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Found 8 Actively Recruiting clinical trials
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This research aims to establish avocado as a whole food supplement for breastfeeding mothers to enhance the nutrients in human milk that support infant brain development. The study focuses on how choline, lutein, and fatty acids work together to improve brain function and cognitive development in infants. Healthy lactating women 13 weeks postpartum and their infants will participate to determine if maternal avocado consumption affects nutrient levels in milk and infant cognition compared to mothers who do not consume avocado. Mothers will be randomly assigned to consume five avocados per week for 12 weeks or to a non-avocado group. Participants will receive avocados bi-weekly and provide milk samples and diet information every two weeks. Infants will be tested for cognitive abilities using recognition memory tests and the Bayley Scales of Infant Development at 4.5 and 6 months. Mothers will also complete temperament questionnaires, and saliva samples will be collected. Participants will visit the lab three times over six months: at enrollment (3 months postpartum), 4.5 months, and 6 months. Researchers will monitor milk nutrient changes, infant cognition, and maternal temperament. The primary outcomes include infant recognition memory and changes in choline, lutein, and fatty acid content in breast milk. The study also tracks participant adherence and collects bi-weekly milk samples for analysis.
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Researchers are investigating how eating flavonoid-rich blueberries combined with regular moderate exercise might improve cognitive function in older adults experiencing mild cognitive decline. This randomized clinical trial focuses on understanding whether this combination can enhance cognition through changes in the gut microbiome. The study includes healthy, inactive adults aged 65 to 85 with mild cognitive decline, aiming to explore the interactions between diet, exercise, and brain health over 12 weeks. Participants will be randomly assigned to one of four groups: blueberry powder with walking, blueberry powder with stretching, placebo powder with walking, and placebo powder with stretching. They will consume 50 grams of freeze-dried blueberry or placebo powder daily and engage in supervised physical activity sessions five times a week for 45 minutes each. Walking sessions will focus on brisk walking outdoors or indoors, monitored by heart rate trackers, while stretching sessions will include guided flexibility exercises. The trial uses a double-blind, placebo-controlled design to ensure unbiased results. Throughout the study, participants will attend multiple lab visits for cognitive and fitness testing, sample collection, and questionnaires. Tests include cognitive assessments using the Montreal Cognitive Assessment (MoCA) and the Cambridge Neuropsychological Test Assessment Battery (CANTAB), electrophysiological measurements, and cardiorespiratory fitness evaluations. Blood, urine, and stool samples will be collected to analyze gut-derived metabolites and microbiome profiles. Participants will also track daily steps using FitBit devices. The primary outcome is measuring changes in cognitive function from before the study to 6 and 12 weeks into the intervention.
Actively Recruiting
Researchers are studying whether daily supplementation with SPM Active4, an omega-3 polyunsaturated fatty acid (n-3 PUFA) dietary supplement, can increase certain beneficial fatty acid derivatives and improve well-being in adults with obesity aged 45 to 60 years. The study focuses on measuring changes in plasma levels of monohydroxylated n-3 PUFA derivatives (14-HDHA, 17-HDHA, and 18-HEPE) and assessing effects on burnout, life satisfaction, and sleep quality. This research includes both male and female participants with a body mass index (BMI) between 30 and 40 kg/m b2. Participants will take two soft-gel capsules of SPM Active4 daily, providing a total of 2 grams per day, for 12 weeks with a timing window of plus or minus 2 to 4 days. The capsules contain specialized pro-resolving mediators derived from n-3 PUFAs. The study does not include a placebo or comparator group; all participants receive the supplement. Blood samples are collected while fasting for 12 hours before starting and after completing the supplementation period. During the study, participants provide fasting blood samples at the beginning and end of the 12-week treatment to measure plasma fatty acid derivative levels. They also complete validated surveys evaluating burnout, life satisfaction, and sleep quality at these two time points. The research is conducted at the UNC Nutrition Research Institute in Kannapolis, North Carolina. The primary outcome is the change in plasma levels of the specific monohydroxylated derivatives, and secondary outcomes include improvements in the self-reported surveys.
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Healthy Volunteer
This research aims to evaluate the feasibility and acceptability of a 6-month digital program called Centering Appetite designed to improve glucose control (HbA1c) and reduce binge eating in African American adults with type 2 diabetes who report uncontrolled eating. The trial will assess recruitment, attendance, retention, adherence to the program, and participant satisfaction with the intervention content and delivery. Participants will be randomly assigned to either the Centering Appetite intervention group or a control group. Those in the intervention group will receive type 2 diabetes education, lessons on appetite self-regulation, and strategies for glucose monitoring and carbohydrate management through a digital app. They will attend two main sessions, monthly booster sessions, and receive weekly messages and interactive activities. Participants will also be provided with a Fitbit to track daily physical activity. The control group will receive two intervention sessions and weekly nutrition tutorials over the 6 months. During the study, researchers will monitor participants' recruitment and retention rates, attendance at sessions, adherence to the study protocols, and satisfaction with the program. Assessments will include measures of HbA1c and binge eating behaviors. Follow-up will take place at six months to evaluate the program's feasibility and acceptability among the participants.
