Treatment Trials

288 Clinical Trials for Various Conditions

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COMPLETED
The Ready-to-Eat Meals for Cardiovascular Health Study
Description

The proposed project explores the acceptability and health benefits of ready-to-eat (RTE) meals based on the Dietary Approaches to Stop Hypertension (DASH) eating plan. The researchers have developed 14 recipes following the DASH eating plan, which is recommended for the prevention of cardiovascular disease (CVD). The prepackaged meals will be processed using Washington State University (WSU) microwave technologies to ensure food safety. In this pilot study, a sample of 30 participants will be recruited by to study the impact of the DASH meals on blood pressure. All meals will be provided to participants, who will consume the meals daily over a period of 4 weeks. Daily and weekly monitoring of participants (blood pressure and weight) will allow us to gain a scientific understanding on the preventive power of healthy diets in lowering blood pressure and reducing CVD risk.

COMPLETED
Validation of Plant-Based Vegan Meal for Gastric Emptying Testing in 10 Healthy Subjects
Description

The purpose of this research study is to compare the stomach emptying function using a current standard meal which includes eggs and our new vegan meal alternatives for patients who are not able to eat eggs.

ACTIVE_NOT_RECRUITING
A Phase 1, Open-Label, Randomized, Single-Dose Crossover Study to Evaluate the Potential Impact of High-fat Meal on the Pharmacokinetics of CRS3123 200 mg Capsule in Healthy Adult Participants
Description

This study will explore the potential effects of high-fat meal on the plasma pharmacokinetics (PK) of CRS3123 when administered as a single oral dose of 200 mg in healthy adult participants.

NOT_YET_RECRUITING
Giving Healthy Meal Kits and Cooking Lessons to Rural Families with Food Insecurity.
Description

The goal of this clinical trial is to learn if providing healthy meal kits to food insecure families can help lessen the social and emotional impacts of food insecurity on kids and their caregivers in rural Maine. The main questions it aims to answer are: 1. Is receiving healthy meal kits delivered to homes feasible and acceptable to rural Maine families? 2. Does receiving meal kits (along with an app to help learn how to cook the food) improve food insecurity and diet quality in rural Maine families? 3. Does receiving meal kits (along with an app to help learn how to cook the food) improve family function in rural Maine families? We will look at caregivers' stress, family conflict, household chaos, and child emotional-behavioral symptoms. Participants will: 1. Recieve and prepare a dietitian-designed meal kit with 10 meals per week for 4 weeks. 2. Receive free culinary medicine education via an app that they will continue to have access to after the study ends. 3. Complete a 1-1.5 hour virtual visit at the beginning of and end of the study.

NOT_YET_RECRUITING
Using Continuous Glucose Monitoring to Quantify the Effects of NOURISH's Culturally Modified Meals on Asian Americans With Type 2 Diabetes
Description

The investigators are hoping to determine whether tailoring the diet of someone with type 2 diabetes to their ethnic group while following American Diabetes Association guidelines can make a significant difference in their blood sugar controls. Participants will be required to wear a Continuous Glucose Monitor (CGM) for 1-month so that the investigators can compare blood sugar levels when participants are eating their routine diet vs. the culturally tailored diabetes diet.

NOT_YET_RECRUITING
Medically Tailored Meals for Kids
Description

The purpose of this project is to learn whether an intervention that provides households with home-delivered healthy, frozen meals tailored to illness related conditions for 12 weeks during a child's treatment for serious illness is feasible and acceptable to the child and parent mainly responsible for the child's care.

ACTIVE_NOT_RECRUITING
Soup Meal Satiety Study
Description

This study will investigate food ingredients that may provide fullness to healthy adults after a meal. The ingredients will be incorporated into a lunch meal, and measures of hunger and fullness will be evaluated for several hours after the meal. Study subjects must be able to travel to the USDA Nutrition Center in Beltsville Maryland at scheduled times during the study for meals and study measures.

