Clinical Research Directory

Nutrition for Precision Health, Powered by the All of Us

The goal of this Nutrition for Precision Health (NPH) powered by All of Us research study is to develop Artificial Intelligence/Machine Learning (AI/ML) algorithms that predict individual responses to diet patterns using rich multimodal data streams collected across multiple domains (e.g., behavior, social, environmental, clinical and molecular biomarkers). NPH includes a large phenotyping cohort (Module 1, N=8000) and two separate follow-up groups drawn from a subset of Module 1participants. One group (Module 2, N=1200) receives three distinct diets in a 14-day crossover sequence, with at least a 14-day washout period between diets, while living in their own homes. A second group (Module 3, N=150) receives the same three diets under full-time supervision in a residential research setting. We will train and test AI/ML models to predict 0-4 hour postprandial response curves for glucose, insulin, triglycerides, and GLP-1, to the standardized diet-specific meal test (DSMT) collected after each of the three different diets delivered in Module 2. Each diet functions as a controlled stimulus to reveal biological features (such as individual variables, patterns, or clusters of measurements) that best predict a person's response. The Module 2 DSMT response curves are the primary outcomes (dependent variables) for AI/ML algorithms that predict individual responses to diet patterns. As a secondary objective, NPH will evaluate the validity and acceptability of technology-based dietary assessment tools. The Automated Self-Administered 24-hour recall (ASA24), Automatic Ingestion Monitor-2 (AIM-2), and the mobile food record (mFR) will be evaluated in Modules 2 and 3, and the ASA24 food record and the image-assisted ASA24 recall will be evaluated only in Module 3. Total energy intake, macronutrient and dietary fiber intake data are the main outcomes for validity testing compared against measures of actual intake. Acceptability will be determined from feedback surveys.

Impact of Protein Formulations on the Stimulation of Muscle Protein Synthesis

The overall objective of this study is to determine the effects of ingesting protein that slowly releases amino acids into the blood vs. a control product on how our muscles regulate the synthesis of new proteins, termed muscle protein synthesis (MPS), in healthy volunteers.

Canadian Critical Care Comparative Effectiveness Platform

The Canadian Critical Care Comparative Effectiveness Platform(e) d'Évaluation Clinique Comparée en soins Critiques (CEPEC) is an international multi-centered randomized adaptive platform clinical trial. CEPEC will evaluate supportive care interventions that are used routinely in intensive care units throughout the world.

Extended Release Protein Dosing

The overall goal of this study is to determine the minimum dose required to elicit measurable elevation of plasma essential amino acid levels 12 hours after consuming VitaKey's extended release protein technology. The results of this study will be used to set a dose for future protein clinical studies.

Obesity and Aging: Impacts of Nutritional Counseling and Physical Exercise on Telomeres and Senescence Parameters

The study will involve 80 elderly women, 40 eutrophic and 40 obese, divided into four groups, each with n=20. 1) Eutrophic Group (EG) undergoing only nutritional counseling (NC), 2) Eutrophic Group with NC and combined training (CT), 3) Obese Group (OG) undergoing only NC, and 4) Obese Group with NC and CT. The study will be divided into two main phases: an initial 9-week phase dedicated to NC, followed by a 20-week CT phase.

Nutritional Status of Patients After Hematopoietic Stem Cell Transplantation

The main objectives of this study were :(1) to comprehensively and systematically evaluate the nutritional status of patients after hematopoietic stem cell transplantation. (2) to explore the effect of nutritional factors on the prognosis of patients treated by hematopoietic stem cell transplantation.

Food Access, Value, and Optimization of Resources

The main goal of the study is to examine the potential benefits of an educational workshop designed to help and support caregivers of children in families that struggle to get enough healthy food. The main questions are: * Does the FAVORes workshop impact household food and nutrition security? * Does the workshop change caregivers' knowledge, beliefs, and skills related to healthy food access? Participants will: * Attend four weekly in-person sessions (in English or Spanish) * Complete short surveys * Be interviewed after the workshop is completed (optional)

Sleep Well Firefighters: An App-based Program to Improve Sleep, Cognition, and Behavioral Health in Firefighters

The purpose of this pilot study is to examine the feasibility and acceptability of an app-based sleep program designed to help firefighters improve their sleep.

CHIME: Comparing Health Interventions for Maternal Equity

The goal of this comparative effectiveness trial is to compare how three different approaches to overcome barriers to resources and provide nutrition and physical activity counseling improve maternal healthy weight in pregnancy and postpartum. The main question it aims to answer is which of the two multi-level, multi-component interventions has greater effectiveness in reducing maternal postpartum weight retention at 12-months postpartum. Hypothesis (primary): Both multi-level, multi-component interventions will have greater effectiveness reducing maternal postpartum weight retention at 12-months postpartum than the usual care group. Hypothesis (secondary): The community-based intervention will have greater effectiveness than the self-management intervention. Participants will be asked to participate in one of the study interventions from early pregnancy until 12 months postpartum and complete five research visits. General procedures include completion of: * Questionnaires * Dietary recalls * In-depth interviews * Anthropometric measurements * Collection of blood via finger stick or blood panel

Evaluating the Effects of Nutritional Interventions on Sleep, the Gut Microbiome, Cognition, and Stress.

