Guidance For Industry Research Articles

Regulation of Intestinal Inflammation by Walnut-Derived Bioactive Compounds.

Walnuts (Juglans regia L.) have shown promising effects in terms of ameliorating inflammatory bowel disease (IBD), attributed to their abundant bioactive compounds. This review comprehensively illustrates the key mechanisms underlying the therapeutic potential of walnuts in IBD management, including the modulation of intestinal mucosa permeability, the regulation of inflammatory pathways (such as NF-kB, COX/COX2, MAPCK/MAPK, and iNOS/NOS), relieving oxidative stress, and the modulation of gut microbiota. Furthermore, we highlight walnut-derived anti-inflammatory compounds, such as polyunsaturated fatty acids (PUFA; e.g., ω-3 PUFA), tocopherols, phytosterols, sphingolipids, phospholipids, phenolic compounds, flavonoids, and tannins. We also discuss unique anti-inflammatory compounds such as peptides and polysaccharides, including their extraction and preparation methods. Our review provides a theoretical foundation for dietary walnut supplementation in IBD management and provides guidance for academia and industry. In future, research should focus on the targeted isolation and purification of walnut-derived anti-inflammatory compounds or optimizing extraction methods to enhance their yields, thereby helping the food industry to develop dietary supplements or walnut-derived functional foods tailored for IBD patients.

A Comprehensive Framework for Evaluating the Value Created by Real-World Evidence for Diverse Stakeholders: The Case for Coordinated Registry Networks.

This manuscript presents a comprehensive framework for the assessment of the value of real-world evidence (RWE) in healthcare decision-making. While RWE has been proposed to overcome some limitations of traditional, one-off studies, no systematic framework exists to measure if RWE actually lowers the burden. This framework aims to fill that gap by providing conceptual approaches for evaluating the time and cost efficiencies of RWE, thus guiding strategic investments in RWE infrastructure. The framework consists of four components: (114th Congress. 21st Century Cures Act.; 2015. https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf .) identification of stakeholders using and producing RWE, (National Health Council. Glossary of Patient Engagement Terms. Published 2019. Accessed May 18. 2021. https://nationalhealthcouncil.org/glossary-of-patient-engagement-terms/ .) understanding value propositions on how RWE can benefit stakeholders, (Center for Drug Evaluation and Research. CDER Patient-Focused Drug Development. U.S. Food & Drug Administration.) defining key performance indicators (KPIs), and (U.S. Department of Health and Human Services - Food and Drug Administration: Center for Devices and Radiological Health and Center for Biologics Evaluation and Research. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff. 2017. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida .) establishing metrics and case studies to assess value. KPIs are categorized as 'better, faster, or cheaper" as an indicator of value: better focusing on high-quality actionable evidence; 'faster,' denoting time-saving in evidence generation, and 'cheaper,' emphasizing cost-efficiency decision compared to methodologies that do not involve data routinely collected in clinical practice. Metrics and relevant case studies are tailored based on stakeholder value propositions and selected KPIs that can be used to assess what value has been created by using RWE compared to traditional evidence-generation approaches and comparing different RWE sources. Operationalized through metrics and case studies drawn from the literature, the value of RWE is documented as improving treatment effect heterogeneity evaluation, expanding medical product labels, and expediting post-market compliance. RWE is also shown to reduce the cost and time required to produce evidence compared to traditional one-off approaches. An original example of a metric that measures the time saved by RWE methods to detect a signal of a product failure was presented based on analysis of the National Cardiovascular Disease Registry. The framework presented in this manuscript offers a comprehensive approach for evaluating the value of RWE, applicable to all stakeholders engaged in leveraging RWE for healthcare decision-making. Through the proposed metrics and illustrated case studies, valuable insights are provided into the heightened efficiency, cost-effectiveness, and improved decision-making within clinical and regulatory domains facilitated by RWE. While this framework is primarily focused on medical devices, it could potentially inform the determination of RWE value in other medical products. By discerning the variations in cost, time, and data utility among various evidence-generation methods, stakeholders are empowered to invest strategically in RWE infrastructure and shape future research endeavors.