COMPLETED
Climate Impact Label Design and Fast-Food Meal Selection
Description

The primary objective of this study is to test the relative effects of climate-impact menu label designs on the healthfulness of consumers' fast-food meal choices. Participants will complete a hypothetical online meal ordering task using a survey which emulates the online menu of a burger restaurant chain. Participants will be randomized for exposure to menus featuring one of five labeling conditions. Secondary objectives include examining total greenhouse gas emissions per meal order and, through a post-order survey, perception of labels between the conditions.

Conditions
RECRUITING
Occupational Therapy and Registered Dietitian Services to Reduce Fall Risk Among Home Delivered Meal Clients
Description

The purpose of this study is to determine which of the following four service models is most effective for reducing fall risk among home-delivered meal clients: (1) meals alone, (2) meals + registered dietitian services, (3) meals + occupational therapy services, (4) meals + registered dietitian + occupational therapy services.

ACTIVE_NOT_RECRUITING
Improving Participation in Universal School Meals (USM)
Description

The purpose of this study is to assess the impact of an implementation strategy on participation in Universal School Meals (USM).

RECRUITING
Using Simplified Meal Boluses Versus Carbohydrate Counting in Adolescents With Hybrid Closed Loop Systems
Description

The goal of this trial is to evaluate blood sugar control in patients with type 1 diabetes when using a simple meal bolus strategy (small, medium, large meals) compared to carbohydrate counting when on a hybrid closed loop system. The main question it aims to answer are: What is the blood sugar time in range when using simple meal boluses versus carbohydrate counting? Participants will: Use the simple meal bolus plan for 4 weeks. Do precise carbohydrate counting for 4 weeks. Provide their continuous glucose monitor and pump data Take surveys about the experience of meal bolusing during the study

Conditions
RECRUITING
A Plant-Based Whole-Foods Meal Delivery Service for Patients With Multiple Myeloma Undergoing Autologous Hematopoietic Cell Transplant
Description

This clinical trial evaluates the impact of a plant-based whole-foods delivery service on the microbiome in patients with multiple myeloma undergoing an autologous hematopoietic cell transplant. An autologous hematopoietic cell transplant is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Loss of microbial diversity within the intestinal tract has been associated with poor outcomes for patients receiving autologous stem cell transplantation. A plant-based whole meal delivery service may increase the intake of foods high in fiber and nutrients therefore improve microbial health during the peri-transplant period. In this pilot study, study investigators will explore the feasibility of this approach.

RECRUITING
Medically Tailored Meals for Cardiovascular Health Equity
Description

This randomized clinical trial (RCT) will investigate novel approaches to enhance effectiveness, engagement, reach, and cost-effectiveness of medically tailored meals (MTM) programs for promoting cardiovascular health equity, focusing on economically disadvantaged New York City neighborhoods with a disparate burden of multiple cardiometabolic diseases. The main questions the RCT aims to answer are: 1. Does enhancing MTM programs, with culturally relevant cardiovascular health curriculum (including educational sessions on heart health, healthy diet, cooking demonstrations, recipes, gift bags with healthy ingredients, and addressing social needs) enhance program engagement and effectiveness in improving short-term healthy eating behaviors and clinical outcomes (HbA1c and blood pressure) among individuals with type 2 diabetes and elevated blood pressure who currently qualify for MTM programs? 2. Is the MTM program coupled with the Cardiovascular Health (CVH) curriculum effective for improving healthy eating behaviors and clinical outcomes (HbA1c and blood pressure) among individuals with type 2 diabetes and elevated blood pressure who do not currently quality for MTM programs and is a gradual reduction of MTM dosing an effective and sustainable approach for expanding reach of these programs? To answer question 1, 100 participants with type 2 diabetes and elevated blood pressure who currently qualify for MTM programs will be randomized into a group that receives the standard MTM program (10 MTMs/week for 8 months) or a group that receives the standard program plus the cardiovascular health curriculum. To answer question 2, 100 participants with type 2 diabetes and elevated blood pressure who do not currently qualify for MTM programs will be randomized into a group that receives the standard MTM program (10 MTMs/week for 8 months) plus the cardiovascular health curriculum or a group that receives standard MTM program for the first 3 months followed by a gradual reduction in dosing of the MTMs by 50% over the remaining 5 months plus the CVH curriculum. All participants will have their HbA1c and blood pressure measured and complete questionnaires about their diet quality, health and lifestyle behaviors, and program engagement and implementation at baseline, 3 months, and 8 months. (Objectives)

