College Station

Researchers are exploring a wearable technology to noninvasively monitor insulin levels through sweat, aiming to improve precision nutrition and support healthy living. Insulin plays a key role in regulating blood sugar and energy, and its imbalance is linked to conditions like diabetes, obesity, and metabolic syndrome. Current noninvasive methods lack sensitivity and timely measurement, so this study focuses on developing a device that can provide rapid, real-time insulin quantification outside of clinical settings. The study will test a wearable device that stimulates sweat production and measures insulin concentration directly from sweat, dermal interstitial fluid, and blood. Participants will have sensors applied to their forearm, including a microneedle patch to sample dermal fluid, while sweat is collected via electrodes. After two hours of baseline sample collection, participants will consume a standardized liquid meal containing whey protein, maltodextrin, and sunflower oil. Biological samples will continue to be collected for five more hours to monitor insulin changes. Participants will visit the research center fasting, undergo body composition scans, muscle function tests, and complete health questionnaires. During the study day, vital signs, blood samples, sweat, and dermal fluid will be collected over several hours while the participant remains mostly lying down. Researchers will analyze protein biomarkers up to nine hours to validate the device's insulin measurement accuracy and correlation across different biofluids. The study expects to improve understanding of insulin dynamics with a wearable sensor over a full day of monitoring.

Frailty is a common condition in older adults that raises the risk of falls, disability, hospitalization, and death. This research investigates how older adults with and without pre-frailty respond to different protein sources, specifically comparing beef protein to plant-based protein like soy tofu. The study aims to understand differences in the body's ability to use essential and non-essential amino acids from these proteins using a new stable isotope pulse method. Participants will attend a screening visit and four study days at the Center for Translational Research on Aging and Longevity at Texas A&M University. The study uses a randomized crossover design where participants consume beef, tofu, or water as a placebo in separate visits. Nutrition is given in small bites and sips every 20 minutes over 5 hours, combined with tracer compounds administered intravenously to measure the anabolic response and amino acid bioavailability. During the study, participants will undergo body composition scans, muscle function tests, questionnaires, and blood sampling before and after feeding sessions. The research measures protein and amino acid synthesis capacity over six weeks. Participants will be asked to arrive fasting on study days, and all data will be securely recorded. The total participation involves about one screening visit lasting 3 hours and four study visits with multiple assessments to monitor health and protein metabolism.

Researchers are studying the relationship between the intake of macronutrients (carbohydrates, proteins, fats) and the levels of small molecule markers in blood and interstitial fluid. The study aims to validate wearable optical devices and data algorithms that can predict an individual's macronutrient availability in real time. This research focuses on adults aged 50 to 75 years with specific body mass index ranges and examines glucose and amino acid metabolism. Participants will attend one screening visit lasting about 2 hours and up to four study days, each approximately 14 hours long. On study days, participants will consume meals with defined macronutrient compositions twice daily, eight hours apart. Blood samples will be collected through a catheter in the arm, with the arm placed in a heated box to obtain arterialized venous blood. A microdialysis catheter will be placed in the opposite arm to collect dialysate samples continuously. Various blood and dialysate analyses will be performed to measure amino acids, fatty acids, glucose, and insulin. Throughout the study, participants will undergo body weight and height measurements, body composition scans, and assessments of dietary habits, physical activity, and quality of life. Researchers will monitor glucose metabolism up to 14 hours per study visit across up to four visits. Samples will be stored and analyzed for various metabolic markers. The entire participation involves careful monitoring, sample collection, and compliance with study protocols to ensure safety and accurate data collection.

Researchers are evaluating a new integrative cognitive-behavioral therapy combining Cognitive Processing Therapy (CPT) for posttraumatic stress disorder (PTSD) and Relapse Prevention (RP) for alcohol use disorder (AUD). This study focuses on adults with co-occurring moderate to severe AUD and PTSD, aiming to compare the effectiveness of CPT-RP versus RP alone in reducing alcohol use and PTSD symptoms. The study addresses the need for trauma-focused, integrated treatments and builds on preliminary data demonstrating safety, feasibility, and high patient satisfaction. Participants will receive either the combined CPT-RP therapy or RP alone, both cognitive-behavioral approaches delivered as manualized interventions. The study employs a randomized design and uses standardized assessments at multiple time points over an average of 12 weeks of treatment. CPT-RP integrates trauma-focused therapy with relapse prevention strategies, while RP focuses specifically on alcohol use reduction. The trial also includes daily monitoring of alcohol-related thoughts and behaviors using ecological momentary assessment to understand treatment effects in real time. Throughout the study, participants will undergo repeated clinical outcome measurements including alcohol use frequency and quantity via Timeline Follow-Back and PTSD symptom severity via the Clinician Administered PTSD Scale. Daily assessments will track associations between PTSD symptoms, distress tolerance, and alcohol-related behaviors. Researchers will monitor retention, safety, and treatment adherence, with the overall goal of improving behavioral treatments for individuals with AUD and PTSD over approximately 12 weeks of active treatment.