This will be a double-blind, placebo-controlled, parallel-group trial. Participants who are poor sleepers will be randomised to receive one of two investigational supplements, or a placebo control supplement, over a 28-day period. At baseline and following 28 days of consumption, sleep quality, gut microbiome profiles, cognitive performance, and mood will be assessed. Sleep outcome measures will also be assessed throughout the supplementation period to monitor the time course of any observed changes. A final data set of at least 66 participants is expected.

Effects of Light Exposure for Postpartum Depression on Infant Development

About 11% of women develop depression and anxiety after giving birth. These symptoms can reduce a mother's quality of life and daily functioning and may negatively affect her child's growth and development. Blue light therapy, based on chronobiology principles, has shown promising results for treating postpartum depression. It is relatively low-cost and has no known side effects. However, it is still unclear whether treating mothers with blue light therapy improves their children's growth and development. This study will investigate whether infants of mothers treated with blue light therapy for postpartum depression show better growth and developmental outcomes during their first year of life. Mothers diagnosed with postpartum depression within the first six weeks after childbirth will be assigned to one of two light exposure groups: a therapeutic blue light group or a control light exposure group (from another research study NCT06246214). A third group will include mothers without postpartum depression, and a fourth with previous depression. Children will be followed until 12 months of age. At that time, researchers will assess their growth, nutrition, and developmental milestones. The main goal is to compare child growth and development across these groups using statistical analyses.

Delivering Food Resources & Kitchen Skills (FoRKS) to Adults With Food Insecurity and Hypertension

The goal of this clinical trial is to determine the impact of a home-delivered foods and kitchen skills program on health and nutrition in adults with high blood pressure and food insecurity. Researchers will compare Food Resources \& Kitchen Skills (FoRKS) and Enhanced Usual Care (EUC) to evaluate the effects on mean systolic blood pressure (SPB), HbA1c, food security and nutrition. Participants will complete 24-hr blood pressure monitoring, standard blood pressure measurements, weight, finger stick for A1c point-of-care testing, and questionnaires.

Impacts of Sugar Warnings on Weight Bias

This study aims to examine the effects of added sugar warning labels for sugar-sweetened beverages (SSBs) on explicit weight bias and body weight attributional judgements. Participants will be assigned to view either control labels or added sugar warning labels applied on SSBs in an experimental store. Participants will shop for beverages in the store and take a computer survey during four visits to the store, spaced approximately one week apart.

Characteristics of Performance in Collegiate Cheerleaders and Dancers

This study aims to investigate performance differences between collegiate cheerleaders and dancers classified as normal weight obese and those classified as normal weight lean. The study will assess differences in physical performance, lifestyle behaviors, muscle quality, and nutrition-related factors between groups. Performance testing, body composition assessment, and questionnaire-based measures will be used to characterize these relationships.

The PASTDUe Nutrition Ecosystem Project (PASTDUe)

This is a research study to determine if a particular method of providing nutrition improves the clinical outcomes of patients in the intensive care unit (ICU) who have undergone abdominal surgery and would require nutrition delivered via the bloodstream (called total parenteral nutrition or TPN). The nutrition method we are testing is a structured nutrition delivery plan that involves tube feeding, oral nutrition supplements, and the use of a device (called an indirect calorimeter or IC) to measure calorie needs. This study will also use two devices to measure fat and muscle mass to examine changes during hospitalization. Subjects will be followed throughout hospitalization where nutrition status and fat and muscle mass will be closely monitored. Study activities will begin within 72 hours of a patient's abdominal surgery. TPN (total parenteral nutrition, a method of feeding that bypasses the usual process of eating and digestion) will be started, a non-invasive method of assessing calorie needs (indirect calorimetry (IC)) will be started, a urine sample will be collected to help assist in protein needs, and fat/muscle mass will be measured using bioelectrical impedance analysis (BIA), and an ultrasound. This is a minimal risk study and all products/devices used are non-invasive and FDA-approved. Indirect calorimetry and urine sample collection will be conducted every 3 days during the stay in the Intensive Care Unit - ICU, then every 5 days until hospital discharge. BIA and muscle ultrasound will be conducted every 7 days during ICU stay, then every 14 days until hospital discharge.

Body Composition and Lifestyle Factors in ROTC

This study aims to investigates the relationships between body composition, sleep, diet, and physical fitness in ROTC cadets. Further, it aims to evaluate the accuracy of body composition screening methods and identify lifestyle factors linked to performance. Methods include body composition testing, surveys, accelerometry, and fitness score collection from cadets.

Effects of Sulforaphane Supplementation on Athletic Performance

Considering the promising effects observed and the scarce and incipient scientific background of SFN in sports, the present study aims to evaluate the effects of SFN supplementation on fatigue, EIMD and recovery in trained individuals. In particular, outcomes such as time to exhaustion (TTE), and perceptual questionnaires of muscle soreness, recovery, and fatigue will be assessed, aiming to explore the effectiveness of SFN.

