34 Clinical Trials for Various Conditions
The goal of this clinical trial is to evaluate the effects of consuming meat and eggs from regenerative/pastured versus conventional farming practices on health biomarkers in middle-aged adults. The main questions it aims to answer are: How does consumption of pastured animal products influence red blood cell omega-3 fatty acid levels, inflammatory markers, and metabolomic profiles compared to conventional animal products? What are the potential metabolic health benefits or risks associated with consuming animal products from regenerative farming practices? Researchers will compare participants consuming pastured meat and eggs to those consuming conventional meat and eggs to determine differences in health outcomes. Participants will: Consume study-provided chicken thighs, ground beef, ground pork, and eggs for 16 weeks. Attend clinic visits for blood, urine, and stool sample collection before and after the intervention. Complete dietary assessments to monitor compliance.
Background: Many people in the United States are overweight or obese. This natural history study will look into how life events during childhood can impact eating behaviors and weight gain as adults. Objective: To explore how childhood experiences affect adult eating behaviors. Eligibility: Healthy people aged 18 to 60 years. Design: Participants will have 3 clinic visits. They will be screened with blood tests. They will answer questions about their alcohol and tobacco use. At the next visit, participants will undergo these activities: Parts of their body (such as waist, neck, and thighs) will be measured with a tape. They will have an imaging scan to find out how much body fat they have. They will start wearing a device like a wristwatch that measures their physical activity. They will wear this device for up to 10 days. They will wear a device on their upper arm or belly that measures blood glucose (sugar) levels. Participants will wear this for 7-10 days. They will answer questions about their education, childhood, and routines. They will receive a kit to collect a stool sample at home. At the last visit, participants will have these tests: Participants will relax and breathe normally while wearing a clear, plastic canopy that fits over their entire head. Blood samples will be taken before and after participants drink a sugary drink. Participants will be offered a large selection of foods for lunch. They will eat as much as they want. Then they will answer questions about how they feel about food and themselves.
Advancing age is associated with gut dysbiosis, low-grade chronic inflammation, progressive insulin resistance, and increased risk of type 2 diabetes (T2D). Prediabetes is present in 45-50% of middle-aged/older adults, and declines in glucose tolerance are evident in the third or fourth decade of life. Thus, there is an urgent need to identify new approaches for the prevention of type 2 diabetes among middle-aged adults. Observational research has linked intake of ultra-processed foods (UPF), which comprise \~60% of total energy intake in US adults, with increased risk of T2D. Ex vivo and animal research suggests that components of UPF alter gut microbiota composition and initiate a cascade of events leading to intestinal inflammation and impaired glycemic control. Whether mid-life adults (aged 45-65 yrs) are susceptible to the adverse impact of UPF consumption on glucose homeostasis is unknown. The overall objective of this study is to establish proof-of-concept for an impairment in glucose homeostasis following increases in UPF consumption in mid-life adults, in order to conduct a larger, more comprehensive and mechanistic trial in the future. In addition, changes in gut microbial composition and function, intestinal inflammation and permeability, serum endotoxin concentrations, and inflammatory cytokines as potential mechanisms by which UPF consumption influences glucose homeostasis will be investigated.
This one time pilot laboratory study focuses on examining the relationship between different types of physical tasks and taste perception of high and low-calorie foods among hungry individuals.
This study is a test of possible mechanisms by which calorie labels might lead people to increase calorie intake. The investigators hypothesize that calorie labels might increase calorie intake because 1) people infer that higher calorie foods are tastier, 2) calorie labels invoke thoughts of dieting, leading people to overconsume as a reaction, 3) people try to maximize calories consumed per dollar spent, and 4) calorie labels change one's goal motivation toward food, causing people to eat more.
Online survey for 11-17 year olds about behavior, sleep, and food consumption patterns. This survey can be completed on any computer that has internet access.
The purpose of this study is to examine the role of stress in food craving and food consumption in obesity. Using experimentally validated guided imagery procedure, the investigators propose to examine the stress response using subjective, physiological and neurobiological measurements.
The purpose of this study is to assess the effects of peer influences on snack purchases in adolescents. During the session teens will be given a certain amount of money to use to purchase foods and beverages in a hypothetical convenience store setting. The investigators hypothesize that overweight youth will be less responsive to own-price elasticity for high calorie foods and less likely to show cross price elasticity for low calorie foods when the price of the high calorie for nutrient foods increases. The investigators also predict that overweight youth will show more cross price elasticity for low calorie foods when in the presence of peers; whereas lean youth's food purchases and price sensitivity will not be affected by the presence of peers.