An HPLC-UV Method to Assess Human Plasma 25(OH)D3.

The aim of this study was to validate an HPLC-UV method to assess vitamin D status by determining the linearity and precision of the 25-hydroxyvitamin D3 (25(OH)D3) calibration curve, the limits of detection, quantitation and robustness of the method, and its accuracy. A second stock solution of 25(OH)D3 was prepared (500 ng/mL), and working dilutions (5, 10, 20, 30, 40, and 50 ng/mL) were prepared for a calibration curve. The HPLC equipment had a UV-Vis diode-array detector and utilized an AcclaimTM 120 C18 column (5 µm, 4.6 × 250 mm) with a flow rate of 1.2 mL/min, a column temperature of 30 °C, and the standards and samples were maintained at 4 °C, with an injection volume of 100 µL. Detection of 25(OH)D3 was determined at 265 nm, with a retention time of 4.0 min. The validation was conducted according to the FDA Validation of Analytical Procedures: Guidance for Industry. Vitamin D was extracted from plasma samples using acetonitrile (ACN)-0.1% formic acid (2:1 v/v), and the percentage of recovery was calculated. The proposed method conditions gave excellent linearity (R2 = 0.9989) and the linearity coefficient was R2 > 0.99 for 25(OH)D3. The detection and quantification limits were 1.1703 ng/mL and 3.5462 ng/mL, respectively. Decreasing or increasing the reading temperature by 1 °C decreased the response units (AU) of vitamin D, 25(OH)D3. When the current flow rate decreased by 0.2 mL/min (1.0 mL/min), the retention time increased to 4.913 min, whereas an increase of 0.2 mL/min of the proposed flow rate (1.4 mL/min) decreased the retention time to 3.500 min. The percentage of recovery varied from 92.2% to 97.1%. The proposed method to quantify a vitamin D metabolite (25(OH)D3) in human plasma samples was reliable and validated.

Microstructure and properties of Cr12MoV cold work mold steel repaired by wire arc additive manufacturing

The build-up welding repair belongs to the typical wire arc additive manufacturing technology, and can effectively repair the mold, significantly extend the life of the mold, is widely used in the field of mold repair. In this study, Cr12MoV cold work mold steel was repaired using wire arc additive manufacturing. Three build-up welding layers Ni625 (Inconel 625) layer, D322 (CrWMoV steel) layer, and Ni625/D322 double-layer composite build-up layer were designed on the Cr12MoV surface. Temperature field simulation and thermodynamic simulation calculations were used to provide the theoretical basis for microstructural analysis of the build-up welding specimens. The practicality of D322 build-up joint is best. The microstructure of D322 build-up joint is D322 layer (acicular martensite)/PHZ (the fusion zone)/HAZ (the heat-affected zone) Ⅰ (Ld + carbides)/HAZ Ⅱ (martensite + residual austenite + carbides (primary + spherical)/HAZ Ⅲ (martensite + lower bainite)/HAZ Ⅳ (tempered sorbite)/BMZ (the base material). The gradient of hardness distribution in different zones of the D322 build-up joint is the smallest, and the hardness of martensite D322 layer is the highest (702 HV), with the best wear resistance (the friction coefficient and the mass loss are lowest). Moreover, D322 build-up joints in the D322 layer and HAZ Ⅱ brittle fracture, shear strength of 464 MPa. The application of this technology can effectively repair Cr12MoV cold work mold steel and provide guidance for the mold repair industry.

