Clinical Research Directory

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.

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.

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.

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.

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.

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.

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.

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.

CHANGES IN SLEEP QUALITY AND BODY COMPOSITION FOLLOWING A MULTIMODAL LIFESTYLE INTERVENTION IN OLDER WOMEN

This single-arm pilot study evaluated changes in sleep quality, body composition, biochemical parameters, physical activity, and psychological well-being following a 12-week multimodal lifestyle intervention in overweight and obese women aged 60 years and older. The intervention included individualized nutrition counseling, regular psychological support, and encouragement to walk for at least 150 minutes per week. Participants were assessed at baseline and at the end of week 12. Sleep quality was evaluated using the Pittsburgh Sleep Quality Index. Secondary outcomes included anthropometric measurements, biochemical parameters, physical activity level, and psychological well-being.

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.

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.

Mentoring to be Active for Rural Appalachia Children

The innovative MPBA+F begins with peer-to-peer mentoring followed by structured parental/family support for long-term reinforcement of PA behaviors. Building and reinforcing skills, MPBA+F mitigates resource stressors and strengthens protective factors by providing culturally appropriate knowledge and skills to improve the sustainability of physical activity at home without the use of exercise equipment. By strengthening social support through peer and friendship networks and family-based support, MPBA+F responds to the unique needs of rural Appalachians in a culturally responsive way. This study targets physical activity among children with overweight, obesity, or extreme obesity because rural Appalachian communities identify sedentary activity as a key contributor to the high rates of obesity and diabetes risk among youth.

DXA Study of Precision and Reliability

The purpose of the study is to assess precision of the GE Lunar iDXA, Hologic Horizon W DXA scanner, and the Stratec peripheral quantitative computed tomography (pQCT) scanner. Aim 1: To assess standard deviation (SD) and coefficient of variation (CV) of testing bone mineral, bone geometry, and soft tissues in inanimate objects and adults. Tests on adults will be structured to assess: 1. Within- and between-day variability of testing 2. Within- and between-technician variability of testing 3. Variability due to positioning and post-scan processing 4. Variability due to different DXA scanning equipment Aim 2: To assess the least significant change (LSC) for testing bone mineral and soft tissues in adults. Aim 3: To assess strengths and limitations of DXA and pQCT testing, including sensitivity to movement, rate of re-rescanning, etc. which are crucial components for demonstrating feasibility in grant applications. Aim 4: To construct a database of DXA and pQCT test results and quality control procedures, showing our laboratory's quality control level.

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.

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.

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.

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.