The aims of this project are to: 1. Determine if 3-weeks dietary supplementation with NOPE-EGCG (PhosphoLEANtm, 85mg NOPE+50mg EGCG per capsule) versus a placebo will improve performance on impulsivity, go/no-go tasks and negative outcome learning in heavy drinkers. 2. Evaluate whether supplementation with NOPE-EGCG versus placebo results in reductions in alcohol consumption. 3. Preliminary data in the rodent model suggests that rats treated with OEA shift preference for lower fat test stimuli. In aim 3 we will Determine if 3-weeks of supplementation with PhosphoLEAN shifts fat preference towards lower fat test puddings.
The aim of this clinical trial is to assess the effects of daily consumption of soy protein foods on body composition, general health status and dietary intake outcomes in generally healthy children.
The Mexican Consulate runs a Ventanilla de Salud (VDS) (Health Window) program in fifty locations nationwide. The VDS provides an opportunity to provide health services to members of the Mexican community. Some of the concerns previously identified during the work at the VDS were that some individuals did not always get enough to eat, or do not always have enough money for food. This sometimes leads to unhealthy food choices-- buying and preparing foods that are inexpensive but really not good for the particpant. The investigators would like to conduct focus group to help make changes to a new diet and exercise program at the VDS called SANOS which stands for SAlud y Nutrición para todOS. SANOS aims to provide information for living a healthier lifestyle including on how to eat healthy on a small budget and how to become more physically active. The hope is that learning to eat healthy without spending a lot of money and to find simple ways to increase physical activity (like walking) will be a first step in reducing obesity rates within the Mexican community that have led to increased risks for cancer, cardiovascular disease, and diabetes. Participants who reached 6-month follow-up during the COVID-19 pandemic, may be outside of the 12-month window post 6-month follow-up, and have not been able to complete HgbA1c and cholesterol measures will be invited to complete these measures in person at the VDS.
The changing food environment, with increasingly abundant ultra-processed food (UPF) options, may directly contribute to rising rates of obesity, though it is unknown which ingredients in UPF elevate their reinforcing nature in a way that may lead to overconsumption. The proposed study is the first to systematically examine differences in the rewarding characteristics of and physiological and metabolic responses to UPFs that are high in fat, refined carbohydrates (like sugar), or both. Understanding the biobehavioral underpinnings that enhance the reinforcing potential of ingredients in UPF (e.g., fat vs. refined carbohydrates) can inform novel intervention targets for the treatment of overeating and obesity.
This is a randomized trial to to test the degree to which visual attention to unhealthy foods, racially congruent people, and/or "likes" in social media ads explains the relationship between ad exposure and calorie intake.
The main purpose of the study is to look at the effect of the study drug compared to placebo on calorie intake, energy metabolism, and appetite. The study will last up to 6 months and may include up to 20 visits.
Peanut allergy is the most common cause of fatal and near-fatal food-allergic reactions and egg allergy is among the two most common causes of food-induced anaphylaxis. The proposed research will explore the development of sensitization to these food(s) in infants based on maternal consumption or avoidance during pregnancy and breastfeeding.
Randomized and controlled experimental study to evaluate how influencer food ads on TikTok affect calorie purchases among youth (ages 10-13). Participants will be randomized to one of two conditions: (1) seeing an influencer with food or (2) seeing an influencer without food. Participants will complete a 15-minute survey in which they will be randomized to one of two conditions and view and rate TikTok influencer ads associated with their condition. Then they will complete a food purchasing task in which they will shop in an online store that will display six food items and six beverages. Finally, they will answer demographic questions (e.g., self-reported height and weight) and view a debriefing summary that describes the full purpose of the study.
This project is a research study looking at what foods students choose and eat during school lunch and examines how salad bars impact what children eat.
The objective of this research was to determine if adding a plate graphic depicting the components of the Eat Lancet Planetary Health diet (Figure 1) to food labels in Stanford University dining halls would lead to dining hall patrons making dietary decisions that better resemble the Planetary Health diet in comparison to a no signage control group. The study hypothesis was that presenting students with a plate graphic featuring the healthy reference diet would decrease objective measures of the amount of meat taken and therefore the environmental impact of student meals.
The aim of this study is to determine the degree to which sugar-sweetened beverages (SSB) warning labels increase consumers' knowledge about the potential health harms of SSBs and reduce SSB purchases and consumption. 216 racially and ethnically diverse parents of children 6-11 years old will be recruited to buy snacks and beverages for four weeks via an online store that ships participants their purchases. Participants will be randomized to either 1) calorie labels (control); or 2) sugar graphic warning labels. The investigators hypothesize that sugar graphic warning labels displayed in an online store in weeks 2-4 will lead to the greatest reductions from week 1 across both primary outcomes compared to the control group that will only see calorie labels.
