Engineering Papers⌕ Search

SEARCH · Engineering Papers

Results for “evaluation protocols”

Search indexed NASA NTRS and DOE OSTI research on propulsion, heat transfer, battery materials and energy systems. Follow report and document links to the original sources.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 163 records · Page 9
All sourcesNASA NTRSDOE OSTI
DOE OSTI2024

Evaluating Radiation Impact on Transmon Qubits Using a Fast Decay Protocol in Above and Underground Laboratories

Superconducting qubits can be sensitive to sudden energy deposits caused by ambient radioactivity and cosmic rays. Previous studies have focused on understanding possible correlated effects over time and distance due to this radiation. In this study‚ for the first time‚ we directly compare the response of a transmon qubit measured initially at the SQMS above-ground facility (Fermilab‚ Illinois‚ USA) and then at the deep underground Gran Sasso Laboratory (INFN-LNGS‚ Italy). We observe the same average qubit lifetime of roughly 80 microseconds at both facilities. We then apply a fast decay detection protocol and investigate the time structure and relative rates of triggered events due to radiation versus intrinsic noise‚ comparing the above and underground performance of several high-coherence qubits. Using gamma sources of variable intensity we calibrate the response of the qubit to different levels of radiation in an environment with minimal background radiation. Results indicate that qubits respond to a strong gamma source‚ and it is possible to detect particle impacts. However‚ we do not observe a difference in radiation-induced-like events when comparing the above and underground results for niobium-based transmon qubits with sapphire substrates. We conclude that the majority of these events are not radiation-related and are attributed to other noise sources‚ which by far dominate single-qubit errors in modern transmon qubits. [1] Dominicis‚ Roy et al. arXiv:2405.18355

Roy, Tanay↗
DOE OSTI2025

Evaluation of DNA Extraction Efficiency in Diverse Algae Strains Using Commercial Kits and Lysis Approaches

Efficient DNA extraction is essential for accurately monitoring microalgae communities in large-scale cultivation systems such as raceway ponds and wastewater ponds. Traditional phenol chloroform extracts are a staple in microbiology but are obsolete for routine sampling due to its high toxicity reagents and time intensive setups. Commercial DNA extraction kits are more favorable for the microbes found in these ponds, but lack specific kits made for these communities. Little is known about which kits perform the best, leading researchers to use a variety of different kits with inconsistent results. This project compared one precipitation based commercial kit (Lucigen Masterpure) and five wash based kits (Monarch, Zymo Quick-DNA, and three Qiagen DNeasy kits) using four brackish algae strains to determine which methods yield the greatest quantity and quality of genomic DNA. Extractions were evaluated using the manufacturers protocol, and additional pretreatment options were administered before a single kit to compare its potential in being added routinely before extractions. Pretreatment options included both cryogenic freeze-thawing and heat incubation using enzymes. DNA was quantified using Qubit fluorometry and NanoDrop purity ratios. Overall, the Qiagen PowerWater kit provided the highest DNA yield and purity, but at a significantly higher cost then the precipitation-based kit (MasterPure). It was also noted that while the precipitation-based kit was significantly cheaper, provided similar results, it took significantly more time to complete a single run. Cryogenic pretreatment (6x cycles) increased average DNA yields by up to 80%, whereas enzymatic pretreatment most improved purity ratios without substantially improving quantity. The results suggest that it may be more cost and time efficient to use Qiagen kits with the addition of lysis pretreatments to procure better results. Future works includes developing a better system to efficiently collect multi variable data, and to upscale to artificial polycultures using similar methodologies alongside sequencing to confirm kit results.

