980 Clinical Trials for Various Conditions
The overarching intention of the Eating Disorder Genetics Initiative 2 (EDGI2) is to increase sample size, diversity, and eating disorder phenotypes. The investigators are enrolling 20,000 new participants with anorexia nervosa (AN), bulimia nervosa (BN), binge-eating disorder (BED), avoidant/restrictive food intake disorder (ARFID), and controls in the US, Mexico, Australia, New Zealand, Sweden, and Denmark. A primary study goal is to enroll at least 30% of participants from underrepresented groups. Participants are asked to complete a series of questionnaires and submit a saliva sample for genotyping. The goal is to better understand eating disorders and how they relate to each other so that better treatments can be developed.
This study consists of two phases: Phase A and Phase B. Participants are being asked to participate in both phases. Phase A of this study is comparing two formulations of a study medicine called NNC0487-0111 for weight control in people with overweight or obesity. Phase B of this study is testing how taking NNC0487-0111 at the same time as a meal affects the way NNC0487-0111 works in participants body. The aim of this study is to compare how two different formulations of NNC0487-0111 behave in the body, and how their function is affected when they are taken with or without a meal. Participants will either get NNC0487-0111 Formulation C, or NNC0487-0111 Formulation D. Both formulations are given as tablets. Which treatment participants get is decided by chance. Oral NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The study will last for about 5 - 6 months (155-184 days).
This project aims to establish the feasibility and acceptability of a comprehensive mind and body intervention; specifically a mindfulness-based interoceptive exposure (MBIE) for families of youth diagnosed with avoidant/restrictive food intake disorder (ARFID). This project will: (1) explore the feasibility of recruitment, retention, and data collection procedures with youth with ARFID at end of treatment, (2) establish the acceptability and adherence of the MBIE intervention, and (3) evaluate the number of MBIE sessions required to observe changes in the number of foods avoided and mindfulness skills.
1 in 3 adults have prediabetes in the United States, and many of them will eventually develop diabetes, which has significant public health and economic costs. However, type 2 diabetes (T2D) and prediabetes are heterogeneous groups with different pathological mechanisms, dysfunctions in different processes, and varied disease trajectories. Patient stratifications into subtypes and personalized nutrition interventions are highly needed but not yet available. Metabolic responses (e.g., glucose excursion) after food intake provide a direct observation of personal metabolic control and its association with T2D. The investigators hope to learn how prediabetes and type 2 diabetes evolve, and specifically what food or exercise can do to mitigate blood sugar response.
This study is a randomized controlledlinical trial, assessing the efficacy of cognitive- behavioral therapy (CBT-AR) and nutrition counseling for avoidant/restrictive food intake disorder (ARFID) for children and adolescents (ages 10-18 years).
The goal of this observational study is to rapidly accelerate knowledge about the biology of avoidant and restrictive food intake disorder or ARFID in children ages 7-17 and in adults. The investigators will be evaluating the genetic and environmental origins of ARFID. Participants will be asked to answer questionnaires online and to submit a saliva sample for DNA using a kit that will be mailed to their home.
The purpose of this study is to assess the validity of the PortionSize™ app to quantify children's own dietary intake and children's intake by parents or caregivers.
Randomized controlled trial of an exposure-based behavioral treatment (CBT) in adults with functional dyspepsia who meet criteria for avoidant/restrictive food intake disorder (ARFID) with weight loss.
The purpose of this study is to investigate how gut hormones and brain areas respond differently to gastric distention, tasteless calories, or palatable food and how this alters appetite.
The current project applies an integrative three-prong approach to investigate the potential of the dopamine D2 receptor (DRD2) agonist bromocriptine to: 1) increase homeostatic satiation signaling, 2) alter neural circuitry to reduce hedonically motivated food intake, and 3) examines a genetic predisposition that may markedly impact the effectiveness of this medication in those at high risk for T2DM.
Avoidant Restrictive Food Intake Disorder (ARFID) is a disorder that affects toddlers, children, adolescents, and adults. Individuals with ARFID are not able to consume an adequate amount or variety of food to a degree that it affects their mental and/or physical health. ARFID often begins in early childhood so it is important to treat children in early in life as possible to prevent any negative consequences of poor nutrition. There are currently no treatments for young children with ARFID. The investigators have developed two different study programs and the purpose of this study is to test them out and see if they help children with ARFID and to learn more about how these study programs work.
This is a pilot study to test how a growing-up formula (GUF) compares to a common nutritional supplement (NS), which is regularly used to help toddlers (ages 12-36 months) gain weight. This study will look at whether GUF helps to increase solid food intake for children who are thought to be "picky eaters" and see the effects on growth compared with the NS. To date, it is not clear if GUFs help to increase intake of solid foods. Participants will be placed into one of the two study arms: Enfagrow (GUF) or Pediasure (standard NS).