RECRUITING
Inhaled Insulin vs Rapid-acting Injections for Post-meal Glucose Control in Women With Gestational Diabetes
Description

Pregnant women aged 18-40 with gestational diabetes (GDM) will take part in this study. We want to see how two different insulin treatments affect their blood sugar after they eat. These women usually use a rapid-acting insulin analog (RAA) that's injected to control their blood sugar before and after meals. They will come to the clinic for two meal sessions. For the first meal, we will randomly decide if they will use the usual RAA insulin or a newer inhaled insulin called technosphere insulin (TI). They will use the other type of insulin for their second meal. After each meal, we will compare their blood sugar levels.

COMPLETED
Effect of Acute Intake of Meals Containing Higher vs. Lower Energy From Protein on DIT
Description

The objective of this trial is to assess the effects of acute intake of mixed meals containing higher vs. lower energy from protein on diet induced thermogenesis (DIT) in adults with overweight or obesity.

RECRUITING
Effects of Common Meals on Appetite and Satiety
Description

The objectives of this study are to assess the impacts of meals composed of lean steak and potatoes (with a small portion of broccoli) in comparison to other common entrée/starch food combinations on metabolic and appetite responses.

Conditions
COMPLETED
Increasing School Meal Participation
Description

This study aims to determine whether an online marketing campaign increases children's school meal participation. Parents whose children do not currently eat school meals frequently will be exposed to messages designed to encourage their children's increased participation in school meals.

COMPLETED
Food and Friends: Healthy Meals Delivered to You
Description

The goal of this clinical trial is to learn if home delivered healthy meals (HDHM) with or without (intervention vs. control) social interaction can impact mental health and food security in adults aged 65 and older who live alone and have trouble accessing food. The main questions it aims to answer are: Does HDHM with or without social interaction change the quality of participant food intake? Does HDHM with or without social interaction change the loneliness that participants may experience? Does HDHM with or without social interaction change the depression that participants may experience? Researchers will compare a group that receives HDHM only to a group that receives HDHM and social interaction to see if there is a difference between the two groups in their experienced loneliness and depression, and the quality of food that they eat. Participants will receive 12 weeks' worth of HDHM delivered to their home. Half of the participants will receive weekly phone calls from volunteer student "companions) Participants will also be asked to complete questionnaires over the phone at three timepoints (baseline, 6 weeks, and 12 weeks) during the study. Some participants may also be asked to give their opinions on the program via a telephone conversation.

ENROLLING_BY_INVITATION
Evaluating an Enhanced Home-delivered Meal Program on Older Adults' Health and Well-being
Description

Meals on Wheels of Rhode Island (MOWRI), in partnership with the University of Connecticut (UConn), will implement and evaluate an enhanced version of its Home-Delivered Meals Program (HDMP). The project goal is to implement and test the effectiveness of an enhanced Home-Delivered Meals (HDM) service delivery approach. The enhanced approach includes community health worker (CHW) interactions and supplemental healthy grocery bags to address diet quality, food and nutrition security, loneliness, and health-related quality of life for older adults. MOWRI participants at the highest nutritional risk will be randomized to receive standard or enhanced services in order to test the effect of the intervention on health-related outcomes. Anticipated outcomes for individuals receiving enhanced services are improvements in measures of diet quality, food and nutrition security, loneliness, and health-related quality of life compared with those receiving standard HDM services.