This research aims to understand how supplements containing lutein, zeaxanthin, and fish oil (LZF) affect healthy adults aged 18 to 45 years, particularly those with lower levels of macular pigment optical density (MPOD less than 0.43). The study focuses on whether these supplements can improve eye health, cognitive abilities, and bone strength over six months. It also seeks to develop a personalized nutrition approach to reduce risks related to macular degeneration, cognitive decline, and bone loss by using non-invasive screening methods. Participants will be randomly assigned to take either the LZF supplement, which includes 7 mg lutein, 14 mg zeaxanthin, and 245 mg fish oil daily, or a placebo for six months. This trial is double-blind, meaning neither the participants nor the researchers know who receives the supplement or placebo until the study ends. The main comparison will assess changes in MPOD, cognitive performance, and bone health between the two groups. During the study, participants will undergo various assessments including fasting blood draws, measurements of MPOD, bone density scans using DXA technology, and tests of visual cognitive performance using Neurotracker software. These evaluations will occur at the start and end of the six-month period. Researchers will monitor MPOD at baseline, three months, and six months, while cognitive tests will be done at baseline, three months, and six months. Bone density will be measured at baseline and at the study's conclusion to assess any changes.

Researchers are investigating how aging affects whole-body protein and amino acid metabolism and how these metabolic changes relate to physical and cognitive decline in older adults. The study aims to understand the differences in aging trajectories among individuals, including those who experience healthy aging versus those with impaired functional capacity and well-being. By exploring metabolic profiles associated with aging-related disorders, the research may identify potential therapeutic targets. Participants will undergo an infusion of multiple stable-labeled tracers of amino acids, ketoacids, glycerol, and short-chain fatty acids while in a postabsorptive state. This approach allows simultaneous study of multiple metabolic pathways related to protein turnover. The study focuses on measuring how aging impacts protein synthesis and breakdown, contributing to changes in physical function. During the study, participants' whole-body metabolism will be measured over a two-hour period to assess age-related changes. Researchers will evaluate functional capacity, cognitive function, and overall well-being, combined with laboratory tests and medical history reviews. The study includes assessments of walking and mobility abilities and requires participants to lie down for up to three hours. Safety and compliance will be monitored throughout the process.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are investigating how aging affects protein and amino acid metabolism in older adults. The study aims to understand changes in metabolism that could contribute to reduced physical function as people age. By using a specialized method involving stable isotopes, the researchers hope to reveal differences in metabolic pathways related to aging, especially focusing on amino acids linked to age-related disorders. Participants will take part in one screening visit lasting about 3 hours and six study days, each about 8 hours long. During the study days, participants will arrive fasting and receive one of six liquid nutritional supplements every 20 minutes for 6 hours. These supplements vary in their amino acid content, including total amino acids, essential amino acids, essential amino acids combined with hydroxy-methylbutyric acid (HMB), leucine, a high dose of essential amino acids, or a placebo of water. Blood samples will be collected before feeding and during the feeding period to measure metabolic changes. Throughout the study, participants will undergo measurements of body weight, height, and body composition by DXA, as well as functional tests like the Six-Minute Walk Test and muscle function assessments. Vital signs and blood samples will be taken regularly to monitor metabolism and safety. The primary outcome measured is the change in whole-body protein and amino acid metabolism during feeding, observed for up to 6 hours. The study includes careful health evaluations and requires participants to comply with study procedures over multiple visits.

Researchers are studying how plant-based and animal-based proteins affect muscle-building responses in older adults, including those with sarcopenia, a condition involving muscle loss. The study focuses on the differences in essential and non-essential amino acids produced after meals, with the goal of identifying protein compositions that best support muscle health. This work aims to guide new nutrition strategies to help prevent and treat sarcopenia, improving patient outcomes and reducing healthcare costs. Participants will consume liquid nutritional supplements containing one of four options: 45 grams of whey protein (animal-based), 45 grams of soy protein (plant-based), 45 grams of pea protein (plant-based), or a placebo of water. These sip feeds are given every 20 minutes over a 5-hour period. The study uses a sip feeding model to assess the body's anabolic (muscle-building) response and involves intravenous tracers to measure amino acid metabolism. Participants may also choose to add sugar-free flavor syrups to their drinks. The study includes one screening visit lasting about 3 hours and four separate study days. Screening involves measurements like body composition, muscle function tests, and a six-minute walk test. During study visits, vital signs and blood samples are taken before and after feeding to track protein metabolism. Researchers will measure the protein and amino acid synthesis capacity over four weeks using stable isotope tracers. Data are securely stored, and participants are asked to arrive fasting for study days, though fasting before screening is not required.

Researchers are evaluating the safety and effectiveness of VDPHL01, an oral investigational drug, in treating female patients with Androgenetic Alopecia (AGA), a genetic condition causing hair loss due to an excessive hair follicle response to hormones. This Phase 3, multi-center, double-blind study involves adult women aged 18 to 65 with mild to moderate AGA. The study aims to assess changes in hair counts and participants' evaluation of treatment benefit after 6 months. Participants will be randomly assigned to receive either VDPHL01 extended release tablets once daily or twice daily, or a placebo tablet. The study includes 11 visits over approximately 13 months: screening, baseline (day 1), weeks 2, months 1, 2, 4, 6, 8, 10, 12, and a final visit at month 13. During the study, participants must maintain consistent hair length, style, and color, and agree to have a micro dot tattoo placed on the scalp for photography and assessment. Throughout the trial, researchers will monitor hair growth through non-vellus target area hair counts and collect participants' feedback on treatment benefits at 6 months. The study involves multiple assessments including photography of the scalp, questionnaires, and general health evaluations. Safety and efficacy data will be collected until the final visit at month 13.