The primary objectives are to * Identify avocatin b (C17 lipid) in plasma of individuals that consumed 1 avocado. * Confirm no avocation b present in the plasma of individuals that avoided avocado intake for 7 days. * Determine the effect of an overnight fast on avocation b detection.
Background: The indirect effects of the COVID-19 pandemic on mental health are of increasing concern. Perceived stress can lead to binge eating and weight gain. Researchers want to learn more about the relationship between eating behavior and the pandemic. Objective: To study how the stress of the COVID-19 pandemic is affecting eating behaviors and weight. Eligibility: English-speaking adults ages 18 and older who have access to a computer or smartphone connected to the internet. Design: This is an online study. Participants will answer surveys through the study website. Participants will complete a one-time survey. It will ask about their experiences throughout the COVID-19 pandemic, their socioeconomic standing, their mental and physical health, and their eating habits. They will have the option to repeat the survey once a month for the next 12 months. This will show changes in their thoughts and behaviors over time. They will provide their email address to get survey links. Participants will also have the option to complete a 2-minute survey on their smartphone. They will complete the survey daily for 7 days in a row. It will ask about their stress and eating behavior in real time, in their home environment. They will provide their phone number to get survey links via text message. If a participant has taken part in a previous NIH study on the Phoenix AZ campus, they will be asked to share their first and last name, date of birth, and email address. This information will be used to connect data from this study to their past data. Participation is typically 25 minutes but may last up to 1 year. \*\*\*To participate in this study go to the REDCap study link: https://redcap.link/nihcovidstudy.\*\*\*...
The purpose of this research study is to investigate brain insulin's relationship with food intake in African Americans. Facilitating insulin's entrance into the brain through a nasal spray is currently being studied as a way to prevent or treat Alzheimer's disease. However, brain insulin may also have an impact on food intake. This study is designed to help researchers understand how different factors related to Alzheimer's disease (i.e. APOE genotype and cognitive functioning) influence brain insulin's relationship with food intake.
This is a within-subjects crossover study that examines subjective appetite, food intake, hormone and metabolic responses to consumption of mid morning snacks of pecan nuts as compared to an iso-caloric amount of tortilla chips. Pecans are high in fat and calories and low in carbohydrate by weight, while tortilla chips are mostly carbohydrate and essentially devoid of fat. These two very different nutrient profiles should elicit different metabolic and biomarker responses. The study aims to determine whether these treatments also elicit different subjective appetite and food intake responses. Participants will be healthy volunteers with overweight and obesity, a population that may be seeking healthy snacking options that are satisfying and satiating.
This study assesses the acute effects of a standardized 20-minute vaping episode compared to a non-vaping control condition on ad libitum food intake during a 30-minute buffet meal, occurring approximately 45 minutes after the vaping episode
The brain plays an integral role in how and what people eat. However, the brain's contribution to overeating is not well understood during sensitive developmental periods such as adolescence, when excessive weight gain and obesity prevalence are a significant concern.The proposed study will use functional magnetic resonance imaging to examine how the brain's response to excess energy is related to overeating in adolescents with and without obesity.
This is a study of tirzepatide in participants with obesity. The main purpose is to learn more about how tirzepatide affects the number of calories participants burn and the amount of food they eat. The study lasted for 28 weeks and will include about 21 visits to the study center.
This study determined effects of a cognitive distraction on amount, preference, and memory of food consumed and perceptions of fullness, hunger, and enjoyment of food in a healthy young-adult population. A randomized controlled crossover study of 119 healthy adults, assigned to begin in either the distracted or control condition, was conducted.
This study will evaluate the effects of retrieval-extinction (R-E) training on responding to high calorie foods including self-report craving, physiological responding, and high calorie food intake in adults with overweight/obesity. R-E training aims to update the memories that associate cues (i.e., high calorie food) with reward (i.e., consumption). R-E training involves "retrieving" these cue-reward associative memories through brief presentation of relevant cues, resulting in instability of the memories and providing an opportunity to be updated via reconsolidation. Presenting relevant cues while not allowing consumption (i.e., extinction training) during reconsolidation can modify the unstable cue-reward memories, resulting in lasting reductions of craving and intake. This study will be the first to test the effects of R-E training on craving for and intake of high calorie foods in humans. To examine the effects of R-E training on food craving, physiological response (heart rate, skin conductance, salivation), and food intake, 150 adults with overweight/obesity will complete baseline food cue-reactivity and intake tasks in the lab. Participants will be randomized to observe high calorie food cues (i.e., "retrieval" of food cue-reward memories; R-E training group) or non-food cues (i.e., no retrieval of food cue-reward memories; extinction control group) and engage in 60 min of extinction training for high calorie foods. R-E/extinction control training will occur on two consecutive days and four follow-up food cue-reactivity sessions through 3 months. Weight will be assessed at each session and in-lab food intake at 1- and 3-months. Recent food/drink intake will also be assessed at each session. Some participants (n=75) will complete a pilot portion of the study involving real-world data collection of naturally-occurring food cues, craving, and food intake via smartphone. It is hypothesized that: (1) R-E training (vs. extinction control) will decrease high calorie food cue-reactivity (self-report craving, heart rate, skin conductance, salivation) and intake assessed in the lab, as well as self-report craving and food intake assessed in the real world; and (2) decreased high calorie food cue-reactivity will be a mechanism through which R-E training reduces high calorie food intake at follow-up. The Principal Investigator will explore associations between lab and real-world cue-elicited craving and food intake, and the effect of R-E training on weight.
