Clinical Research Directory

Vitamin and Mineral Absorption From Milk and PBMAs

Plant-based milk alternatives (PBMAs) are a popular alternative to cow's milk. The different types of PBMAs on the market shelf include almond, oat, soy, coconut, cashew, pea, hemp, and rice. Among these, PBMA made from almonds, oats and soy are the most popular in North America. Though PBMAs are designed to mimic cow's milk in terms of color, they often have a very different nutrition profile. In order to better substitute for cow's milk, PBMAs often have added vitamins and minerals, as well as added sugars and flavorings to improve flavor. This study will test how well certain nutrients (vitamin D, calcium, potassium, and magnesium) are absorbed by the body after intake of milk and PBMAs. Nutrient absorption will be measured using blood samples after short term intake (from 1 hours to 1 week) of almond, soy, and oat milk, and compare it to cow's milk. Participants in the study will avoid all fluid dairy products and vitamin-D supplemented foods for three weeks and then be asked to consume either almond, soy, oat, or cow's milk for one week. All participants will visit the Clinical Nutrition Research Center (CNRC) four times over the course of about one month. These visits include a screening and pre-study visit (1.5 hrs), a pick-up visit (30 min), one long study day visit (\~11 hours), and two shorter follow up study day visits (1 hr).

Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine

This study is designed to test the feasibility and preliminary efficacy of a continuous glucose monitor (CGM)-augmented food is medicine (FIM) intervention for adults with type 2 diabetes and nutrition or food insecurity. This study will learn if a FIM intervention ("intervention") that includes access to real-time CGM and nutrition counseling can increase engagement, improve glycemic management, and support healthy eating in this population, compared to the FIM intervention alone ("comparator"). At the study baseline, participants will be randomized to either the intervention or the comparator arm for 16 weeks. The intervention will occur during the first 12 weeks (phase 1: intervention phase) and will be compared to a standard FIM approach without CGM or counseling. Phase 2 (extension phase) will last 4 weeks and will consist of all participants in the intervention and comparator arm receiving both FIM and CGM for self-directed use. The study will also explore participant experiences through a series of semi-structured interviews with a subset of randomly selected participants to identify opportunities for scaling the intervention to a broader population.

Resting Energy Expenditure and Substrate Consumption in Cardiac Arrest Patients Under Target Temperature Management

This study is a single-center, prospective, observational study. According to the sample size formula, an estimated 40 cases should be collected, all of whom are from the emergency intensive care unit. After successful cardiopulmonary resuscitation, the enrolled patients will be transferred to the emergency intensive care unit for further standardized target temperature management (TTM). They will be divided into 33 ° C hypothermia group and 36 ° C hypothermia group according to the patient's core body temperature. The baseline data of the patients will be collected at the beginning. After admission to the hospital, they were fasted within 24 hours to reach the target temperature, and then 20kcal/kg/d parenteral nutrition will be given. At selected time points (T0: the initial time point before TTM; T1: the core temperature was reduced to 33 ° C or 36 ° C; T2-T4: 33 ° C or 36 ° C was maintained for 24h, 48h, 72h; T5: the end of rewarming; Tend: the last REE measurement before discharge or death) , various observation indicators will be collected, including resting energy expenditure (REE), glucose oxidation rate, fat oxidation rate, protein oxidation rate, and metabolism of three major nutrients Proportion. Neurological outcomes were followed up 28 days after onset according to the Cerebral Performance Categories (CPC) score.

Effects of UPF Warning Labels on Social Media Among Teens and Young Adults

This study aims to evaluate whether Ultra-Processed Food (UPF) warning labels on social media posts improve consumer understanding and influence purchase intentions among teens and young adults. Participants aged 13-29 in the United States will be recruited and randomized into two groups: a control group (no label) and an intervention group (UPF warning). Participants will view social media posts featuring UPFs with or without warning labels and respond to survey questions following each post.

Impact of Food as Medicine Glycemic Control at Two Large Academic Medical Centers

The primary purpose of this study is to determine if the implementation of a food as medicine program would improve clinical outcomes when integrated into routine care at two large academic hospitals. 1. Determine if the FRESH Program's methods of addressing food insecurity improves clinical outcomes, reduces emergency room visits, and reduces hospital admissions for patients with diabetes, cardiovascular disease, surgery, and/or recent COVID-19 hospital admission. 2. Determine the feasibility and scalability of the FRESH Program nutrition intervention within two separate health systems in order to inform future state and federal policies governing reimbursement for nutritional interventions that improve food insecurity.