59 BASIC BIOLOGICAL SCIENCES↗
NASA NTRS1985

Standardization of ground and flight data interfaces for spaceflight instrument support

Instrument Ground Support Equipment (IGSE) will be used for instrument support on both the ground and flight phases of the Gamma-Ray Observatory (GRO) program. These mission phases include instrument development, observatory integration and test, prelaunch processing at the Kennedy Space Center (KSC) end-to-end testing, and in-orbit operations. The data interfaces between each of the IGSE's and the ground and flight systems have been evaluated to determine whether they should be standardized, and, if so, to what standard and why? Standardization, in this concept, provides for the capability to use the same IGSE without change as these systems are used throughout the various phases of the mission listed above. This evaluation has shown that there is a cost savings associated with standardization. In addition, several other intrinsic benefits have been identified. Based on this evaluation, the international standard protocol X.25 was selected to interface each of the IGSE's to the ground and flight systems.

Felice, R.↗
NASA NTRS1993

Zeolite crystal growth in space - What has been learned

Three zeolite crystal growth experiments developed at WPI have been performed in space in last twelve months. One experiment, GAS-1, illustrated that to grow large, crystallographically uniform crystals in space, the precursor solutions should be mixed in microgravity. Another experiment evaluated the optimum mixing protocol for solutions that chemically interact ('gel') on contact. These results were utilized in setting the protocol for mixing nineteen zeolite solutions that were then processed and yielded zeolites A, X and mordenite. All solutions in which the nucleation event was influenced produced larger, more 'uniform' crystals than did identical solutions processed on earth.

Sacco, A., Jr.↗
NASA NTRS2018

Preparation for Pick-and-Eat Food Production on the International Space Station: Flight Definition for the VEG-04 and VEG-05 Missions

Growth of fresh, nutritious, palatable produce for crew consumption during spaceflight may provide health-promoting, bioavailable nutrients and enhance the dietary experience as we move toward longer-duration missions. Tending plants also may serve as a countermeasure for crew psychological stresses associated with long duration spaceflight. However, requirements to support consistent growth of a variety of high quality, nutritious crops under spaceflight environmental conditions is unknown. This study is exploring the potential to grow plants for food production on the International Space Station (ISS) using the Veggie vegetable production system. Ground testing is underway to compare the impacts of several fertilizer and lighting treatments on growth, quality, and nutritional composition of the leafy green crop mizuna, and the dwarf tomato crop Red Robin when subjected to Veggie ISS environmental conditions. Early testing focused on the leafy crop Tokyo Bekana Chinese cabbage, but ground tests indicated that this plant suffered from stress responses when grown under LEDs and the chronically elevated CO2 levels found on the ISS. Mizuna, a related leafy variety that grows well in the presence of high CO2, and has excellent organoleptic characteristics, was selected as an alternate crop. Tomato crops have been grown using two fertilizer formulations and two pollination techniques, and growth tests using different red:blue lighting environments are underway. Chemical analysis is also being conducted and these data, when coupled with the growth results, will be used to down-select to the two best lighting treatments and best fertilizer treatment for future testing of each crop on the ISS. Additionally, seed-source testing has become important, with mizuna seeds from two different vendors growing very differently. A seed source has been selected, and seed-surface-sanitizing methods have been confirmed for mizuna, but these remain under development for tomato. A crop-handling protocol is also being evaluated to support food safety. All harvests reserve a subset of samples for microbial analysis to determine baseline microbial levels and help establish critical control points for food safety. Testing was initially conducted in hardware analogs of the standard Veggie plant pillows. However, a new Veggie watering system, the Passive Orbital Nutrient Delivery System or PONDS, has been designed and is being prepared for future flight experiments. With the selection of this growth system, ground tests have shifted to analog PONDS systems. Crop tests on ISS, designated VEG-04 for mizuna and VEG-05 for tomato, are planned in 2018 to evaluate any additional impacts of spaceflight on the light and fertilizer conditions down-selected from ground tests. A set of Veggie-specific questions has been developed to characterize the psychological impacts of plant growth and plant-care activities during spaceflight. Organoleptic questionnaires have been developed to assess produce attributes in microgravity taste sessions. These tests for plants growing in the Veggie hardware on ISS will help to mitigate the risk of an inadequate food supply for long duration missions by developing methods and determining hardware requirements to integrate fresh vegetables as a dietary supplement. This research was co-funded by the Human Research Program and Space Biology (MTL1075) in the ILSRA 2015 NRA call.