Exploring Virtual Fashion Consumption through the Emotional Three-Level Theory: Reflections on Sustainable Consumer Behavior

The fast fashion industry has been widely criticized for its substantial consumption of resources and significant environmental pollution. In contrast, virtual fashion clothes are attracting attention from consumers and academics for their notable sustainability benefits and potential for fashion innovation. However, research on consumer acceptance of virtual clothes and the role of sustainability remains limited. This study aims to fill this gap by applying the Emotional Three-Level Theory to identify key virtual fashion attributes, including aesthetic, reality, personalization, presentation, sustainability, and inclusivity features, and evaluating their impact on acceptance using the Technology Acceptance Model (TAM). A survey of 503 Generation Z consumers in China, analyzed through structural equation modeling, reveals that perceived enjoyment, usefulness, and ease of use significantly influence the intention to adopt virtual fashion clothes. Aesthetic and realistic features enhance enjoyment, while personalization and presentation improve usefulness and ease of use. Sustainability features positively impact all three factors, promoting consumer acceptance. These findings offer theoretical insights for virtual fashion research and practical guidance for the fashion industry to leverage virtual technologies for environmental sustainability. Notably, the study emphasizes the potential of virtual clothes in promoting sustainable development in the fashion industry.

Research on the Current Situation and Countermeasures for the Development of the Digital Culture Industry in Shiyan City

With the advent of the digital era, the digital culture industry has become a crucial engine for economic growth and cultural innovation. This paper focuses on Shiyan City in Hubei Province, conducting an in-depth analysis of the current state of its digital culture industry. It identifies several challenges faced by Shiyan's digital culture industry, including small industry scale, insufficient diversification, a shortage of digital culture talent, and inadequate policy support. To address these issues and promote high-quality development of the digital culture industry in Shiyan City, the paper proposes the following countermeasures: strengthening policy guidance for the digital culture industry, establishing and improving mechanisms for talent cultivation and recruitment, actively fostering new business forms in the digital culture industry, and vigorously supporting leading enterprises in the digital culture sector.

Three steps toward dose optimization for oncology dose finding

BackgroundTraditional dose selection for oncology registration trials typically employs a one- or two-step single maximum tolerated dose (MTD) approach. However, this approach may not be appropriate for molecularly targeted therapy, which tends to have toxicity profiles that are markedly different than cytotoxic agents. The US Food and Drug Administration launched Project Optimus to reform dose optimization in oncology drug development and has recently released a related guidance for industry. MethodsWe propose a “three steps toward dose optimization” procedure, in response to these initiatives, and discuss the details in dose-optimization designs and analyses. The first step is dose escalation to identify the MTD or maximum administered dose with an efficient hybrid design, which can offer good overdose control and increases the likelihood of the recommended MTD being close to the true MTD. The second step is the selection of appropriate recommended doses for expansion (RDEs), based on all available data, including emerging safety, pharmacokinetics, pharmacodynamics, and other biomarker information. The third step is dose optimization, which uses data from a randomized fractional factorial design with multiple RDEs explored in multiple tumor cohorts during the expansion phase to ensure a feasible dose is selected for registration trials, and that the tumor type most sensitive to the investigative treatment is identified. ConclusionWe believe using this three-step approach can increase the likelihood of selecting an optimal dose for a registration trial that demonstrates a balanced safety profile while retaining much of the efficacy observed at the MTD.

Technological integration of lean manufacturing with industry 4.0 toward lean automation: insights from the systematic review and further research directions

PurposeOrganizations are continually improving their practices to improve operational performance. They already employ Lean Manufacturing techniques (LM) to reduce unnecessary waste. Industry 4.0 techniques enhance operational performance in association with LM. Despite the proven benefits of LM principles and the advancements offered by Industry 4.0 technologies, many organizations struggle to integrate these approaches effectively. This research paper explores how LM principles can be combined with Industry 4.0 technologies to provide valuable guidance for businesses looking to adopt lean automation strategies.Design/methodology/approachA systematic literature review on LM and Industry 4.0 was done to investigate the possible technical integration of both methods. Ninety-two articles are extracted systematically from the Scopus and Web of Science databases. This study states a systematic literature review, including quantitative analysis of bibliographic networks and cluster analysis, to identify emergent ideas and their further implementation.FindingsThe research findings highlight the positive impact of integrating lean production with Industry 4.0 techniques, benefiting organizations in achieving their goals. A lean automation integration framework is proposed based on the literature review and the findings.Practical implicationsThis study provides industry administrators and practitioners valuable guidance for enhancing organizational productivity. These implications can provide businesses with competitive advantages, enhance customer satisfaction, and enable them to adapt to the dynamic demands of the contemporary business environment.Originality/valueThis literature review study has substantially contributed to the technological integration of lean and Industry 4.0. The work has also identified potential emerging areas that warrant further research.

