College Station

Researchers are investigating a wearable device designed to noninvasively monitor insulin levels through sweat. Insulin is an important hormone that controls blood sugar and energy use, and its imbalance is linked to conditions like diabetes and obesity. By tracking insulin outside the body, this study aims to improve personalized nutrition and health management, offering a new way to understand individual responses to food without blood draws or lab tests. The study involves developing and testing a wearable sensor that stimulates sweat and measures insulin rapidly. Participants will receive a standardized liquid meal containing whey protein, maltodextrin, and sunflower oil. During the study visits, sweat and blood samples will be collected over several hours, using a device on the forearm to gather sweat and a microneedle patch to sample fluids beneath the skin. These samples will help compare insulin levels across different body fluids. Participants will visit the research center after fasting and undergo various health assessments, including body composition scans, walking tests, and muscle function evaluations. Blood samples will be drawn via a catheter, and sweat and skin fluid will be collected while participants rest for up to nine hours. Questionnaires about health and well-being will also be completed. The main goal is to measure insulin and related proteins over time to understand how well the wearable sensor works and how sweat insulin relates to blood insulin levels.

Researchers are studying how the body absorbs and responds to a reformulated Levulan Kerastick drug applied to actinic keratosis AK lesions on the forearms or face, followed by photodynamic therapy PDT using blue light. This phase 1 pharmacokinetic study aims to measure blood levels of the active ingredient aminolaevulinic acid and its by-product protoporphyrin IX to understand drug behavior during treatment. Participants will be assigned to one of two groups based on lesion location cohort A with treatment on both forearms covered during a 3-hour incubation, or cohort B with treatment on the face without covering during incubation. After incubation, an 8-minute and 20-second light therapy is applied. Serial blood samples are collected at multiple timepoints up to 48 hours after dosing to measure drug levels. During the study, participants will have blood drawn frequently on day 1 through day 3 to monitor pharmacokinetics. Researchers will assess plasma drug concentrations and evaluate safety and tolerability through day 29. The total participation lasts from treatment initiation through follow-up assessments, ensuring close monitoring of drug absorption and participant health.

Researchers are studying the anabolic response to beef versus plant protein in older adults aged 65 to 95 years, including those who are frail, pre-frail, or non-frail. The study aims to understand how different protein sources affect protein and amino acid synthesis in the body, especially considering that older adults may have higher protein needs and a reduced anabolic response to meals. This research is important because many older adults choose to avoid animal products like beef, which has high levels of essential amino acids and anabolic benefits. Participants will consume three types of nutrition in a randomized, cross-over design beef protein, tofu soy protein, and water as a placebo. The feeding is given in small bites and sips every 20 minutes over a 5-hour period during study visits. The study includes one screening visit and four study days, where various assessments like body composition, muscle function, and walk tests are performed. Some procedures may be skipped if recently completed. During visits, participants will be fasted and have vital signs and blood samples taken before and during feeding. Researchers will measure anabolic responses using stable isotope tracers and assess amino acid bioavailability. The primary outcome is the capacity for protein and amino acid synthesis after consuming beef and soy protein. The total time commitment includes the initial screening and study days, with data securely stored for analysis.

Researchers are evaluating the effects of SageXtra, a sage extract supplement, on cognitive function and reaction times in middle-aged adults aged 40 to 60. Sage is known for its antioxidant, anti-inflammatory, and neuroprotective properties, and some studies suggest it may improve cognitive abilities however, more research is needed to confirm these benefits. Participants will receive either 333 mg of SageXtra or a placebo daily, administered as two capsules each day, for 8 consecutive weeks. The study uses a randomized, parallel design with quadruple masking to compare the supplement against placebo. The primary focus is on cognitive performance, measured by a computerized test battery at 4 and 8 weeks. During the study, participants will undergo assessments of cognitive and physical performance. Researchers will monitor adherence to the study protocol and collect data on mental performance using the COMPASS test at specified intervals. The study includes healthy volunteers with specific BMI and lifestyle requirements, and participation will last for at least 8 weeks with evaluations at multiple time points.

Researchers are studying how different macronutrient intakes affect levels of small molecule markers in blood and interstitial fluid. The study aims to validate wearable optical readers and data fusion algorithms that can predict individual-specific macronutrient availability in real time. This trial focuses on healthy adults aged 50 to 75 years, investigating glucose and amino acid metabolism. Participants will attend one screening visit lasting about 2 hours and up to four study days of approximately 14 hours each. On study days, they consume two predefined meals with specific macronutrient compositions six to eight hours apart. Blood samples are taken via an in-dwelling catheter with the arm heated to collect arterialized venous blood. Microdialysis catheters collect samples from the opposite arm to analyze metabolism markers. During the study, body weight, height, and body composition are measured. Participants complete questionnaires on dietary habits, physical activity, and quality of life. Blood and dialysate samples are processed and stored for later analysis of amino acids, fatty acids, glucose, and insulin. The primary outcome is glucose metabolism measured over up to 14 hours per visit, with secondary outcomes including amino acid metabolism. Participants safety and adherence are monitored throughout the study which ends in December 2026.