Veggie↗
NASA NTRS2018

Preparation for Pick-and-Eat Food Production on the International Space Station: Flight Definition for the VEG-04 and VEG-05 Missions

Growth of fresh, nutritious, palatable produce for crew consumption during spaceflight may provide health-promoting, bioavailable nutrients and enhance the dietary experience as we move toward longer-duration missions. Tending plants also may serve as a countermeasure for crew psychological stresses associated with long duration spaceflight. However, requirements to support consistent growth of a variety of high quality, nutritious crops under spaceflight environmental conditions is unknown. This study is exploring the potential to grow plants for food production on the International Space Station (ISS) using the Veggie vegetable production system. Ground testing is underway to compare the impacts of several fertilizer and lighting treatments on growth, quality, and nutritional composition of the leafy green crop mizuna, and the dwarf tomato crop "Red Robin" when subjected to Veggie ISS environmental conditions. Early testing focused on the leafy crop "Tokyo Bekana" Chinese cabbage, but ground tests indicated that this plant suffered from stress responses when grown under LEDs and the chronically elevated CO2 levels found on the ISS. Mizuna, a related leafy variety that grows well in the presence of high CO2, and has excellent organoleptic characteristics, was selected as an alternate crop. Tomato crops have been grown using two fertilizer formulations and two pollination techniques, and growth tests using different red:blue lighting environments are underway. Chemical analysis is also being conducted and these data, when coupled with the growth results, will be used to down-select to the two best lighting treatments and best fertilizer treatment for future testing of each crop on the ISS. Additionally, seed-source testing has become important, with mizuna seeds from two different vendors growing very differently. A seed source has been selected, and seed-surface-sanitizing methods have been confirmed for mizuna, but these remain under development for tomato. A crop-handling protocol is also being evaluated to support food safety. All harvests reserve a subset of samples for microbial analysis to determine baseline microbial levels and help establish critical control points for food safety. Testing was initially conducted in hardware analogs of the standard Veggie plant pillows. However, a new Veggie watering system, the Passive Orbital Nutrient Delivery System or PONDS, has been designed and is being prepared for future flight experiments. With the selection of this growth system, ground tests have shifted to analog PONDS systems. Crop tests on ISS, designated VEG-04 for mizuna and VEG-05 for tomato, are planned in 2018 to evaluate any additional impacts of spaceflight on the light and fertilizer conditions down-selected from ground tests. A set of Veggie-specific questions has been developed to characterize the psychological impacts of plant growth and plant-care activities during spaceflight. Organoleptic questionnaires have been developed to assess produce attributes in microgravity taste sessions. These tests for plants growing in the Veggie hardware on ISS will help to mitigate the risk of an inadequate food supply for long duration missions by developing methods and determining hardware requirements to integrate fresh vegetables as a dietary supplement. This research was co-funded by the Human Research Program and Space Biology (MTL#1075) in the ILSRA 2015 NRA call.