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Researchers are developing artificial intelligence and machine learning algorithms to predict how individuals respond to different diet patterns using extensive data across behavior, social, environmental, clinical, and molecular factors. This large-scale Nutrition for Precision Health study includes an observational phenotyping group and two controlled feeding intervention groups, aiming to uncover biological features that influence metabolic responses to diet. The primary focus is on measuring responses of glucose, insulin, triglycerides, and GLP-1 after standardized meal tests following different diets. Participants in the intervention groups consume three distinct diets—Diet A (rich in fruits, vegetables, whole grains, and beans), Diet B (high in refined grains, meats, sugary drinks, and processed foods), and Diet C (moderate-high vegetables, meats, nuts, and fats)—in a crossover design with washout periods. Module 2 participants follow these diets at home, while Module 3 participants live in a supervised residential setting to allow closer monitoring. Each diet period lasts about two weeks, separated by at least a 14-day washout. Throughout the study, participants undergo comprehensive assessments including blood sampling during post-meal tolerance tests, wearable sensor monitoring, biospecimen collection, and questionnaires. Researchers analyze metabolic response curves over four hours after meals to evaluate individual variability. The study also assesses the accuracy and acceptability of technology-based dietary assessment tools. Total participation may last up to six months depending on the module.
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Healthy Volunteer
Researchers are evaluating the effects of atorvastatin 40 mg compared to a placebo in older adults aged 75 years and above who live in the community without cardiovascular disease, dementia, or significant disability. This Phase 4 study aims to determine if statins can reduce death, dementia, persistent disability, mild cognitive impairment, and cardiovascular events. The study involves about 20,000 participants across roughly 100 US sites, including both VA and non-VA locations, with inclusion of English or Spanish speakers. Participants will be randomly assigned to receive either atorvastatin 40 mg daily or a matching placebo. The study drug will be mailed directly to participants every 90 days starting immediately after randomization and continuing as long as the participant remains on the study drug. Enrollment and follow-up may include in-person visits or telehealth options. Baseline assessments include physical function tests, cognitive and physical function phone screens annually, and blood samples for lipid panels and biorepository specimens. Lipid testing is repeated at 3 months in a subset of participants. During the study, researchers will collect data through phone assessments, electronic health records, Medicare records, and the National Death Index to monitor cognitive and physical function, cardiovascular events, and other outcomes. Participants will be followed for up to 5 years, with an estimated median follow-up of 3.8 years. Safety and adherence will be supported by centralized recruitment, retention efforts, and direct mailing of study medication, with ongoing monitoring for dementia diagnosis, disability, and cardiovascular events.
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Healthy Volunteer
Researchers are investigating how high avenanthramide ancient oat muffins (Royal Ancient Oats173 muffins) compare to conventional oat muffins and white wheat flour muffins in controlling blood sugar levels after eating. The trial focuses on healthy adults aged 35 to 65 who are overweight or obese but do not have diabetes. The study aims to understand how these different muffins affect glycemic response and related metabolic measures. The study is a randomized, two-period crossover trial with a baseline run-in phase. Participants first consume white wheat flour muffins for three days to establish baseline measures. Then, 38 participants are divided evenly into two groups: one group eats conventional oat muffins and the other eats Royal Ancient Oats173 muffins. Researchers will compare the effects of these muffins on blood sugar control over the course of the study. Participants will undergo repeated measurements of their blood sugar response after eating the muffins, with a focus on the area under the curve (AUC) for glycemic response. They are asked to limit intake of high-fiber and high-carbohydrate foods and avoid certain supplements and medications that could affect metabolism. The study monitors adherence, metabolic parameters, and safety throughout the trial, which lasts about two weeks.
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Healthy Volunteer
Researchers are studying how nutrients found in whole eggs can support brain development in breastfeeding mothers and their infants. The study focuses on mothers who are 3 months postnatal and their healthy infants aged 12 to 15 weeks. The goal is to see if supplementing with whole eggs compared to egg whites affects infant cognitive development, including memory and temperament. Mothers will be randomly assigned to consume either whole egg powder or egg white powder, equivalent to 5 eggs or egg whites per week, for a period of 3 months. The study includes three visits to the lab when the infant is approximately 3 months, 4.5 months, and 6 months old. At these visits, samples of milk, saliva, and blood will be collected from mothers and infants for nutrient analysis. During the study, infants will undergo a recognition memory test using electrophysiology at 6 months and will be assessed with the Bayley Scales of Infant Development at 4.5 months. Mothers will fill out temperament questionnaires at 3 and 6 months. Diet data will be collected at each visit to monitor intake. The study measures memory performance and brain activity related to nutrient intake during early development.