Clinical Research Directory

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.

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.

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.

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.

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.

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.

The Association Between Core Temperature and Health

The goal of this clinical trial is to learn if cold water drinking could promote body composition and further extend healthy lifespan in Chinese older adults. The main questions it aims to answer are: 1. Does cold water drinking lower the body fat percentage? 2. Will cold water drinking positively extend lifespan in a long-term Researchers will compare cold water intervention group to a control group (drinking 37℃ water instead) to see if cold water drinking works to promote health and slow down ageing process. Participants will: 1. Drink 4℃ or 37℃ water 4 times (9a.m., 12p.m., 15p.m., 18p.m.) every day for 6 months. 2. Visit the institute and health checkup department for tests and checkup at baseline, the end of the 3rd month, and the end of 6th month.

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.

Body Composition and Exercise to Prevent Muscle Loss With GLP1 Agonist Treatment

The goal of this study is to learn if a smartwatch that measures activity level and body composition, combined with exercise reminders, can safely improve strength and muscle mass in people who recently started or are planning to start treatment with incretin therapy (liraglutide, semaglutide, tirzepatide or retatrutide), also known as glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications.

Can EmeraldLED Reshape Your Body With Continued Use?

Already using EmeraldLED? TheGreen Light Therapy study explores how continuing participants' 15-minute sessions, twice a week, may continue to support positive changes in body composition.

How Does Continued Use of Green Light Therapy Impact Outcomes?

Already using Green Light Therapy? Explore how continued use with twice-weekly 20-minute sessions may continue to support positive changes in body composition. Discover whether this non-invasive wellness approach gets better over time to help support energy, balance, and renewal.

Discover Better Body Composition With Green Light!

Investigation into Green Light Therapy study using EmeraldLED for 15-minute sessions, twice a week, to support positive changes in body composition.

Dietary Patterns, Inflammation, Zinc Status, and Body Composition in Multi-Ethnic Women of Reproductive Age in Jakarta

This study aims to determine the relationship between dietary patterns and hair zinc levels with body composition, tumor necrosis factor alpha (TNF-α), and blood pressure in women of reproductive age from different ethnic backgrounds in Jakarta, Indonesia (specifically Minangkabau, Sundanese, Javanese, Betawi, and Chinese). Participants are assessed once through dietary assessment, anthropometric measurements, and biological sample collection.

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 (one week prior 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 0 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)

Dietary Management of Gestational Diabetes

eMOM is a randomized, controlled trial to compare the effects of two different dietary interventions during pregnancy. The comparison is based on tissue glucose content (using continuous glucose monitoring system) in pregnant women and on neonate body composition. The recruited women (n=60) have been diagnosed with gestational diabetes mellitus, and are of Caucasian origin. Of the study diets, one is moderately carbohydrate restricted and the other one is high on plant-based protein with an emphasis on healthy Nordic foods. The study has two two-week study periods that are carried out on approximately gestational weeks 24-28 (period I) and 34-36 (period II). Continuous glucose monitoring and other measurements (accelerometer, 3-day food record, gut microbiota, serum lipids, metabolomics, epigenetics etc.) are done during these study periods. At the beginning of the study, before study period I, the participants are randomized to either one of the intervention diets. The first study period consists of a crossover phase in which the participants receive three days' worth of food according to one of the intervention diets (according to the randomization) after which there is a three-day wash-out period. After the wash-out period, the participants receive three days' worth of food according to the other diet. After the first study period, a nutritionist advises the lastly followed intervention diet to the participant and the diet is followed until delivery. To ensure the diet is followed, the participants gets at least three personal face-to-face counseling sessions, phone calls, mobile reminders, recipes and food items. After delivery, the infant's body composition, epigenetic markers of cord blood and placenta, gut microbiome and urine metabolomics are measured.

Effectiveness of a Modified Cost-Effective Dietary Plan in Promoting Weight Loss and Preservation of Lean Body Mass in Patients After Bariatric Surgery

This study will see if a low-cost dietary plan, based on the standard dietary guidelines of the American Society for Metabolic and Bariatric Surgery (ASMBS) and using locally available foods, can help patients lose weight and keep their lean body mass after bariatric surgery. It will also check if this plan can maintain healthy levels of important nutrients such as vitamin B12, iron, and vitamin D. Patients who have undergone bariatric surgery will be randomly assigned to follow either the low-cost diet or the regular hospital diet. Their weight, body composition, and nutrient levels will be tracked at baseline, and at 1, 3, and 6 months after surgery. The aim is to find out if this simpler, affordable diet, which follows international standards, works as well as the regular plan while being easier for low-income patients to follow.

Monitoring Nutritional Consequences of Obesity Treatment on Women's Health

The goal of this observational study is to investigate the long-term effect of obesity treatments on the health of women. This study will specifically focusses on the effects on nutritional intake, nutritional status, musculoskeletal health and reproductive health. Additionally, this study will also investigate the effect of obesity treatment on pregnancy outcomes and child development. To achieve the goal of this study, participants already receiving either surgical treatment for obesity or treatment with anti-obesity medication as part of their regular medical care will fill in additional questionnaires, provide blood, urine and feces samples, and undergo additional measurements of body composition and muscle strength up to for 10 years.

Validation of Artificial Intelligence-based Digital Anthropometry Applications for Estimating Body Composition.

Anthropometric measurements are commonly employed to evaluate body composition, morphology, and health-related parameters across diverse populations. While a cost-effective and field-friendly method, the COVID-19 pandemic has spurred research on digital anthropometry worldwide. Machine learning, a fusion of artificial intelligence and data mining, holds promise for enhancing data collection and analysis in Kinanthropometry applications. Rather than replacing traditional methods, digital anthropometry presents a significant opportunity to enhance accuracy, validity, practicality, and the implementation of self-monitoring procedures under professional guidance. The CyberMetron Project by DBSS aims to perform additional research and increase scientific literacy among practitioners for public awareness of digital anthropometry.