LED light↗
NASA NTRSDate not supplied

Rational Design of Nanoplasmonic Array Geometries for Biosensing

Background: Molecular diagnostics provide early and accurate diagnosis, which is essential for the prevention and treatment of infectious as well as chronic diseases. These tests are designed to detect disease-specific bioanalytes such as nucleic acid (DNA or RNA) or protein (antigens, antibodies) biomarkers. In the context of infectious disease diagnosis, nucleic acid-based detection methods are known to provide more specific and sensitive results. Here, the presence of a unique sequence belonging to the pathogenic genomic material is targeted to identify species, organism, genera and/or antimicrobial resistant gene markers. The majority of the common nucleic acid based diagnostic techniques require amplification (polymerase chain reaction, isothermal amplification etc.) of the pathogenic genetic material prior to detection impacting diagnostic speed, complexity, and cost thereby limiting ease of use. Thus, the development of simplified nucleic acid-based diagnostics that can be even used in resource-poor settings may hugely benefit patients across the globe. Nanopath is a molecular diagnostics company utilizing a solid-state nanosensor to enable sequence-specific detection of target nucleic acids without the need of amplification. These nanostructures enable ultra-sensitive biomarker detection using geometric, feature-dependent properties highly dependent on the local dielectric environment, allowing them to be sensitive to low concentration binding events. This paper describes an application of this approach to provide highly relevant clinical information within a single doctor’s office visit. Intro: The Nanopath team is in collaboration with NASA (National Aeronautics and Space Administration) and NIST (National Institute of Standards and Technology) to push the bounds of the fundamental physics associated with their biosensing platform. The ability of metals to support electromagnetic surface waves gives rise to surface plasmons when optically illuminated. This property, and its strong sensitivity to changes in the local refractive index, allows for the use of metal nanoparticles as ultra-sensitive transducers. In prior work by members of this team, ensembles of randomly oriented nanoparticles (i.e., colloidal nanorods dispersed on chip) were employed for sequence-specific nucleic acid sensing (1-3). While these particle sensors have the advantage of rapid fabrication, they suffer from low sensitivity and quality factor due to the random particle dispersity. In contrast, in this study we employ ordered array nanoparticle ensembles which can be used to improve sensor sensitivity and figure-of-merit. Study Methods Overview: In this talk, we detail the results of sensing experiments and computational simulations to outline a rational design of the structure of these plasmonic nanoparticle arrays for biomolecular sensing. Through simulation and experiment, we iteratively tailor nanostructure dimension to provide high quality signal and large resonance shifts upon modeled nucleic acid binding. In particular, full-wave electromagnetic simulations were conducted using Lumerical photonic simulation software in which periodic boundary conditions were applied in the x- and y- dimensions for each of the nanoplasmonic sensor geometries. To simulate the resonance response to changes in the bulk solution in contact with the sensor surface, the refractive index of the surrounding media was changed appropriately. Nucleic acid hybridization events were modeled using either using spherical structures approximating the relevant radius of genomic material as estimated by polymer models, or as conformal layers with the known refractive indices for nucleic acids. On the basis of initial simulations, nanosensors were fabricated using traditional electron-beam lithography protocols at NIST. To evaluate consensus between simulations and experiments, bulk sensing experiments were carried out in which the resonance peaks were obtained by submerging the sensors in refractive index standards. Key nanosensor characteristics including resonance peak locations, resonance peak shifts as a function of refractive index, and figure of merit (FOM) of extinction curves were examined between the experimental and simulation results prior to proceeding with simulations on additional geometries and more complex solution conditions, and further device fabrication. This iterative process is repeated toward a rational design of nanoplasmonic array geometries for biosensing optimizing response for targeted disease detection. In summary, this study puts forth a methodology for rational design and characterization of regularly spaced nanoparticle arrays for optics-based biosensing. The results of this study will allow for more informed design of nanostructure geometries towards sequence-specific nucleic acid detection. These improved designs have the potential to improve clinical sensitivity and limit-of-detection across disease indication.

sensor↗
NASA NTRS2018

Development of a Ground Test and Analysis Protocol for NASA's NextSTEP Phase 2 Habitation Concepts