Impact of Genetic Polymorphisms And DASH Diet On Weight Loss Progression In Climacteric Women With Metabolic Syndrome

Metabolic syndrome is a multifactorial inflammatory condition that is very prevalent in overweight women with type 2 diabetes. However, there seems to be great benefit in changing lifestyle and dietary patterns in the treatment of this condition. Currently, few studies have shown the effect of a Dietary Approach to Stop Hypertension (DASH) diet in postmenopausal women with metabolic syndrome and the influence of genetic polymorphisms of the fat mass and obesity-associated protein (FTO) and beta-2 adrenergic receptor (ADRB2) genes on inflammatory markers and improvement of laboratory indicators in these patients. This study aims to analyze the interaction of polymorphisms in the ADRB2 and FTO genes and the DASH diet on anthropometric indicators and laboratory tests in patients with metabolic syndrome in the city of Rio de Janeiro. For this purpose, laboratory tests and anthropometric data will be collected in a prospective study with women aged between 40 and 60 years.

cMIND AI Web Tool Usability Study (Hong Kong)

This study is testing a new web-based tool that uses artificial intelligence (AI) to help older adults in Hong Kong check how healthy their Cantonese-style meals are for brain health. The tool is based on the cMIND diet, a Chinese-adapted version of a known healthy eating pattern that may support memory and thinking skills. Participants will use the web app to take photos of their usual meals for at least 10 days over two weeks. The AI will automatically identify ingredients and give a score showing how well the meal follows the cMIND diet. The study will also ask participants to complete a short questionnaire and a brief interview to find out how easy and useful the tool is for older adults. The purpose of this small study is to see whether the AI tool is user-friendly and acceptable for older people. Results will help improve the tool for future use to support healthy ageing and brain health.

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.

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.

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.

Healthy School Recognized Campus: A Hybrid Type 2 Implementation-Effectiveness Trial

Healthy School Recognized Campus is a Texas A\&M AgriLife Extension initiative that supports the delivery of school-based physical activity and nutrition programs for diverse youth across Texas. The purpose of this study is to conduct a type 2 hybrid implementation-effectiveness, cluster dual randomized controlled trial (DRCT) to assess both Healthy School Recognized Campus (HSRC) and the mentoring program.

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.

Dietary Macronutrients and Gut Microbiota, Inflammation, and Metabolic Markers

Poniżej znajduje się bardziej płynna i mniej powtarzalna wersja tekstu: This 12-week randomized controlled trial will investigate the effects of dietary patterns with different macronutrient compositions on gut microbiota, intestinal inflammation, gene expression, and metabolic health in healthy adults. Participants will be randomly assigned to one of three dietary interventions: a ketogenic diet (KD), a vegetarian diet (VD), or a control diet (CD) reflecting their habitual mixed dietary pattern. Adherence to the assigned diet will be monitored through dietary records and regular nutritional counseling. The study will evaluate changes in gut microbiota composition, inflammatory biomarkers, transcriptomic profiles, and blood biochemical parameters associated with lipid and glucose metabolism. Blood and stool samples will be collected at predefined time points throughout the intervention, while participants in the KD group will additionally undergo ketone monitoring to assess dietary compliance. By comparing the ketogenic and vegetarian diets with a standard mixed diet, this study aims to determine their effects on gut health, metabolic function, and systemic inflammation, thereby providing evidence to inform dietary recommendations. Ta wersja eliminuje powtórzenia ("diet", "study", "monitor", "effects"), jest bardziej naturalna stylistycznie i odpowiada standardowi językowemu publikacji w czasopismach z zakresu żywienia i medycyny.

