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3.10. Ethical Considerations | Ethical approval was obtained from the University of KwaZulu-Natal Biomedical Research Ethics Committee (BREC), Makerere University, School of Public Health Higher Degrees Research and Ethics Committee (MaKSPH-HDREC), and the Uganda National Council of Science and Technology (UNCST). The UNSCST has guidelines that supp... | PMC10454402 | ||
4. Conclusions | DISEASE | HPV self-sampling at the HIV clinic could be effective, and would increase the number of women using the service. The prospective implementation of the study will provide insights into the merits and disadvantages of the HPV self-sampling approaches for disease stratification, hence contributing to the best service des... | PMC10454402 | |
Author Contributions | A.N. conceptualized and designed the study, and prepared the initial draft of the study under the supervision of R.W.M.; T.G.G., R.W.M. and T.G.G. all assisted with the manuscript preparation. All authors have read and agreed to the published version of the manuscript. | PMC10454402 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Boards (or Ethics Committee) of Biomedical Research Ethical Committee Higher Degrees (BREC/00002754/2021 and approved on 29 October 2021), Makerere University School of Public Health Higher Degrees Research a... | PMC10454402 | ||
Informed Consent Statement | The study was approved by Makerere University School of Public Health Higher Degrees Research and Ethics Committee (SPH-2021-157), and the Uganda National Council of Science and Technology (HS2084ES). All participants provided informed consent, and were allowed to withdraw consent at any time. | PMC10454402 | ||
Data Availability Statement | The data from this study are the property of the University of KwaZulu-Natal (UKZN) and Makerere University. All interested readers are required to request the data from Makerere University, School of Public Health through the Principal Investigator, Agnes Nyabigambo. Email: | PMC10454402 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10454402 | ||
References | The synopsis of the Health Promotion Model for the study.The map shows the location of Luweero district and Luweero district hospital.Process of recruiting women into the study.Description of the clinic-based (intervention) group and home-based (control) group.Sample size estimation for IDI. | PMC10454402 | ||
Summary | infection | INFECTION | Joint first authors; contributed equallyJoint senior authors; contributed equallyContributorsNHLL and BJC are the principal investigators of this trial and wrote the study protocol. NHLL, GML, and BJC initiated the trial and acquired funding. NHLL, SMSC, CAC, JSMP, SAV, and BJC designed the laboratory testing. NHLL, SM... | PMC10528748 |
Background | SARS-CoV-2 infection | SARS-COV-2 INFECTION | Few trials have compared homologous and heterologous third doses of COVID-19 vaccination with inactivated vaccines and mRNA vaccines. The aim of this study was to assess immune responses, safety, and efficacy against SARS-CoV-2 infection following homologous or heterologous third-dose COVID-19 vaccination with either o... | PMC10528748 |
Methods | VIRUS, PLAQUE | This is an ongoing, randomised, allocation-concealed, open-label, comparator-controlled trial in adults aged 18 years or older enrolled from the community in Hong Kong, who had received two doses of CoronaVac or BNT162b2 at least 6 months earlier. Participants were randomly assigned, using a computer-generated sequence... | PMC10528748 | |
Findings | We enrolled participants from Nov 12, 2021, to Jan 27, 2022. We vaccinated 219 participants who previously received two doses of CoronaVac, including 101 randomly assigned to receive CoronaVac (CC-C) and 118 randomly assigned to receive BNT162b2 (CC-B) as their third dose; and 232 participants who previously received t... | PMC10528748 | ||
Interpretation | infections | INFECTIONS | Similar levels of incidence of, presumably, omicron BA.2 infections were observed in each group despite very weak antibody responses to BA.2 in the recipients of a CoronaVac third dose. Further research is warranted to identify appropriate correlates of protection for inactivated COVID-19 vaccines. | PMC10528748 |