The NASA Next Space Technologies for Exploration Partnerships (NextSTEP) program is a public-private partnership model that seeks commercial development of deep space exploration capabilities to support human spaceflight missions around and beyond cislunar space. NASA first issued the Phase 1 NextSTEP Broad Agency Announcement to U.S. industries in 2014, which called for innovative cislunar habitation concepts that leveraged commercialization plans for low-Earth orbit. These habitats will be part of the Deep Space Gateway (DSG), the cislunar space station planned by NASA for construction in the 2020s. In 2016, Phase 2 of the NextSTEP program selected five commercial partners to develop ground prototypes. A team of NASA research engineers and subject matter experts (SMEs) have been tasked with developing the ground-test protocol that will serve as the primary means by which these Phase 2 prototypes will be evaluated. Since 2008, this core test team has successfully conducted multiple spaceflight analog mission evaluations utilizing a consistent set of operational tools, methods, and metrics to enable the iterative development, testing, analysis, and validation of evolving exploration architectures, operations concepts, and vehicle designs. The purpose of implementing a similar evaluation process for the Phase 2 Habitation Concepts is to consistently evaluate different commercial partner ground prototypes to provide data-driven, actionable recommendations for Phase 3. This paper describes the process by which the ground test protocol was developed and the objectives, methods, and metrics by which the NextSTEP Phase 2 Habitation Concepts will be rigorously and systematically evaluated. The protocol has been developed using both a top-down and bottom-up approach. Top-down development began with the Human Exploration and Operations Mission Directorate (HEOMD) exploration objectives and ISS Exploration Capability Study Team (IECST) candidate flight objectives. Strategic questions and associated rationales, derived from these candidate architectural objectives, provide the framework by which the ground-test protocol will address the DSG stack elements and configurations, systems and subsystems, and habitation, science, and EVA functions. From these strategic questions, high-level functional requirements for the DSG were drafted and associated ground-test objectives and analysis protocols were established. Bottom-up development incorporated objectives from NASA SMEs in autonomy, avionics and software, communication, environmental control and life support systems, exercise, extravehicular activity, exploration medical operations, guidance navigation and control, human factors and behavioral performance, human factors and habitability, logistics, Mission Control Center operations, power, radiation, robotics, safety and mission assurance, science, simulation, structures, thermal, trash management, and vehicle health. Top-down and bottom-up objectives were integrated to form overall functional requirements - ground-test objectives and analysis mapping. From this mapping, ground-test objectives were organized into those that will be evaluated through inspection, demonstration, analysis, subsystem standalone testing, and human-in-the-loop (HITL) testing. For the HITL tests, mission-like timelines, procedures, and flight rules have been developed to directly meet ground test objectives and evaluate specific functional requirements. Data collected from these assessments will be analyzed to determine the acceptability of habitation element configurations and the combinations of capabilities that will result in the best habitation platform to be recommended by the test team for Phase 3.

Gernhardt, Michael L.↗
NASA NTRS2014

The Effect of Growth Environment and Salinity on Lipid Production and Composition of Salicornia virginica

Finding a viable and sustainable source of renewable energy is a global task. Biofuels as a renewable energy source can potentially be a viable option for sustaining long-term energy needs. Biodiesel from halophytes shows great promise due to their ability to serve not only as a fuel source, but a food source as well. Halophytes are one of the few biomass plant species that can tolerate a wide range of saline conditions. We investigate the feasibility of using the halophyte, Salicornia virginica as a biofuel source by conducting a series of experiments utilizing various growth and salinity conditions. The goal is to determine if the saline content of Salicornia virginica in our indoor growth vs outdoor growth conditions has an influence on lipid recovery and total biomass composition. We focused on using standard lipid extraction protocols and characterization methods to evaluate twelve Salicornia virginica samples under six saline values ranging from freshwater to seawater and two growth conditions. The overall goal is to develop an optimal lipid extraction protocol for Salicornia virginica and potentially apply this protocol to halophytes in general.

Bomani, Bilal Mark McDowell↗
NASA NTRS2003

Using Simulations to Investigate Decision Making in Airline Operations

This paper examines a range of methods to collect data for the investigation of decision-making in airline Operations Control Centres (OCCs). A study was conducted of 52 controllers in five OCCs of both domestic and international airlines in the Asia-Pacific region. A range of methods was used including: surveys, interviews, observations, simulations, and think-aloud protocol. The paper compares and evaluates the suitability of these techniques for gathering data and provides recommendations on the application of simulations. Keywords Data Collection, Decision-Making, Research Methods, Simulation, Think-Aloud Protocol.