RECRUITING
A Pilot and Feasibility Study to Evaluate High vs Low Glycemic Index Mixed Meal Tolerance Test in Adolescents and Young Adults With Cystic Fibrosis
Description

The goal of this study is to determine the extent to which excess dietary simple sugars serve as a secondary mediating factor in Cystic fibrosis-related diabetes (CFRD) development. The main questions it aims to answer are: * Whether conducting a randomized 2x2 factorial design that evaluates acute postprandial changes in glucose over 2 hours following ingestion of a mixed meal challenge that varies by glycemic index and consumption of a sugar-sweetened beverage is acceptable and feasible. * What are the preliminary changes in postprandial hyperglycemia, islet cell function, and incretin response to a high or low Glycemic Index mixed meal tolerance test (MMTT) with and without Sugar-Sweetened Beverages (SSB) in adolescents and young adults with CF Participants will be randomized to a mixed diet and blood will be drawn before and after the mixed meal challenge.

Conditions
RECRUITING
The Impact of a Plant-based Meat Meal Versus an Animal Meat Meal on Erectile Function in Healthy Men.
Description

The goal of this study is to determine whether erectile function is differentially impacted by a single plant-based meat meal versus a single animal meat meal in healthy men with normal erectile function.

RECRUITING
Meals 4 Moms: A Multilevel Community-based Lifestyle Intervention for GDM
Description

The goal of the project is to conduct a pilot feasibility randomized trial comparing a community-based lifestyle intervention called Meals for Moms (M4M) versus the usual care for pregnant persons diagnosed with gestational diabetes (GDM). Participants will be randomly placed into the usual care (UC) comparison group or the M4M healthy living program, which includes continued GDM education, physical activity level monitoring, and delivery of medically-tailored GDM meals. The trial will assess if M4M is feasible for the management of gestational diabetes in pregnant patients.

RECRUITING
Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose
Description

Background: Researchers use mixed meal tolerance tests (MMTTs) to look at how people s bodies respond to eating a meal. However, researchers do not agree on how to decide the number of calories to give in each meal. Some use fixed meals, which are the same size for everyone, and some use adjusted meals, based on the size of the person s body. Researchers want to know which MMTT is best to use for future research. Objective: To learn how fixed vs adjusted meals affect blood glucose levels in healthy people. Eligibility: Healthy people aged 18 years or older. Design: Participants will have 3 or 4 clinic visits of up to 8 hours in 8 weeks. Participants will have baseline tests: Their height, weight, and waist size will be measured. They will have an oral glucose tolerance test: A needle attached to a tube (IV) will be inserted into a vein in the arm. They will have a sugary drink. Blood samples will be taken from the tube at intervals up to 3 hours after the drink. They will have a body scan. Participants will have 2 MMTT visits. One will include a fixed meal and one will include an adjusted meal. They will have tests at both visits: Resting metabolic rate: A clear hood will be placed over the participant s head while they rest for 20 minutes. This will measure the oxygen they breathe in and out. MMTT. Participants will have 5 minutes to drink a liquid meal. Blood samples will be taken at intervals for the next 4 hours....

TERMINATED
Immediate Release Torsemide Versus Extended Release Torsemide After Salty Meal
Description