Dose Optimization of Targeted Therapies for Oncologic Indications.

Therapeutic advances in oncology in the 21st century have contributed to significant declines in cancer mortality. Notably, targeted therapies comprised the largest proportion of oncology drugs approved by the United States (US) Food and Drug Administration (FDA) over the past 25 years and have become the standard of care for the treatment of many cancers. However, despite the metamorphosis of the therapeutic landscape, some aspects of cancer drug development have remained essentially unchanged. In particular, the dose-finding methodology originally developed for cytotoxic chemotherapy drugs continues to be implemented, even though this approach no longer represents the most appropriate strategy for modern cancer therapies. In recognition of the need to reconsider assumptions, adapt the dose selection process for newer drugs, and design alternative strategies, the FDA has undertaken several initiatives in recent years to address these concerns. These actions include the launch of Project Optimus in 2021 and the issuance of draft guidance for industry on dose optimization of oncology drugs in 2023. Amid this evolving regulatory environment, the present manuscript reviews case studies for six different targeted cancer therapies, highlighting how dose-finding challenges have been managed to date by oncologists, sponsors, and regulators.

Clinical trial diversity (CTD) scorecards.

e23042 Background: To ensure safety and efficacy, oncology clinical trials must include adequate participation by age, gender, race, and ethnicity subgroups. In November 2020, the US FDA issued Guidance for Industry to increase clinical trial diversity in pivotal clinical trial programs. CARER Group developed the CTD Scorecard to evaluate demographic diversity in registration trial programs for new drugs. Methods: Based on publicly available data, CTD Scorecard assigns each drug a letter grade (A, B, C, D, F) for demographic subgroups-age, race and ethnicity, as well as an overall grade. Scoring includes percentage of subgroup enrolled relative to US population, number of subgroup receiving study drug, and prevalence of disease in each subgroup. Results: From January 2022 to December 2023, US FDA approved 26 new oncology drugs. In this period, 8 trial programs were rated Grade B, 18 received Grade C. Notably, elderly, and female participation was better represented with 23 (88%) and 19 (90%) with Grade A or B respectively. Two trial programs each received Grade C for these subgroups. Asian representation was high, with 54% of programs scoring Grades A or B. Only one drug received Grade D for this demographic and no programs received Graded F. In contrast, Black and Hispanic populations showed significant underrepresentation. Fourteen (54%) of trial programs for Black and thirteen (50%) for Hispanic populations received Grades D or F. Notably, 20 (77% ) of trial programs had ≤10 Black participants receive study drug, with 6 programs having no Black participants receive study drug. Similarly, 14 (54%) of trial programs included ≤ 10 Hispanic participants receiving study drug, and 3 (12%) programs with no Hispanics receiving study drug. During this time, FDA issued Post-Market Requirements or Commitments (PMR/PMC) for 9(35% ) of oncology drugs due to premarket trial diversity shortfalls. However, by CTDs, 20 (77%) of the 26 approved drugs lacked adequate representation, yet did not receive Post-Marketing Requirements or Commitments. Conclusions: Oncology drug safety and efficacy can vary by age, race, sex, and ethnicity, necessitating diverse demographic participation in clinical trials. Alongside US FDA industry guidance, entities like the National Academy of Sciences, Engineering and Medicine and the GAO Report emphasize the need for trial diversity, bolstered by Federal Clinical Diversity Provision H.R. 2617 enacted in 2022. CARER’s scoring system evaluates clinical diversity age, sex, race and ethnicity, based on FDA data since January 2022. Age ≥65, female gender, and Asian race subgroups were generally well represented in clinical trial programs. Black and Hispanic groups show the lowest representation. Consistent use of PMC and PMR to new drugs may improve demographic inclusivity in trials lacking initial diversity.

Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry

BackgroundMedical-product companies often outsource research and manufacturing needs to contracting or partnering organizations but then must manage a challenging patchwork of regulatory activities. A standalone regulatory agreement could clarify the relationships and responsibilities between companies working jointly on a single regulated product. This study explored the need for and current use of standalone regulatory agreements.MethodsA survey instrument was developed using an implementation framework and disseminated to mid- to senior-level employees and consultants for sponsor and vendor companies in the medical products sector.ResultsOf 294 respondents, about half, primarily from companies with more than 200 employees, were familiar with standalone regulatory agreements, and half of this subgroup had moved forward to implement them. Such agreements were considered beneficial to clarify regulatory roles and responsibilities, standardize regulatory expectations between the companies, and stimulate earlier discussion about joint regulatory strategies. However, the development of regulatory agreements appears challenged by the fact that such agreements are not required by regulatory agencies overseeing medical products and have no standardized templates, agency or industry guidance. Respondents whose organizations do not now use regulatory agreements either had not considered or did not see a need for a standalone agreement.ConclusionsStandalone regulatory agreements are becoming more common but are not yet implemented fully by most companies. Their usefulness and content appeared to depend upon the type of partner, the complexity of the relationship and the availability of internal expertise and support.

The Impact of Tourism Policies on the Competitiveness of Tourist Destinations

The tourism sector, as an integral component of the global economy, not only directly propels the economic growth of numerous countries and regions but also fosters cultural exchange and environmental preservation indirectly. On a global scale, the formulation and implementation of tourism policies have become pivotal factors in enhancing the competitiveness of tourist destinations. These policies not only effectively promote infrastructure development and the refinement of tourism products and services but also exert profound influences on environmental conservation, industry guidance, and talent cultivation. Increasingly, countries and regions recognize that scientifically formulated and balanced tourism policies represent an effective means to achieve sustainable economic growth and safeguard cultural heritage. The diversification and innovative implementation of tourism policies directly or indirectly impact the attractiveness and competitiveness of a destination, thus necessitating a comprehensive consideration of multiple factors in policy-making to achieve harmony and equilibrium.

3α-Hydroxylup-20(29)-ene-23,28-dioic Acid as a Phytogenic Chemical Marker for Authenticating Schefflera octophylla (Lour.) Harms Monofloral Honey.

The monofloral honey from Schefflera octophylla (Lour.) Harms (MH-Sco) are of high economic value due to their rarity and potential medicinal benefits. However, the limited investigations on the relationship of phytogenic components between the plant S. octophylla (P-Sco) and MH-Sco have an impact on MH-Sco authentication. Herein, the tentative phytogenic markers of MH-Sco were screened by comparing the metabolites of MH-Sco obtained by ultrahigh-performance liquid chromatography-quadrupole time-of-flight tandem mass spectrometry (UHPLC-Q-TOF-MS/MS)-based untargeted metabolomics with the identified phytogenic chemicals from P-Sco. Combined with the mass and NMR spectral information, 3α-hydroxylup-20(29)-ene-23,28-dioic acid (HLEDA) was finally identified as the phytogenic marker of MH-Sco. A targeted ultrahigh-performance liquid chromatography-triple quadrupole mass spectrometry (UHPLC-QqQ-MS/MS)-based method was established and validated based on the purified monomer standard to measure HLEDA levels in honey samples. HLEDA determined in MH-Sco was with the content from 0.303 to 0.440 mg/kg, while HLEDA was absent in honey samples from other botanical origins, indicating the reliability of HLEDA as a chemical marker in MH-Sco authentication. This study provides the theoretical basis and industry guidance for honey quality control for commercial consumption.