Bruce, Peter J.↗
NASA NTRS1998

High End Computer Network Testbedding at NASA Goddard Space Flight Center

The Earth & Space Data Computing (ESDC) Division, at the Goddard Space Flight Center, is involved in development and demonstrating various high end computer networking capabilities. The ESDC has several high end super computers. These are used to run: (1) computer simulation of the climate systems; (2) to support the Earth and Space Sciences (ESS) project; (3) to support the Grand Challenge (GC) Science, which is aimed at understanding the turbulent convection and dynamos in stars. GC research occurs in many sites throughout the country, and this research is enabled by, in part, the multiple high performance network interconnections. The application drivers for High End Computer Networking use distributed supercomputing to support virtual reality applications, such as TerraVision, (i.e., three dimensional browser of remotely accessed data), and Cave Automatic Virtual Environments (CAVE). Workstations can access and display data from multiple CAVE's with video servers, which allows for group/project collaborations using a combination of video, data, voice and shared white boarding. The ESDC is also developing and demonstrating the high degree of interoperability between satellite and terrestrial-based networks. To this end, the ESDC is conducting research and evaluations of new computer networking protocols and related technologies which improve the interoperability of satellite and terrestrial networks. The ESDC is also involved in the Security Proof of Concept Keystone (SPOCK) program sponsored by National Security Agency (NSA). The SPOCK activity provides a forum for government users and security technology providers to share information on security requirements, emerging technologies and new product developments. Also, the ESDC is involved in the Trans-Pacific Digital Library Experiment, which aims to demonstrate and evaluate the use of high performance satellite communications and advanced data communications protocols to enable interactive digital library data access between the U. S. Library of Congress, the National Library of Japan and other digital library sites at 155 MegaBytes Per Second. The ESDC participation in this program is the Trans-Pacific access to GLOBE visualizations in real time. ESDC is participating in the Department of Defense's ATDNet with Multiwavelength Optical Network (MONET) a fully switched Wavelength Division Networking testbed. This presentation is in viewgraph format.

Gary, James Patrick↗
DOE OSTI2025

Assessment of Heavy-Duty Fueling Methods and Components-Modeling and Analysis

The goal of the Assessment of Heavy-Duty Fueling Methods and Components project was to comprehensively assess heavy-duty (HD) fuel cell electric vehicle fueling protocols and their effects on techno-economic assessments (TEA) and total cost of ownership (TCO). The project leveraged and built upon ongoing international HD fueling protocols and fueling component development activities to deliver component performance assessments, modeling tools and methods evaluations, TEA of industry-selected protocol structures, and experimental validations of the strategies at the station scale. The effects of the protocols on the fueling times, station costs, and TCO were explored. Fueling time, which was influenced by temperature and protocol selection, had a large impact on the station cost due to component sizing and satisfying hourly demand. As the fleet size increased, the station cost was shown to exponentially decrease by achieving economies of scale. Technology year and fuel economy were the largest contributors to the TCO; however, the choice of fueling protocol had a minor impact on the TCO.

33 ADVANCED PROPULSION SYSTEMS↗
NASA NTRS2010

MACHETE: Environment for Space Networking Evaluation

Space Exploration missions requires the design and implementation of space networking that differs from terrestrial networks. In a space networking architecture, interplanetary communication protocols need to be designed, validated and evaluated carefully to support different mission requirements. As actual systems are expensive to build, it is essential to have a low cost method to validate and verify mission/system designs and operations. This can be accomplished through simulation. Simulation can aid design decisions where alternative solutions are being considered, support trade-studies and enable fast study of what-if scenarios. It can be used to identify risks, verify system performance against requirements, and as an initial test environment as one moves towards emulation and actual hardware implementation of the systems. We describe the development of Multi-mission Advanced Communications Hybrid Environment for Test and Evaluation (MACHETE) and its use cases in supporting architecture trade studies, protocol performance and its role in hybrid simulation/emulation. The MACHETE environment contains various tools and interfaces such that users may select the set of tools tailored for the specific simulation end goal. The use cases illustrate tool combinations for simulating space networking in different mission scenarios. This simulation environment is useful in supporting space networking design for planned and future missions as well as evaluating performance of existing networks where non-determinism exist in data traffic and/or link conditions.