Funding | Health and Medical Research Fund, Hong Kong. | PMC10528748 | ||
Introduction | infection | INFECTION, CNS INFECTIONS, SARS-COV-2 INFECTION | An unprecedented global effort has led to the rapid development and deployment of COVID-19 vaccines.The COVID-19 vaccination programme in Hong Kong (Special Administrative Region, China) initially offered either two doses of CoronaVac (Sinovac Biotech) 28 days apart or two doses of BNT162b2 (Fosun Pharma–BioNTech in ma... | PMC10528748 |
Methods | PMC10528748 | |||
Study design | This study was an open-label, randomised trial of third-dose COVID-19 vaccine (either BNT162b2 or CoronaVac) conducted in the community in Hong Kong. The study protocol was approved by the institutional review board of the University of Hong Kong (ethics approval number UW 21–492), and is available in | PMC10528748 | ||
Participants | allergies | SARS-COV-2 INFECTION, ALLERGIES | Community-dwelling adults were eligible to participate in this study if they were Hong Kong residents, aged 18 years or older at enrolment, and had previously received a complete primary series of either BNT162b2 or CoronaVac, with the second dose received at least 180 days earlier. Exclusion criteria included a histor... | PMC10528748 |
Randomisation and masking | ADVERSE REACTIONS | The field investigation team (research assistants and study nurses) performed final participant eligibility screening before enrolling participants during the vaccination visit. The intervention (ie, third-dose vaccination with CoronaVac or BNT162b2) was randomly preassigned to each individual who passed initial eligib... | PMC10528748 | |
Procedures | RBD | VIRUS, PLAQUE | Participants received the assigned intervention (ie, intramuscular administration of one dose of CoronaVac or BNT162b2), during the enrolment and vaccination visit (day 0) at the community vaccination centre. CoronaVac is a Vero cell-based, aluminium hydroxide-adjuvanted, β-propiolactone-inactivated monovalent vaccine,... | PMC10528748 |
Outcomes | VIRUS, PLAQUE | The primary outcome measure was vaccine (humoral) immunogenicity at 28 days after the third dose of either BNT162b2 or CoronaVac, measured as geometric mean titre (GMT) of SARS-CoV-2 serum neutralising antibodies against the vaccine strain (ancestral virus) using a plaque reduction neutralisation test (PRNT | PMC10528748 | |
Statistical analysis | infection | ADVERSE EVENTS, INFECTION, SARS-COV-2 INFECTION | Based on our preliminary data, assuming a GMT of 27 with an SD of logFor vaccine immunogenicity (primary outcome), we included data from all participants who received the assigned vaccination and provided days 0 and 28 sera samples in our trial (ie, per-protocol analysis). For adverse events, we included all available ... | PMC10528748 |
Role of the funding source | The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. | PMC10528748 | ||
Results | SARS-CoV-2 infection, infections | MAY, SARS-COV-2 INFECTION, INFECTIONS | From Nov 12, 2021, to Jan 27, 2022, we screened 994 individuals, and 818 (82%) passed the initial eligibility assessment (We collected information on post-vaccination reactions in 424 (94%) of 451 participants, including 193 (46%) of 424 who reported ever feeling unwell after vaccination, with significantly more freque... | PMC10528748 |
Discussion | infection, hypertension | ADENOVIRUS, INFECTION, VIRUS, HYPERTENSION | Here, we have conducted a comprehensive assessment of the reactogenicity, antibody response, T-cell responses and risk of omicron BA.2 infection in a randomised trial of homologous and heterologous boosting with BNT162b2 and CoronaVac, both of which used ancestral virus as the vaccine strain. Our population had minimal... | PMC10528748 |
Supplementary Material | PMC10528748 | |||
Acknowledgments | INFECTIOUS DISEASES, ALLERGY | This project was supported by the Health and Medical Research Fund (number COVID19F09), and the Theme-based Research Scheme of the Research Grants Council (RGC) of the Hong Kong Special Administrative Region, China (grant number T11–705/21-N). NHLL is supported by a Health and Medical Research Fund Research Fellowship ... | PMC10528748 | |