Study on the Formation Mechanism of a Core-Shell Structure during Graphitization of Anthracite.

Graphite is a revolutionary material, and the development of synthetic graphite could potentially solve the shortage of natural graphite in the future. In this paper, the formation of core-shell-structured synthetic graphite prepared from an anthracite-FeO mixture was systematically investigated by a two-step method. First, heat treatment was performed on a layer of almandine (3FeO·Al2O3·3SiO2) particles to obtain a large quantity of uniform-sized glass-phase spheroids. Second, the deashed anthracite was graphitized on the surface of the obtained spheroids to prepare core-shell-structured graphite. Furthermore, the obtained graphite products were systematically characterized by XRD, Raman spectroscopy, SEM-EDS, and TEM. Finally, a model was proposed to illustrate the formation mechanism of the core-shell structure during graphitization of the anthracite-almandine mixture. Under lower temperatures, almandine started to melt into spheroids. Under higher temperatures, the volatile components in the anthracite turned into the gas phase, and the carbon matrix started to bend on the surface of the core material and deposit layer by layer, thus forming the core-shell-structured graphite. The findings could provide theoretical guidance for the synthetic graphite industry and have meaningful implications for the coal chemistry field.

Design Strategy and Consideration for Oncology Dose-Optimization: An Industry Perspective

The conventional more-is-better dose selection paradigm is often inappropriate for novel molecularly targeted agents. In response, the US Food and Drug Administration (FDA) initiated Project Optimus to reform the dose optimization and dose selection paradigm in oncology drug development. Furthermore, the FDA recently also published draft guidance “Optimizing the dosage of human prescription drugs and biological products for the treatment of oncologic diseases guidance for industry,” providing overviews on the rationale, importance, and principles of dose optimization from the regulatory perspective. However, detailed guidance on how to design dose optimization trials is still lacking; it is a key issue faced by drug developers. The article discusses statistical and design strategies of dose optimization in oncology by sharing current industry practice on dose-finding, delineating key statistical components for dose optimization trials, describing available design strategies, and providing recommendations and future directions. This article is a joint work of the Statistical Methods in Oncology Scientific Working Group (Dose-Optimization Workstream) of the American Statistical Association Biopharmaceutical Section.

Strategi Komunikasi Pemasaran MAD For Makeup dalam Menciptakan Brand Image Sebagai Merek Kosmetik untuk Gen Z

This research discusses the marketing communication strategies implemented by MAD For Makeup in an effort to create a brand image as a major player in the cosmetics industry, especially in attracting attention and building engagement with the Generation Z target market. The research method involves a comprehensive analysis of the marketing communication campaigns carried out by MAD For Makeup, with a focus on the use of social media, celebrity endorsements, and product innovation. This research aims to evaluate the extent to which this communication strategy has succeeded in creating a strong and relevant brand image for Generation Z consumers. The findings of this research are expected to provide in-depth insight regarding the impact of marketing communication strategies on brand perception among Generation Z, as well as provide guidance for the cosmetics industry in understanding dynamic market preferences and expectations.

Pharmacokinetic Properties of Baitouweng Decoction in Bama Miniature Pigs: Implications for Clinical Application in Humans.