Taxation Online Experimental Supermarket

Scientific context The increase in the consumption of unhealthy food coupled with a suboptimal consumption of healthier options have increased the risk of non-communicable diseases (NCD) worldwide. Among other public policies to address the rise in NCD -such as front of pack labelling, regulation of food and beverages in schools, marketing regulations targeted to children- taxation has been recognized as a cost-effective strategy to reduce consumption of taxed products. Although subsidies have been used to reduce food insecurity, with the rise in NCD associated with unhealthy diets, studies have explored the feasibility of combining subsidies to incentivize the consumption healthy food with taxes on unhealthy options. The impact of prices on dietary behaviour of consumers has been demonstrated in experimental designs as well as in economic analysis of observational data on purchases. Although some experimental studies have been used to study the impact of taxation and subsidies among specific populations in France, none has evaluated the impact in the general population. Objective The aim of the study is to evaluate the impact of implementing taxes on unhealthy food and beverages and subsidies to healthy food, separately and combined, on the nutritional quality of purchases, overall and by income level, in an experimental online supermarket. Intervention description: The intervention includes taxation of lower nutritional quality products (identified using the front-of-pack nutrition label Nutri-Score - classes D and E) and/or subsidies for products of higher nutritional quality (identified as raw products or Nutri-Score A and B). Design The intervention will be a parallel arm randomized trial stratified by income against a control situation with no changes in prices and the presence of the Nutri-Score on-pack for all pre-packed products in all interventions (control, taxes and subsidies). Expected public health impact: This study will allow to investigate the potential synergistic effect on the nutritional quality of food choices of combining taxation and income-based subsidies in a context of social inequalities in rising non-communicable disease associated with poor diets. Following a proportional universalism perspective, income-based subsidies can mitigate the regressivity of taxation according to income. As no countries have implemented this combination of fiscal policies to improve diets, the results of this study will contribute to the scientific knowledge on the topic and will provide preliminary results to decision makers.

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.

Food Swaps to Improve the Healthfulness and Reduce the Carbon Footprint of Grocery Purchases

The study aims to determine whether viewing health or climate labels (or both) and receiving recommendations for healthier or more climate-friendly swaps (or both) in an online grocery store environment improves the healthfulness and reduces the carbon footprint of consumers' food and beverage purchases compared to shopping as usual without swap recommendations. The online store will record participants' food selections. Participants will also be asked to complete survey measures.

The Causal Role of Ketone Bodies in Obesity-associated Disease Prevention - Combining Genetic Epidemiology With a Randomised Trial to Infer Causality

Excess weight increases the risk of several diseases including cardiovascular disease, type 2 diabetes, kidney disease and various cancers. There is a need for preventative strategies for obesity-associated disease, especially for people in the overweight and moderately obese ranges where pharmacological intervention may not be suitable. Low-carbohydrate (ketogenic) diets are popular for weight control. Ketogenic diets increase circulating ketones, which can have favourable effects on cardiometabolic health markers. However, the ketogenic diet has a nutrient composition associated with harms (high-saturated fat/red meat, and low-fibre). The net effects of ketogenic diets on long-term health are unclear. Ketone supplements can increase circulating ketones and could provide benefits of ketosis without needing to adhere to a potentially harmful diet. Establishing causality between complex exposures (e.g., diet) and long-term outcomes (e.g., disease), is challenging. The MRC \& NIHR Review of Nutrition and Human Health Research (2017) highlighted an "overreliance (as opposed to reasonable reliance) on observational studies" as a key barrier to progression in the field of nutrition and health. Randomised controlled trials (RCTs) facilitate causal inference, but for long-term outcomes are expensive, time-consuming, and often suffer from waning adherence. Mendelian randomization (MR) can estimate causal effects subject to key assumptions. A challenge to these assumptions includes complex behavioural exposures (e.g., diet), which could be intercorrelated with causal factors. Our proposal will address these limitations with a novel combination of study designs to establish causal effects of ketosis (via diet and supplementation) on obesity-associated disease risk in humans. The investigators will combine a tightly controlled, short-term RCT, with MR to link short-term responses to long-term endpoints. The investigators will examine the circulating (blood) and tissue-specific (adipose) transcriptomic and proteomic responses in the fasted and postprandial state in response to our dietary interventions and translate these to MR by identifying single-nucleotide polymorphisms from genome wide association studies. This approach overcomes limitations of RCTs and MR, as adherence to diets will be confirmed with controlled feeding, and intermediate molecular traits as exposure for MR are less likely to be intercorrelated with causal traits.

Maternal Methyl-Nutrient Status and Infant Neurodevelopment Study

This prospective cohort study examines the relationship between maternal methyl-nutrient status during pregnancy and offspring neurodevelopment. It integrates maternal dietary, biomarker, genetic, and microbiome data and follows children up to 24 months.

Oat Flakes β-glucan on Glycemic Variability, Pancreatic Reserve, and Dyslipidemia Among Adolescents With Type 1 Diabetes

Chronic iron overload represents a significant morbidity in Transfusion dependent β-thalassemia (TDT) leading to various endocrine complications including diabetes. The GLP-1 receptor agonist (GLP-1RA) Dulaglutide has recently been approved for pediatric type 2 diabetes (T2D) treatment. Objectives: to assess the effect of Dulaglutide versus conventional insulin therapy on glycemic metrics, pancreatic reserve, dyslipidemia and ferritin among children and adolescents with TDT related diabetes.