Jennings, Esther H.↗
NASA NTRS1994

Multiple Hollow Cathode Wear Testing for the Space Station Plasma Contactor

A wear test of four hollow cathodes was conducted to resolve issues associated with the Space Station plasma contactor. The objectives of this test were to evaluate unit-to-unit dispersions, verify the transportability of contamination control protocols developed by the project, and to evaluate cathode contamination control and activation procedures to enable simplification of the gas feed system and heater power processor. These objectives were achieved by wear testing four cathodes concurrently to 2000 hours. Test results showed maximum unit-to-unit deviations for discharge voltages and cathode tip temperatures to be +/-3 percent and +/-2 percent, respectively, of the nominal values. Cathodes utilizing contamination control procedures known to increase cathode lifetime showed no trends in their monitored parameters that would indicate a possible failure, demonstrating that contamination control procedures had been successfully transferred. Comparisons of cathodes utilizing and not utilizing a purifier or simplified activation procedure showed similar behavior during wear testing and pre- and post-test performance characterizations. This behavior indicates that use of simplified cathode systems and procedures is consistent with long cathode lifetimes.

Soulas, George C.↗
NASA NTRS2000

On the Effective Evaluation of TCP

Understanding the performance of the Internet's Transmission Control Protocol (TCP) is important because it is the dominant protocol used in the Internet today. Various testing methods exist to evaluate TCP performance, however all have pitfalls an that need to be understood prior to obtaining useful results. Simulating TCP is difficult because of the wide range of variables, environments, and implementations available. Testing TCP modifications in the global Internet may not be the answer either: testing new protocols on real networks endangers other people's traffic and, if not done correctly, may also yield inaccurate or misleading results. In order for TCP research to be independently evaluated in the Internet research community there is a set of questions that researchers should try to answer. This paper attempts to list some of those questions and make recommendations as to how TCP testing can be structured to be provide useful answers.

Allman, Mark↗
DOE OSTI2022

Xanthohumol microbiome and signature in adults with Crohn’s disease (the XMaS trial): a protocol for a phase II triple-masked, placebo-controlled clinical trial

Xanthohumol (XN), a bioactive flavonoid from Humulus lupulus with anti-inflammatory properties, has potential benefits for patients with Crohn’s disease (CD), a type of inflammatory bowel disease. We recently completed and published results of a placebo-controlled phase I clinical trial demonstrating the safety and tolerability of 24 mg XN daily for 8 weeks. The present study aims to evaluate the safety and tolerability of the same dose of XN adults with clinically active CD in a placebo-controlled phase II clinical trial. Additional aims will assess the impact of XN on inflammatory biomarkers, platelet function, CD clinical activity, and stool microbial composition. The metabolism of XN will also be evaluated. This article provides a model protocol for consideration in investigations of XN or other natural products in disease states. A triple-masked, randomized, placebo-controlled trial will be conducted in adults with clinically active CD. Participants (n ≤ 32) will be randomized to either 24 mg encapsulated XN per day or placebo and followed for 8 weeks. Throughout the trial, participants will be queried for adverse events. Biomarkers of clinical safety, blood and stool markers of inflammation, platelet function, Crohn’s Disease Activity Index score, stool microbial composition, and XN metabolite profiles in blood, urine, and stool will be assessed every 2 weeks. We describe the protocol for a phase II clinical trial that evaluates the safety and tolerability of XN in adults with active CD, as well as evaluate metabolism and mechanisms that are relevant to CD and other diseases with underlying inflammation and/or gut permeability. The effects of XN on inflammatory biomarkers, platelet function, the microbiota, and multi-omics biomarkers measured in this phase II trial of adults with CD will be compared to the effects of XN in healthy adults in our previous phase I trial. The results of the study will advance the evidence guiding the use of XN in patients with CD.

60 APPLIED LIFE SCIENCES↗