Clinical Research Directory

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.

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.

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.

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.

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.

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.

ePlatform for Promoting Health in Schools

There are few public health and educational policies specifically aimed at promoting physical activity, healthy dietary habits, and reducing sedentary behaviour among adolescents from socially disadvantaged backgrounds. ePro-Schools will co-design, pilot and evaluate an evidence-based program, delivered via a modular eHealth platform, to promote physical activity and healthy eating, and reduce time in sedentary behaviours. A profound co-creation process involving adolescents, school staff, and policymakers-alongside the adaptation of previous interventions by consortium members-will support the program's development. The ePro-Schools platform will contain modules for adolescents and their parents, teachers and school administration. Although the platform will be implemented through schools, it will include content to be implemented outside the school setting. The intervention program will be evaluated through a randomised controlled trial conducted in six secondary schools in Central Catalonia that aims to include 1000 adolescents. Schools have been randomised (1:1) into an intervention and a waiting-list control group. The evaluation of the program includes effectiveness, cost-effectiveness and process evaluation. Physical activity, sedentary behaviour and eating habits are the primary effectiveness outcomes of the trial. Secondary outcomes include fitness, water consumption, quality of life, depressive symptoms, social isolation and sleep quality. Using implementation science methodology, ePro-Schools will co-design transferable evidence-based practices and methodologies and guidance for scaling up the platform with policymakers and stakeholders, as well as informing specialists, policymakers and the general public.

Cardiovascular Risk Reduction-Diet in Pregnancy - Follow up 20 Years After the "CARRDIP"-Trial

The "Cardiovascular Risk Reduction-Diet in Pregnancy" (CARRDIP) - is a randomised controlled trial with dietary intervention during pregnancy. The participants were enrolled in Norway 20 years ago and consisted of 269 pregnant, healthy mothers. The participants were randomised 1:1 to either intervention-diet or control. The intervention diet was build upon an anti-atherogenic principle and was a so called "Mediterranean diet". The participants were monitored during pregnancy, and mother and child participated in a follow-up study 1 year after birth. The current "CARRDIP20" trial is a follow-up of the same participants, both mother and offspring, 20 years after the original intervention to measure and analyse the cardiovascular health and compare the intervention group to the control group.

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.

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.

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.

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.