Evaluation of 7-day vs 1-day Packaging of Small Quantity Lipid-based Nutrition Supplementation (SQ-LNS)

Small Quantity Lipid-based Nutrient Supplements (SQ-LNS), are fortified, lipid-based nutritional supplements that were specifically designed for children 6-24 months to prevent malnutrition. Recent research has shown reductions in mortality, severe wasting, severe stunting, iron deficiency anemia, and developmental delays. SQ-LNS is currently available in individual daily dose packets of 20g. Healthy children age 6-24 months receive 1 packet per day (1dp), and are typically given a 1- or 2- month supply at a time (30-60 packets). Recently, Nutriset Développement has developed a new packaging design for SQ-LNS that reduces the cost by over 15% overall, through production efficiency with 40% less packaging, and improved transportation efficiency by 20%. This new packaging is a 140g packet that will allow 20g to be dispensed daily for 7 days (7dp). The packaging has a chamber that will allow for accurate 10g dosing (either twice daily, or twice at once). Users of the packaging will also be able to close the spout to minimize risk of microbiological contamination. Edesia Nutrition is working with Nutriset to conduct field testing of this new packaging for SQ-LNS, and this mixed-methods study in North Shoa Zone, Amhara Region, Ethiopia, will help inform recommendations for the future use of the package. The study seeks to determine (1) the acceptability of integrating SQ-LNS distribution into the malnutrition program; (2) whether adherence to the 2 different package types differs, and if there are differences in usage; (3) and how the packages perform over time, their perceived safety and functionality, and how they are stored. Educational and communication tools will be developed and pre-tested as part of this study, and will become part of the final deliverable package to Edesia Nutrition, in addition to final recommendations on the product packaging, findings about how the packages are used, and behavior change and nutrition education strategies. The primary outcome of the quantitative evaluation will be adherence, calculated as the number of delivered doses of SQ-LNS divided by the number of expected doses per week (7). Adherence will be measured via weekly self-report via caregiver interview and counts of return of used and unused packages during weekly home visits. The percentage of children who receive a dose during structured observation periods will be calculated. Each adherence outcome will be analyzed separately.

Influence of Food Texture on Appetite Control, Gastric Emptying, and Energy Expenditure

The aim of the study is to investigate the effect of liquid versus semi-solid meals on the regulation of energy balance in healthy young adults.The main questions it aims to answer are: * Does a protein-rich liquid meal result in less satiety and therefore higher ad libitum energy intake at the next meal than an isocaloric oatmeal with the same macronutrient ratio? * Is the consumption of a protein-rich liquid meal as a beverage in addition to an ad libitum oatmeal less compensated within the meal and at the next meal and provides thus a higher ad libitum energy intake than an isovolumetric noncaloric soft drink in addition to an ad libitum oatmeal? Researchers will compare a protein-rich liquid meal to an isocaloric oatmeal with matched macronutrient composition to answer the first question. Researchers will compare a protein-rich liquid meal + oatmeal to a noncaloric softdrink (water with sucralose and flavoring) + oatmeal to answer the second question. Participants will: * spend 4 intervention days in a metabolic chamber (whole room indirect calorimeter) * consume pre-definied preloads for breakfast and ad libitum lunch meals on 4 intervention days

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.

Organic Diet in Pregnancy and Risk Markers of Health Effects (The OrgDiet Project)

The OrgDiet project is a two-armed (1:1), open, intention-to-treat randomized controlled trial. The aim is to examine effects of consumption of organic foods (intervention group) vs. conventional foods (control group) during pregnancy in both mother and child. About 100 participants will be included and the participants will be followed until the children are two years old. Both groups will also be recommended to eat according to the dietary guidelines of the Directory of Health in Norway.

Randomized, Double-blind Crossover Trial Comparing Low-GI Functional vs. Standard Wholegrain Carbohydrates on Glycolipid Metabolism and Vascular Stress Markers in Adults With Suboptimal Triglyceridemia

Low-glycemic index (GI) carbohydrates help prevent type 2 diabetes and cardiovascular disease by reducing postprandial glucose, insulin spikes, inflammation, and triglyceride synthesis. They improve weight, lipid profiles, and vascular health. Our study will compare functional low-GI vs. standard wholegrain carbs in a Mediterranean diet to assess their effect on the Triglycerides-Glucose Index, a marker of metabolic and cardiovascular risk, in subjects with suboptimal triglyceride levels.