The aim of this project is to assess the effectiveness of the fruit and vegetable (FV) gardening component of the Preventing Obesity by Design strategy to support preschool fresh fruit and vegetable knowledge, liking and consumption, and physical activity in children 3-5 years old living in under-resourced communities and attending childcare using a Randomized Controlled Trial research design. Sample: 15 childcare centers, 286 children.
This study aims to compare the effectiveness of two interventions to address food insecurity among low-income families with young children during the COVID pandemic. The investigators will conduct a parallel group, randomized controlled trial of 250 families. The first randomly assigned comparator is Fresh Connect, a produce prescription program that provides a stipend for participants to purchase fresh food items at mobile markets and independent farmers markets across Boston. The second comparator is grocery store gift cards, redeemable at conventional grocery stores. In each comparator, participants will be given the equivalent of $150 on a monthly basis for six consecutive months. All participants will be followed for 12 months to assess outcomes that involve food insecurity (primary), fruit and vegetable consumption, healthcare utilization, social service utilization, and physical/emotional health.
The investigators are examining the effects of potato consumption on indices of glycemic control and cardiovascular health in overweight and obese individuals with type two diabetes mellitus (T2D) to provide feasible and effective dietary ways for individuals to enhance their quality of life. The overall objective of this crossover study is to collect data regarding the effects of potato consumption on indices of glycemic control and cardiovascular health among overweight and obese individuals with T2D. The central hypothesis of this crossover study is that the daily consumption of 100 g white potato for 12 weeks will contribute to improvements in glycemic control, reductions in inflammation, and improvements in blood lipids and vascular function in overweight and obese individuals with T2D compared to a macronutrient-matched refined grain (75 g cooked long-grain white rice) for 12 weeks (with a 2 week washout period between interventions). Specific Aim) The assessment of blood glucose control, vascular function, body composition and overall cardiovascular risk after consumption of potatoes (100g/d for 12 weeks) in individuals with T2D compared to a calorie matched refined grain at the initial baseline visit as well as the 6-, and 12-week study visits (for each 12-week intervention period). This aim will assess changed in blood glucose, insulin, HbA1c, HOMA-IR, and HOMA-β as well as the following: 1. blood pressure (BP) 2. markers of endothelial function \[flow-mediated dilation (FMD), pulse wave velocity (PWV), and endothelin-1 (ET-1)\] 3. markers of inflammation (C-reactive protein) 4. body composition via bioelectrical impedance (BIA), lean mass and fat mass assessment 5. lipid profiles, consisting of total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and oxidized LDL (Ox-LDL). Atherogenic risk ratios (TC/HDL-C, LDL-C/HDL-C, HDL-C/LDL-C) will also be assessed 6. anthropometrics \[weight, height, waist circumference (WC), hip circumference (HC), waist-to-hip ratio (WC/HC)\]
The objective of this study is to examine how infant egg consumption (age of introduction and frequency of intake) influences physical growth, obesity, cardio-metabolic health, risk of food allergy, and cognition development in mid-childhood and adolescence.
To assess smoking, vaping, and alcohol consumption behaviors via online surveys in the population. Further, the objective is to administer additional surveys to assess which methods (e.g., pen-and-paper records, a smartphone app) for monitoring smoking, vaping, alcohol intake, and food intake are preferred by the study population.
Lowering sugar-sweetened beverage (SSB) consumption is a central component of lifestyle behavior change aimed at preventing and managing obesity, yet effective reduction of SSB intakes has been met with many challenges. While their palatability, accessibility, publicity, affordability, and social acceptability contribute to frequent and sustained SSB consumption, their caffeine and sugar content may further encourage continued intake. Although adverse health consequences of excessive SSB consumption are well documented, the extent to which their pleasant taste (due primarily to their sugar content) and post-ingestive effects (due to their sugar and/or caffeine content) positively reinforce consumption among children has not been elucidated. The purpose of this study is to conduct a pilot intervention to examine the feasibility of removing caffeinated SSBs from the child diet and to explore whether caffeinated SSB removal induces withdrawal symptoms in 8-11 (3rd-5th grade) year old children. Participants will be randomly assigned to replace their usual caffeinated SSB consumption with either caffeinated SSBs, caffeine-free SSBs or sparkling water provided by the study team for two weeks.