Researchers are evaluating whether a personalized food kit for pregnant women can improve their diet quality and pregnancy outcomes compared to standard prenatal care. This trial focuses on pregnant individuals with singleton pregnancies between 7 and 12 weeks of gestation, aiming to understand if these food kits are practical to use and helpful during pregnancy and after birth. Participants are randomly assigned to one of two groups one group receives personalized food kits every two weeks from the first trimester until 6 weeks postpartum, with 2-3 kits provided after birth. They can choose their food kit contents within set categories and amounts. The control group receives usual prenatal care without the food kits, and all participants verify that they are receiving or plan to receive standard prenatal care, which is not provided by the study. Throughout the study, participants attend regular visits for clinical data collection and complete questionnaires about their diet and health. Researchers will measure diet quality using the Healthy Eating Index from baseline to 6 weeks postpartum. They will also monitor blood markers like Hemoglobin A1C and C-Reactive Protein, track gestational weight gain, and assess postpartum weight retention. The study includes follow-ups around 12 weeks postpartum, with a total participation period covering pregnancy and the early postpartum phase.

Researchers are evaluating a new combined cognitive-behavioral therapy for adults with both posttraumatic stress disorder PTSD and alcohol use disorder AUD. This study compares the effectiveness of an integrated treatment combining Cognitive Processing Therapy CPT with Relapse Prevention RP against RP alone. The goal is to see if the combined approach better reduces alcohol use and PTSD symptoms, using standardized clinical measures and daily monitoring of behavior and symptoms. Participants receive either 12 individual sessions of CPT plus RP or 12 sessions of RP alone, each session lasting 90 minutes and delivered twice weekly. Flexibility is allowed to complete sessions within nine weeks. The CPTRP treatment addresses the links between PTSD and alcohol use by teaching coping strategies for cravings, managing triggers, and restructuring trauma-related thoughts. The RP-only sessions focus on coping skills related to alcohol use, such as managing cravings and planning for emergencies. During the study, participants will be assessed regularly using clinical scales like the Timeline Follow-Back for alcohol use and the Clinician Administered PTSD Scale. Daily real-time data on alcohol-related thoughts and PTSD symptoms will be collected through ecological momentary assessment. Outcomes will be measured through treatment completion and at follow-up points up to 12 months later. The study includes safety monitoring and adherence tracking, with overall participation lasting at least 12 weeks for treatment and additional follow-up periods.

Researchers are studying the effects of lutein, zeaxanthin, and fish oil LZF supplements on healthy adults aged 18 to 45 who have low macular pigment optical density MPOD. The trial aims to find out if taking LZF for six months can improve MPOD, cognitive performance, and bone density compared to a placebo. The study uses a precision nutrition model to address risks related to aging, including macular degeneration, cognitive decline, and bone loss. Participants will be randomly assigned to take either a daily LZF supplement containing 7 mg lutein, 14 mg zeaxanthin, and 245 mg fish oil or a placebo supplement. This treatment lasts for six months. The study is double-blind and controlled, meaning neither participants nor researchers know who receives the supplement or placebo. During the trial, participants will undergo assessments at the start, three months, and six months. These include measuring MPOD, cognitive performance using Neurotracker software, bone density via DXA scans, fasting blood samples, and serum levels of lutein and zeaxanthin. Researchers will track changes over time to understand the impact of the supplements on vision, thinking skills, and bone health.

Researchers are investigating the metabolic changes and functional consequences associated with aging in adults aged 50 and older. The study aims to understand how aging affects physical and cognitive functions, as well as overall well-being, by examining the metabolic profiles linked to disorders that may impair these abilities. This observational study focuses on the variability in aging experiences, including healthy longevity and age-related decline, to better understand pathways that contribute to aging-related disorders. Participants will undergo a series of assessments including stable tracer infusions that track amino acid and other metabolic pathways in the body. The study involves a screening visit to measure body weight, composition by DXA scan, height, and vital signs. On study days, participants may receive combinations of stable tracer infusions with blood draws, alongside cognitive and muscle performance testing to evaluate metabolic and functional changes. During the study, participants will be evaluated on whole-body metabolism including protein, amino acid, glucose, and fat metabolism. Additional assessments include mood, depression, anxiety, physical activity, sleep quality, nutrition, cognitive abilities, muscle strength, balance, respiratory strength, and gut health. Outcome measures focus on age-related changes across these domains, with data collected at baseline and during metabolic testing sessions lasting approximately two hours. Participants health and safety will be monitored throughout the study duration, which is expected to continue until September 2026.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.