Kannapolis

Researchers are evaluating whether eating avocados by breastfeeding mothers can provide important nutrients in human milk that support brain development in their infants. This interventional study involves healthy lactating women around 13 weeks postpartum and their infants. The goal is to see if mothers will consume five avocados a week for 12 weeks and to measure the presence of choline, lutein, and fatty acids in their milk. The study also aims to assess cognitive benefits in infants whose mothers eat avocados compared to those who do not. Mothers will be randomly assigned to either an avocado group, where they consume one avocado daily for 12 weeks, or a comparison group with no avocado intervention. Participants will visit the lab three times over six months at enrollment around 3 months postpartum, 4.5 months, and 6 months. Milk samples will be collected biweekly and picked up from participants, with the avocado group receiving new avocados at each pickup. Mothers will also provide diet information during these visits. Infants will undergo cognitive tests including a recognition memory test at 6 months and the Bayley Scales of Infant Development at 4.5 months. Mothers will complete temperament questionnaires at 3 and 6 months. Saliva samples will be collected, and researchers will monitor changes in choline, lutein, and fatty acid levels in milk. The study will track adherence to avocado consumption and measure infant cognitive development over the six-month period.

Researchers are investigating the effects of daily blueberry intake combined with or without moderate exercise on cognitive function in older adults experiencing age-related cognitive changes. This clinical trial explores whether a diet rich in flavonoids and regular physical activity can improve cognition and reduce decline through changes in the gut microbiome. The study is randomized, double blind, and placebo controlled, focusing on healthy older adults aged 65 to 85 with mild cognitive decline. Participants will be randomly assigned to one of four groups for 12 weeks blueberry powder plus walking exercise, blueberry powder plus stretching exercise, placebo powder plus walking exercise, or placebo powder plus stretching exercise. The blueberry dose is 50 grams of freeze-dried powder daily, equivalent to two cups of fresh blueberries. Exercise sessions last 45 minutes each, five times per week, and are supervised. Both supplements and exercises are carefully monitored and designed to assess their combined or separate effects. Throughout the study, participants undergo multiple assessments including cognitive testing with the MoCA and CANTAB batteries, electrophysiological measures using a sensor net, and evaluations of aerobic fitness. Blood, urine, and stool samples are collected before the study begins and at 6 and 12 weeks to analyze gut microbiome changes and blueberry metabolites. Daily step counts are tracked via FitBit, and adherence to the supplement and exercise protocols is regularly checked. The main outcome is the change in cognitive function from baseline to 6 and 12 weeks.

Researchers are studying the effects of the dietary supplement SPM Active4, which contains omega-3 polyunsaturated fatty acid derivatives, in adults with obesity. The study focuses on whether taking 2 grams daily for 12 weeks increases levels of specific monohydroxylated derivatives 14-HDHA, 17-HDHA, and 18-HEPE that may help reduce chronic inflammation. It also aims to assess changes in self-reported burnout, life satisfaction, and sleep quality in participants aged 45 to 60 with a body mass index BMI between 30 and 40 kgm. Participants will take two soft-gel capsules of SPM Active4 each day for about 12 weeks, with a small window of a few days. Blood samples will be collected after fasting for 12 hours, both before and after the supplementation period, to measure levels of the omega-3 derivatives. Validated surveys evaluating burnout, life satisfaction, and sleep quality will be completed by participants at the start and end of the intervention. Throughout the trial, participants will provide fasting blood samples and complete questionnaires to track changes related to the supplement. Researchers will monitor the blood levels of the targeted fatty acid derivatives and assess participant well-being using validated survey scores. The study is sponsored by the University of North Carolina, Chapel Hill, and participation lasts for the 12-week supplementation period plus assessments at baseline and study completion.

Researchers are examining the feasibility of a 6-month digital program called Centering Appetite designed to improve blood sugar control HbA1c and reduce binge eating in African American adults with type 2 diabetes who report uncontrolled eating. This randomized clinical trial will assess recruitment, attendance, retention, program adherence, and participant satisfaction with the intervention. Participants will be randomly assigned to receive either the Centering Appetite intervention or a control program. The intervention includes two telehealth group sessions focused on relearning hunger and fullness signals, glucose monitoring, and carbohydrate management, supported by monthly booster sessions and weekly interactive lessons through a digital app. Participants also receive a Fitbit to track daily physical activity. The control group will attend two diabetes education sessions and receive weekly nutrition tutorials via email. Throughout the study, participants will be monitored for attendance, retention, and adherence to the program. Researchers will measure changes in HbA1c, weight, blood pressure, and binge eating episodes at the beginning and end of the six months. Satisfaction with the program delivery and content will also be evaluated. The study aims to provide insights into the acceptability and practicality of using digital tools to support diabetes self-management and appetite regulation.