This research is a randomized pilot study of an intervention to address food insecurity among intermediate risk Boston Accountable Care Organization (BACO) members receiving primary care at Boston Medical Center (BMC). The investigators propose a parallel group, randomized pilot study among intermediate risk Medicaid ACO patients at BMC who have experienced food insecurity in the past 12 months, with a total enrollment of 120 participants (N=120). Half of the pilot study participants (n=60) will receive usual care: tailored printed paper referral guides to address health-related social needs, including resources for food insecurity (via the Health System's THRIVE Screening \& Referral Program) and referrals to Boston Medical Center's Preventative Food Pantry. The other half (n=60) will receive access to a mobile fresh produce market and a monthly stipend to purchase items available on the mobile food trucks. This pilot study will partner with Fresh Truck, a Boston-based 501(c)(3) organization that deploys mobile fresh produce trucks throughout Boston neighborhoods. Fresh Truck recently launched a new system, called 'Fresh Connect,' which addresses affordability as a barrier to healthy eating. 'Fresh Connect' enables healthcare systems to pay for fresh produce purchased by their patients from the Fresh Truck mobile markets. The study protocol comprises three steps: * Risk stratification before consent process to determine if the patient, at baseline, is within the top 3-20% of cost and utilization among BACO members. (This process is part of usual care operations in the Health System for ACO members). * Of BACO patients identified as intermediate risk, patients will be screened for proximity to Fresh Truck mobile markets (zip code is among current Fresh Truck service area), nutritional need (food insecurity identified in the last 12 months), and not documented as housing insecure. * Half the pilot study population will receive access to a mobile fresh food market intervention, Fresh Truck, and a stipend to purchase fresh produce aboard the trucks. The other half will receive usual care. Pilot study participation is 6 months and will include collection and measurement of data from the following sources: baseline interview; final (6-months post-enrollment) interview, electronic medical records (EMR), BMC Clinical Data Warehouse (BMC CDW), and BMC HealthNet Plan (BMCHP) claims.
Quality nutrient intake is essential for proper development and well-being of children in all aspects of health, including cognitive development. Eggs are of particular interest based on potential cognitive and neurological benefits due in part to significant concentrations of choline and lutein. While overall, choline and lutein have received considerable attention in the literature in relation to cognition and brain function, most studies involving intake in young adults have had short intervention periods ranging from 90 minutes to 3 days. Food insecurity has been associated with decreased academic performance. Given that populations with food insecurity have limited resources to direct towards nutrition, identifying how a widely available, highly versatile and largely affordable source of nutrients (i.e. eggs) may have favorable impacts on cognitive function and brain function will be valuable in informing public health recommendations in this at-risk population. As such the investigators will examine whether an increased egg consumption dietary prescription can have positive effects on functional activity (i.e. fMRI) during an Eriksen-Flanker task, anatomical changes in the brain (i.e. DTI, MRI), and cognitive abilities as measured by the Stop Signal Reaction Time task, Operation Span task, Raven's Progressive Matrices and the Boston Naming Task.
University of Wyoming (UW) and Wyoming Food for Thought Project (WFFTP) propose to collaboratively develop, pilot, and evaluate a trial on the impact of market vouchers on food security and fruit and vegetable (F\&V) consumption. We will (a) provide farmers market vouchers to families who are enrolled in WIC, SNAP, or free or reduced lunch and/or have incomes ≤185% of poverty line; (b) assess impacts of these supports on household food security and F\&V consumption; and (c) test feasibility and impacts of vouchers valid only for F\&V vs. for any foods that can be purchased with SNAP. To test the feasibility and preliminary impacts of this approach, we will enroll 30 individuals/households in this study, randomizing 10 to each of the 2 intervention arms and 10 to waitlist control. Qualifying individuals and families will be able to enroll in the study at the WFFTP Tuesday afternoon/evening market on July 30th, 2019. They will be randomized upon enrollment to one of three conditions: receiving $20 in vouchers at each of up to 4 markets ($80 total) that are good for F\&V only, receiving $20 vouchers at each of up to 4 markets that are good for any foods that SNAP/EBT benefits can be used for; or delayed intervention/waitlist control (who, at the final data gathering, will receive 5 x $20 in vouchers good at the WFFTP 2019 and 2020 markets).
The investigators propose an efficacy study (i.e., do salad bars work under controlled conditions in naturalistic settings) to test whether introducing salad bars in elementary, middle, and high schools that have never had salad bars affects students' FV consumption and waste during lunch. A cluster randomized controlled trial will test new salad bars against controls for 6 wks, with/without an additional 4-wk marketing phase .
This study will investigate fat taste and if free fatty acids (FFA) in food function as a signal for fat content. FFA are quite unpleasant - the investigators want to measure if the concentration in different foods correlates with hedonic preference. FFA concentration from a variety of foods will be used to determine if people who have greater sensitivity for FFA find foods with higher FFA concentrations less acceptable. Further, this study with determine whether the relationship between fat taste and hedonic food preference is modified by sex and body mass index (BMI).