The goal of this randomized double-blind crossover study is to assess whether a morning dose of the extended release torsemide has a better efficacy than the ordinary immediate release torsemide to induce renal sodium excretion after a salty lunch in patients with stable heart failure. The main questions it aims to answer are: * Are the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a morning dose of extended release torsemide different from the amounts after the immediate release torsemide. * Are the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a salty lunch, which will be consumed approximately 6 hours following a morning dose of extended release torsemide, different from the amounts after the immediate release torsemide. * Is the amount of excreted sodium in the urine during the 24 hours' time period after a salty lunch, which will be consumed approximately 6 hours following a morning dose of extended release torsemide, different from the amount after the immediate release torsemide. Participants will be asked to: * Start taking daily immediate release or extended release torsemide tablets that is provided to them. * Eat the meals with standard contents of sodium that is provided to them and avoid other meals, drinks (except for water) and snacks for the duration of the study. * Collect urine for 24 hours, after approximately one week of the initiation of the study medication. * Go to the clinical research center the day that the 24-hour urine collection is finished and stay there throughout the day to receive standard meals and to have blood and urine samples collected. * Switch torsemide pills to the new one that will be dispensed to them at the clinical research center. If they were taking the immediate release torsemide during the first part, then they will be given the sustained release torsemide and vice versa. The study is double blind; therefore, the subjects, study coordinators, and investigators are unaware of whether each subject is on immediate release torsemide first or on extended release torsemide first. * Collect urine for an additional 12 hours after leaving the clinical research center to be sent to the clinical research center the next morning. * Continue to take the provided meals and to avoid other meals, drinks (except for water) and snacks. * Again, collect urine for 24 hours, after approximately one week, take that to the clinical research center when the 24-hour collection is completed and stay there throughout the day to receive standard meals and to have blood and urine samples collected. * Collect urine for an additional 12 hours to be sent to the clinical research center the next morning. Researchers will compare the amount of sodium excretion when each subject is taking immediate release torsemide versus the time that the same subject is taking extended release torsemide.

Conditions
RECRUITING
Hormonal Responses to a Mixed Meal in People With Cystic Fibrosis
Description

In this exploratory study, the hormonal responses to a mixed meal will be examined in people with cystic fibrosis. The aim of this study is to find correlates with impaired glucose tolerance that is associated with this population.

Conditions
COMPLETED
Comparative Effectiveness of 7 Versus 21 Home-delivered Medically Tailored Meals to Improve Malnutrition Risk in Malnourished Patients With Heart Failure
Description

This protocol is designed to compare the effectiveness of two dietary intervention doses for patients with heart failure (HF) and malnutrition risk or malnutrition at hospital discharge. This random order crossover design will provide evidence as to whether the provision of dinner meals alone versus all 3 daily meals to patients' homes is more effective at improving malnutrition risk score, and secondarily unplanned emergency department visits and readmissions.

COMPLETED
Tailoring OT and RD Services for Home-delivered Meal Clients
Description

This is a single-blinded, four-arm randomized controlled trial that will compare health outcomes of home-delivered meal clients. The purpose of this pilot study is to explore which service model is most effective for improving nutritional status, disease management, fall risk, and adherence to meal recommendations. Participants will be randomized into one of four study arms: In Arm 1: clients will receive home-delivered meals and basic nutrition education and fall prevention education. In Arm 2: clients will receive home-delivered meals plus dietitian services. In Arm 3: clients will receive home-delivered meals plus occupational therapy services. In Arm 4: clients will receive home-delivered meals plus dietitian and occupational therapy services. Outcomes will be assessed at baseline and at 3-month follow-up.

NOT_YET_RECRUITING
CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)
Description

The purpose of this multi-center clinical trial is to study the efficacy and safety of providing nutritional support added to the study-defined standard of care which consists of standardized dietary education and a single dietary counseling session shortly after discharge, versus study-defined standard of care alone.

Conditions
COMPLETED
Chronobiology of Meal Timing: Effects on Vascular and Renal Function
Description

The purpose of this study us to investigate the effects of mistimed eating on blood pressure, kidney function and vascular function.

Conditions
COMPLETED
A Phase 1, Open-Label Study to Evaluate the Effect of a Low-Fat Meal and Multiple Doses of Ciprofloxacin on the Pharmacokinetics of Vorasidenib in Healthy Subjects
Description

The objectives of this study are: * To evaluate the effect of a low-fat meal on the pharmacokinetics (PK) of vorasidenib following a single oral dose of 40 mg vorasidenib in healthy adult subjects (substudy A) * To evaluate the effect of multiple-dose ciprofloxacin (strong cytochrome P450 \[CYP\]1A2 inhibitor) on the single-dose PK of vorasidenib in healthy adult subjects (substudy B)