Researchers are studying how individual people respond to different diet patterns by using artificial intelligence and machine learning. The Nutrition for Precision Health NPH study includes a large group of adults who provide detailed health and lifestyle data, along with two smaller groups that follow specific diet plans under controlled conditions. The goal is to predict metabolic responses to meals by analyzing data from clinical, molecular, behavioral, environmental, and social factors. Participants in the study are divided into three modules. Module 1 is observational and collects baseline health data over 8 to 10 days. Module 2 involves 1,200 participants living in their own homes who follow three different diets each for about two weeks, with at least two weeks in between, while all meals are provided. Module 3 includes 150 participants who live in a residential research setting and follow the same three diets under full supervision. Both modules include meal tests to measure glucose, insulin, triglycerides, and GLP-1 responses. During the study, participants provide blood samples at multiple times after meal tests and wear devices to monitor activity and glucose levels. Data collected includes biospecimens, questionnaires, and physical measures. The study also compares various dietary assessment tools for accuracy and ease of use. The entire process for Modules 2 and 3 can last up to six months, including diet periods and washouts, with researchers measuring metabolic responses to better understand how diet affects health.

Researchers are evaluating the impact of atorvastatin, a cholesterol-lowering drug, on preventing death, dementia, and persistent disability in adults aged 75 years and older who do not have cardiovascular disease or dementia. This large, randomized, placebo-controlled phase 4 study aims to understand the benefits of statins in older adults living in the community. The trial also examines secondary outcomes such as mild cognitive impairment and cardiovascular events. Participants will be randomly assigned to receive either atorvastatin 40 mg daily or a matching placebo. The study plans to enroll about 20,000 participants from around 100 sites across the U.S., including both VA and non-VA locations. The treatment will continue for up to 5 years, with the median follow-up estimated at 3.8 years. Study drugs will be mailed directly to participants every 90 days to support adherence, and telehealth enrollment options are available. Participants will undergo initial assessments including physical function tests and blood draws for lipid panels. Follow-up assessments will occur annually by phone to monitor cognitive and physical function, with in-person visits if needed. Cardiovascular events and other health outcomes will be tracked through electronic health records and national databases. The main outcomes measured include the number of participants without new diagnoses of dementia or persistent disability after 4 years. Safety and adherence are monitored through regular contact and data collection throughout the study period.

Researchers are evaluating the effects of high avenanthramide ancient oat Royal Ancient Oats17 muffins compared to conventional oat muffins on blood sugar control and related metabolic factors. This randomized, two-period crossover trial includes 38 non-diabetic adults aged 35 to 65 years who are overweight or obese. The study aims to detect differences in post-meal blood sugar response between the two muffin types and white wheat flour muffins. Participants will first consume white wheat flour muffins for three days to establish a baseline. Then, they will be randomly assigned to receive either Royal Ancient Oats17 muffins or conventional oat muffins in different orders during the two study periods. This crossover design allows each participant to experience both muffin types. The study treatments are provided as dietary supplements in muffin form. Throughout the 2-week study, participants will be monitored for their blood sugar response after eating the muffins, as well as for hormone levels related to digestion and feelings of fullness. The research includes repeated measurements and assessments of metabolic parameters. Participants will follow study procedures carefully, limit intake of certain fiber-rich and high-carbohydrate foods, and avoid supplements or medications that could affect blood sugar. The sponsor is Standard Process Inc.

This research aims to evaluate whether supplementing breastfeeding mothers and their infants with whole egg powder, rich in nutrients like choline, lutein, and docosahexaenoic acid, supports optimal brain development. The study involves 84 mother-infant pairs, focusing on infants 3 months postnatal, comparing whole egg powder to egg white powder as a control. The purpose is to understand the combined activity of these nutrients in human milk and their impact on infant cognition. Participants are randomly assigned to receive either whole egg powder or egg white powder, with mothers consuming the equivalent of five servings per week for three months. Visits to the lab occur three times at infant ages 3 months, 4.5 months, and 6 months. During these visits, various samples including milk, saliva, and plasma are collected from mothers, while saliva and plasma are collected from infants. Diet intake is monitored via questionnaires and screening tools throughout the study. Infants undergo a recognition memory test using electrophysiology at 6 months and are assessed with the Bayley Scales of Infant Development at 4.5 months. Mothers complete temperament questionnaires at 3 and 6 months. Researchers track dietary intake, biological samples, and developmental outcomes to measure the effects of the nutrient supplements. The total study duration for each dyad spans three months, with detailed monitoring and assessments at each visit.