The aim of the study is to determine the effect of varying both the portion size and the appeal (palatability and presentation) of foods served to preschool children at a meal on the outcomes of food and energy intake at the meal.
Primary Objective: To examine whether the consumption of preloads varying in protein quality effect subsequent meal energy and macronutrient content Secondary Objectives: To examine whether the consumption of preloads varying in protein quality effect postprandial feelings of hunger, fullness, desire to eat, prospective food consumption, and eating initiation. Exploratory Objective: To examine whether the consumption of preloads varying in protein quality effect postprandial cognitive performance.
This is a randomized-controlled unblinded clinical trial to investigate dietary intervention on metabolic biomarker assessment in World Trade Center (WTC) Lung Injury (LI) in firefighters. The purpose of this study is to evaluate biomarkers of metabolic dysregulation that have previously been found to predict WTC-LI in a case cohort study selected from the entire exposed firefighter cohort, and attempt to alter these metabolites using dietary intervention and a technology-supported behavioral modification program. Investigators will measure Pre/Post global metabolic expression in WTC-exposed, symptomatic firefighter serum sampled after 6-month intervention, as well as clinical outcomes of WTC-LI in the study group vs controls.
Comparison of Capsimax™ 2mg and 4mg of capsicum extract vs. placebo on metabolic rate and satiety.
According to normal physiology, the longer fasting period allows food particles to pass stomach through small intestines to minimize intragastric content. The practice guidelines recommend 2-hour fasting period for clear fluid (including water, pulp-free juice and tea or coffee without milk), 4- hour fasting period for breast milk and 6-hour fasting period for non-human milk and solid food to reduce risks of pulmonary aspiration. As a result of longer fasting period, patients tend to experience preoperative dehydrated states and intraoperative hypotension. Patients' demographic data will be obtained from charts. Parents will be asked for type, volume of fluid/food intake and NPO time. This study will be done at BCH's Gastroenterology Procedure Unit (GPU) theaters to measure actual intragastric volume and pH at the beginning esopagogastroduodenoscopy procedures. We hope to demonstrate the relationship between NPO time and actual intragastric volume which provide sufficient data of NPO time to ensure patient's safety.
The objectives of this study are 1) to determine if consumption of mixed nuts influences food intake and choice, and 2) to determine how personality traits affect food choice, including mood, stress, tendency to seek approval, tendency toward food cravings, and approach to food intake control.
The investigators propose a randomized, tightly-controlled breakfast trial in normal to overweight adults that will test whether the consumption of various types of protein-rich meals, containing \~24g of protein, will differentially alter food intake and meal initiation through proposed appetite and satiety mechanisms. Aim 1: To examine whether the consumption of protein-rich meals that vary in protein quality (source) effect: 1. postprandial feelings of hunger, fullness, desire to eat, prospective food consumption 2. postprandial fluctuations in key appetite and satiety hormones 3. eating initiation (i.e., motivation to eat (again)) 4. food cravings Aim 2: To examine whether the consumption of protein-rich meals that vary in protein quality (source) effect: 1. energy intake and food choice within the breakfast meal 2. energy intake and food choice at the next eating occasion 3. energy intake and food choice across the entire day
This study will determine whether changes in energy balance alter regional neuronal activation of brain regions associated with food intake in individuals screened to be either resistant or prone to obesity. Specifically, it will determine whether foods of "hedonic" value elicit changes in regional neuronal activity in the fasted and fed state in "obese-resistant" and "obese-prone" men and women in varying states of energy balance.
The objective of this study is to determine how the protein source and the physical form of food consumed at breakfast impact food intake. Research will be conducted by assessing feelings of hunger, food preference and blood glucose in healthy adults following the ingestion protein-based (animal versus plant) drinks similar calorie and protein content.