Declaration of interests | BJC consults for AstraZeneca, Fosun Pharma, GlaxoSmithKline, Haleon, Moderna, Pfizer, Roche and Sanofi Pasteur. BJC has received research funding from Fosun Pharma. All other authors declare no competing interests.For the Chinese translation of the abstract see Online for See Online for | PMC10528748 | ||
Data sharing | The individual participant data and data dictionary that underlie the results reported in this Article will be shared after de-identification (ie, text, tables, figures, and appendices). Anonymised individual participant data, the data dictionary, and other supporting clinical documents (eg, study protocol and question... | PMC10528748 | ||
References | PMC10528748 | |||
Trial profile | A more detailed flow chart with reasons for exclusion at each stage is provided in | PMC10528748 | ||
Serum neutralising antibodies measured by live virus PRNT (A–C) or by sVNT (D–F) against ancestral SARS-CoV-2, omicron BA.1, and omicron BA.2, respectively, at baseline and 28 days after randomised third-dose CoronaVac or BNT162b2 vaccination | PRNT titres were evaluated with endpoint at 50% inhibition (PRNT | PMC10528748 | ||
IFNγ-producing CD4 | The four study groups included participants who previously received two doses of CoronaVac and were randomly assigned to receive a third dose of CoronaVac (CC-C) or BNT162b2 (CC-B), and participants who previously received two doses of BNT162b2 and were randomly assigned to receive a third dose of CoronaVac (BB-C) or B... | PMC10528748 | ||
Cumulative incidence of SARS-CoV-2 infection after third-dose CoronaVac or BNT162b2 vaccination in adults who previously received two doses of CoronaVac (A) or BNT162b2 (B) within 4–6 months after vaccination and when the omicron BA.2 subvariant was locally circulating | respiratory illness, COPD, fever | ADVERSE REACTIONS, SARS-COV-2 INFECTION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, MAY, COPD | COVID-19 was identified by rapid antigen test or PCR between third-dose vaccination (administered from Nov 12, 2021, to Jan 27, 2022) until May 31, 2022. The four study groups included participants who previously received two doses of CoronaVac and were randomly assigned to receive a third dose of CoronaVac (CC-C) or B... | PMC10528748 |
Research in context | PMC10528748 | |||
Evidence before this study | infection | INFECTION, VIRUS, SECONDARY | Many low-income and middle-income countries use inactivated COVID-19 vaccines in their existing vaccination programmes, and the use of these vaccines has been proposed in high-income countries; however, data comparing inactivated vaccine efficacy with other vaccine platforms are scarce. We searched PubMed and Web of Sc... | PMC10528748 |
Added value of this study | infection, infections | ADVERSE EVENTS, INFECTION, VIRUS, INFECTIONS | We conducted a comprehensive comparative assessment of homologous versus heterologous COVID-19 vaccination using inactivated vaccines and mRNA vaccines, after both primary series of inactivated vaccines or mRNA vaccines, and simultaneously included safety (adverse events and hospitalisations), immunogenicity (live viru... | PMC10528748 |
Implications of all the available evidence | Our findings support the benefit of homologous and heterologous booster doses after a primary series of inactivated and mRNA vaccines. All available evidence on vaccine efficacy and effectiveness of inactivated vaccines against variants, compared with the weak neutralising antibody responses conferred by these vaccines... | PMC10528748 | ||
Background | Edited by: Agnes Szilagyi, Semmelweis University, HungaryReviewed by: Morayma Reyes-Gil, Montefiore Medical Center, United States; Giuseppe Remuzzi, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Italy†These authors share senior authorshipConestat alfa (ConA), a recombinant human C1 inhibitor, may prevent throm... | PMC10641758 | ||
Methods | DISEASE, SECONDARY | We conducted a randomized, open-label, multi-national clinical trial in which hospitalized adults at risk for progression to severe COVID-19 were assigned in a 2:1 ratio to receive either 3 days of ConA plus standard of care (SOC) or SOC alone. Primary and secondary endpoints were day 7 disease severity on the WHO Ordi... | PMC10641758 | |
Results | The trial was prematurely terminated because of futility after randomization of 84 patients, 56 in the ConA and 28 in the control arm. At baseline, higher WHO Ordinal Scale scores were more frequently observed in the ConA than in the control arm. On day 7, no relevant differences in the primary outcome were noted betwe... | PMC10641758 | ||
