and body image assessed using the Turkish-validated Body Shape Questionnaire (BSQ). Secondary outcomes include biochemical parameters, comorbidities, and macronutrient intake data obtained from 3-day dietary records analyzed using the BEBİS nutrition software. The study hypothesizes that patients using collagen-containing supplements will show significant differences in muscle mass and body composition parameters compared with non-users, and that supplement use will be significantly associated with BSQ scores. A sample size of approximately 52 participants per group was calculated using G\*Power 3.1 (one-way ANOVA, Cohen's f = 0.25, α = 0.05, power = 0.80).

Time Restricted Eating and Meal Frequency for Appetite Control

Obesity is one of the largest worldwide health problems. There are increasing rates of overweight and obesity, and in recent years, worldwide the percentage of overweight and obesity among adults now exceeds 1.9 billion and 650 million, respectively. Overweight and obesity are associated with an increase risk of type 2 diabetes (T2D), coronary heart disease, hypertension and other non-communicable diseases. There are multiple nutritional causes for obesity, including both the type and amount of food consumed. Other non-nutritional factors can be just as important to influence body mass, such as the number of meals eaten, which is termed meal frequency. The changing food environment influences calorie consumption, such as increased food variety, increased availability and food processing, a nocturnal lifestyle that disrupts the circadian clock, meal timing and frequency, irregular meal patterns, and prolonged duration of eating during the day. This results in increased food and beverage consumption throughout the day. Meal frequency is commonly defined as, 'the number of foods or drinks a person consumes in one day. Meals and snacks are less clearly defined. Meal is defined as any food providing≥ 50 kcal and separated by more than one hour. In most cultures, the name meal is given to the three eating episodes in a day: breakfast, lunch, and dinner; or breakfast, brunch, lunch, supper, and dinner. In this study, the investigators will use the definition of "breakfast, brunch, lunch, supper, and dinner", but it will be on restricted time: 10 hours eating and 14 hours fasting (from 7:00 to 17:00) and one type of diet (high protein diet). Other researchers have defined meals by the time of the day, such as early and late breakfast, lunch and dinner intake. These definitions differ according to culture. Other researchers have defined meals based on timing, such as (6:00 am -10:00 am), (12:00 pm - 3:00 pm), and (6:00 pm - 9:00 pm). Some studies have highlighted that there are factors that affect the number of meals which a person consumes. Eating a high amount of energy during breakfast helps to feel full for a longer period. Time of eating and duration of eating or not eating. The type of macronutrient intake; for example, high protein (HP) intake reduces ad libitum energy intake. The number of meals eaten per day; some studies have confirmed that consuming small frequent meals is better for healthy weight and appetite control in the general population, compared to consuming one huge meal a day. This can assist control of appetite and plasma glucose concentrations. On the other hand, recent research has indicated that consuming (≥6 meals/day) increases disease risk significantly more than consuming (1-2 meals/day). Some researchers believe that there is no relationship between meal frequency and body weight.

Aerobic, Strength, Kegel (ASK) Exercise Intervention Perceptions for Postpartum Health

The goal of this pilot clinical trial is to learn whether a 12-week home-based exercise programme is feasible, acceptable, and safe for postpartum women in Hong Kong who had hypertensive disorders of pregnancy. The exercise programme is called the Aerobic, Strength, and Kegel exercise programme, or ASK programme. The main questions this study aims to answer are: * Can postpartum women follow the ASK exercise programme at home? * Is the ASK exercise programme acceptable and safe? * Does the ASK exercise programme show early benefits for postpartum recovery and health? Researchers will compare women who receive the ASK exercise programme with women who receive standard postnatal care. Participants will be randomly assigned to one of the two groups. They will complete study assessments at the beginning of the study and after 12 weeks. Women in the ASK exercise programme group will complete three 60-minute exercise sessions per week for 12 weeks, supported by a mobile app and wearable device. Women in the standard postnatal care group will continue to receive usual postnatal care.

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.

Energy Expenditure and Body Composition of Infants and Young Children (6-24 Months Old) in Asia

This project is a collaboration between International Atomic Energy Agency (IAEA), FAO Regional Office for Asia and The Pacific, and Mahidol University, Thailand to carry out the study on doubly-labeled water for assessment of total energy expenditure and body composition among infants and young children aged 6-23 months old. Thailand conducted a longitudinal study with participation from 4 other countries, namely, Pakistan, Philippines, Sri Lanka and Vietnam, in undertaking the same assessments in a cross-sectional design.

A Clinical Trial to Evaluate the Effects of Cowboy Colostrum on Gut Health, Body Composition, Hair Growth, and Skin Appearance

This study evaluates the effects of Cowboy Colostrum bovine colostrum powder on gut health, body composition, hair growth, and skin appearance in generally healthy adults aged 21-47 with concerns in these areas. The trial is a single-arm, unblinded, virtual study conducted over 12 weeks in 35 participants who will use the test product daily. Participants will complete questionnaires and provide weight and waist circumference measurements at Baseline, Week 4, Week 8, and Week 12. The primary focus is on changes in weight and waist circumference, while secondary outcomes include participants' perceptions of gastrointestinal health, physical activity, hair growth, skin appearance, and overall health and well-being.

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.