Nourish Clinical Trial

The purpose of the research study is to learn more about the best ways to teach cooking and food skills to adults, and how cooking classes may help reduce one's stress and food waste, as well as improve their diet.

Lifestyle and Its Association With Maintaining Health

This study is part of the LIFEHEALTH project and will be carried out in five Mediterranean European Union countries: Croatia, Greece, Italy, Slovenia, and Spain. The aim of this study is to assess adults' lifestyle habits and how they relate to their physical and mental health. Respondents in each country will be invited to complete an online questionnaire. The survey will ask about consumption of the Mediterranean diet, physical activity, sleep habits, stress perception, mental health, social relationships, and overall health. Each country will include about 500 participants to ensure a representative sample of adults living in Mediterranean regions.The questionnaire will be translated into local languages and participation is voluntary. Multiple linear or logistic regresion wil be used to assess relation between variables. These analyses will help identify which factors are most strongly linked to health outcomes. The results of this study will help researchers describe current lifestyle patterns in the Mediterranean population. They will also examine how different lifestyle habits are linked to physical and mental health. The findings may support public health initiatives and help plan future research to improve health and well-being.

Effects of Preoperative Whey Protein and Exercise Support on Recovery After Total Hip Arthroplasty

Objective: The aim of this project is to evaluate the effects of preoperative whey protein supplementation and a physical exercise program on postoperative recovery outcomes in patients undergoing total hip arthroplasty (THA). Specifically, inflammatory markers (CRP), nutritional status (albumin), mobilization time, length of hospital stay, and physical and social functioning will be assessed. As one of the first randomized controlled trials in Turkey to focus on the preoperative period and to evaluate a combined nutrition and exercise intervention in elderly surgical patients, this study holds pioneering significance in both clinical and academic contexts. Methods: This study is designed as a randomized controlled trial. The intervention group will receive whey protein supplementation and a home-based exercise program for 14 days preoperatively, while the control group will receive standard preoperative care. Data collection will be performed preoperatively and on postoperative days 3 and 5, focusing on metabolic and functional parameters. Expected Outcomes: The findings of this study are expected to contribute to the improvement of patient care through a multidisciplinary approach, inform health policy development, and provide a foundation for larger-scale clinical research in Turkey.

Impact of Diet and Nutrition on Growth and Development in Young Children

The association between nutrition in early life and its long-term health consequences has long been known. However, there is a scarcity of scientific evidence on how nutritional status affects child growth and development in remote, rural agro-pastoral communities with distinct dietary intake habits, geographical location, socio-economic status, and cultures.

The Effect of PIOMI and Chronobiological Nutrition on Readiness for Feeding, Full Transition to Oral Feeding and Body Weight

This is a randomized controlled experimental study evaluating the effects of oral motor intervention and chronobiological approach to feeding model applied to preterm infants on feeding readiness, transition to total oral feeding and body weight.

Web-based Platform for Nutrition Management in Patients With Cancer

It is crucial to promptly identify nutritional issues in these patients within the community and provide them with dietary guidance, nutritional counseling, and support. This study will be conducted in communities in Chengdu, Sichuan. Community management teams will register oncology patients, collecting information such as demographic data, tumor type, stage, specific treatment plan, treatment hospital, regularity of hospital admissions, and frequency of independent smartphone use. Registered patients will be screened based on inclusion and exclusion criteria. For those who meet the criteria, the community management team will contact them and recommend the use of a dedicated app developed by the research team. An initial nutritional assessment will also be conducted. Patients identified with nutritional risks will be directly referred to the research team's clinical nutritionists for face-to-face consultations. After additional tests, such as body composition analysis, necessary nutritional education and stepwise nutritional interventions will be provided. These patients will also use the app for dietary monitoring and nutritional guidance. For patients without nutritional risks, the app will be recommended for daily questionnaire completion and activity tracking.

The Effect of Pharmacotherapy With GLP-1 and GIP/GLP-1 Analogs on Changes in Qualitative and Quantitative Parameters of the Diet as Well as Metabolic and Behavioral Parameters in Patients With Excess Body Weight

The aim of this study is to comprehensively assess the early and long-term effects of GLP-1 and GIP/GLP-1 analogue medications on metabolic and behavioral parameters, with particular emphasis on qualitative and quantitative dietary changes in patients undergoing treatment for overweight and obesity. Participation in the study will involve four follow-up visits per year at the Clinic of Diabetology and Internal Medicine, Central Clinical Hospital, University Clinical Clinical Hospital, Medical University of Warsaw: before treatment initiation and after 3, 6, and 12 months. The analysis will focus not only on metabolic effects (weight loss, changes in body composition, and improved biochemical parameters), but also on nutritional and behavioral aspects, including diet, appetite regulation, risk of malnutrition and muscle loss, and the occurrence of adverse events. The study will allow for a multifaceted assessment of the impact of treatment with GLP-1 and GIP/GLP-1 analogues on patients with excess body weight.