Traditional Chinese medicine (TCM) serves as a significant adjunct to chemical treatment for chronic diseases. For instance, the administration of Baitouweng decoction (BTWD) has proven effective in the treatment of ulcerative colitis. However, the limited understanding of its pharmacokinetics (PK) has impeded its widespread use. Chinese Bama miniature pigs possess anatomical and physiological similarities to the human body, making them a valuable model for investigating PK properties. Consequently, the identification of PK properties in Bama miniature pigs can provide valuable insights for guiding the clinical application of BTWD in humans. To facilitate this research, a rapid and sensitive UPLC-MS/MS method has been developed for the simultaneous quantification of eleven active ingredients of BTWD in plasma. Chromatographic separation was conducted using an Acquity UPLC HSS T3 C18 column and a gradient mobile phase comprising acetonitrile and water (containing 0.1% acetic acid). The methodology was validated in accordance with the FDA Bioanalytical Method Validation Guidance for Industry. The lower limit of quantitation fell within the range of 0.60-2.01 ng/mL. Pharmacokinetic studies indicated that coptisine chloride, berberine, columbamine, phellodendrine, and obacunone exhibited low Cmax, while fraxetin, esculin, fraxin, and pulchinenoside B4 were rapidly absorbed and eliminated from the plasma. These findings have implications for the development of effective components in BTWD and the adjustment of clinical dosage regimens.

A guide to antimicrobial options for common small ruminant diseases

There are few antibiotics approved for use in small ruminant species in the United States. According to the Animal Medicinal Drug Use Clarification Act (AMDUCA), extralabel drug use may only be employed under the direction of a licensed veterinar­ian in the context of a valid veterinarian-client-patient relation­ship. However, with the implementation of FDA Guidance for Industry #263, producers will no longer have access to antibiot­ics which were previously available over the counter and could have been utilized in an extralabel manner without veterinary oversight. The aim of this discussion is to provide veterinarians with a logical approach to selecting appropriate antibiotics for use in small ruminants.

Protein-starch interaction plays a key role in controlling starch digestion and postprandial glucose increases for moderately milled quinoa grains

Whole grains were reported to exhibit positive effects on management of T2DM. However, the components of whole grains are complex. To clarify which factor played a key role in reducing starch digestion and postprandial glucose increase, quinoa grains with different milling time (MT-0s, 20s, 40s, 80s) were used. As the MT increased, starch digested ratio in vitro and postprandial glucose in vivo increased. Different factors that contributed to this result were further investigated. For starch itself, damaged starch increased from 6.20% in MT-0s to 9.13% in MT-80s. During in vitro gastrointestinal digestion, a maximum of 13.05 mg/g polyphenols were released from quinoa, which was not able to inhibit the activity of α-amylase and α-glucosidase to decrease starch digestion. Besides, the starch digested ratio increased in MT-0s, 20s and 40s as the amount of added trypsin increased, indicating that protein-starch interaction was important for starch digestion. This was also observed in CLSM images. Spearman correlation analysis confirmed that protein content strongly correlated with starch digested ratio compared with other factors. Our results would provide guidance for food processing industry to produce low GI food products.

Research Hotspot and Trend of Digital Clothing Based on Bibliometric Map

Objective: To explore the research status of digital technology in the field of clothing, analyze research hotspots and frontier trends, and provide ideas and references for subsequent research topics. Methods: CNKI database was used as the data source of Chinese literature, Web of Science core database as the data source of English literature, and CiteSpace 6.2.R5 visual tool software was used. This paper visually analyzes the research status of digital technology in the field of clothing from the aspects of cooperation between authors and institutions, keyword co-occurrence, keyword clustering and emergence analysis, and draws correlation maps for comparative study. Results: A total of 118 Chinese literatures and 1418 English literatures were included. The analysis shows that the total number of papers published by Chinese and foreign institutions is on the rise, but there are great differences in research hotspots. The data sources of Chinese literature are mainly digital technology, intelligent clothing, intelligent manufacturing, etc. The data sources of English literature are mainly reflected in the continuous research of social media, clothing industry and purchase intention. Conclusion: Researchers and institutions should grasp the hot spots and trends in the field of digital clothing, strengthen exchanges and cooperation between China and foreign countries, provide theoretical support and practical guidance for academia and industry, promote the effective integration of digital technology and clothing industry, and inject new vitality and innovation.