Conclusion | The study results do not support the use of ConA to prevent COVID-19 progression. | PMC10641758 | ||
Clinical trial registration | PMC10641758 | |||
Introduction | CORONAVIRUS DISEASE 2019 | Numerous efforts have been made to develop effective treatments for individuals who have been hospitalized with Coronavirus disease 2019 (COVID-19) (Conestat alfa (Ruconest | PMC10641758 | |
Materials and methods | PMC10641758 | |||
Study design and patients | obesity, pneumonia, allergy, renal disease, shortness of breath | OBESITY, DISEASE PROGRESSION, PNEUMONIA, ALLERGY, LIVER DISEASE, RENAL DISEASE | This was a randomized, parallel-group, open-label, multi-center trial. The study protocol was published elsewhere (Male and non-pregnant female patients (18–85 years of age) were eligible and approached by study physicians of the participating centers if they had a diagnostic specimen that was positive for SARS-CoV-2 o... | PMC10641758 |
Standard-of-care therapy, randomization, and study medication | PMC10641758 | |||
Randomization | Study participants were randomized in a 2:1 ratio using permuted-block allocation with varying block sizes. Randomization was stratified by the study site, generated by an independent statistician, and implemented via the electronic data capture system software SecuTrial | PMC10641758 | ||
Intervention arm | Patients allocated to the intervention arm received a total of nine intravenous ConA doses over 72 h (8,400 U followed by 4,200 U every 8 h), in addition to SOC treatment. | PMC10641758 | ||
Control arm | Patients allocated to the control arm received SOC only. | PMC10641758 | ||
Monitoring, outcomes, and follow-ups | death, acute lung injury | ADVERSE EVENTS, DISEASE, SECONDARY | Data on vital signs, disease severity according to WHO scale, clinical improvement, admission to ICU, and requirement for non-invasive or invasive ventilation were prospectively obtained. Virological clearance (time from positive to negative PCR test results in nasopharyngeal samples), hematological, liver, renal, and ... | PMC10641758 |
Safety evaluations | The overall incidence of AEs and SAEs were assessed during a 4-week follow-up and documented by the investigators according to seriousness, intensity, causal relationship with study treatment, action taken with study treatment (e.g., withdrawal), specific treatment for AE, and outcome.AE and SAEs were grouped by the or... | PMC10641758 | ||
Statistical plan and analysis | SECONDARY | Full analysis set and intent-to-treat population (FAS/ITTP) was defined as all patients who were randomly allocated to a study arm. The primary efficacy analysis was based on the FAS/ITT population. The primary endpoint was analyzed by Wilcoxon test stratified by its baseline values with a two-sided α-level of 5%. The ... | PMC10641758 | |
Results | PMC10641758 | |||
Patient characteristics | SD, COPD | CHRONIC OBSTRUCTIVE PULMONARY DISEASE, COPD | Between August 2020 and March 2021, 621 patients were screened and 84 were enrolled (Baseline characteristics.ACE, angiotension-converting enzyme; ARB, angiotension receptor blocker; BMI, body mass index; COPD, chronic obstructive pulmonary disease; SD, standard deviation. | PMC10641758 |
Endpoints | DISEASE | Disease severity on day 7, the primary endpoint, was not different in the two groups (Disease severity at day 7.Disease severity on day 7 stratified by baseline scores.Kaplan–Meier curve for the time to clinical improvement within 14 days according to the treatment group. | PMC10641758 | |
Laboratory analyses | Analysis of C1INH concentrations revealed elevated values in both groups at baseline (Course of main laboratory parameters from baseline until day 7 according to the treatment group. Course of | PMC10641758 | ||
Safety | PMC10641758 | |||
Adverse events | Twenty-two subjects had at least one AE: 17 (30%) in the intervention arm and 5 (19%) in the control arm. Overall, 35 AEs were reported: 30 (85.7%) in the interventon arm and 5 (14.3%) in the control arm. Ten of these AEs were attributed to investigations [i.e., laboratory parameters: eight (80.0%) in the intervention ... | PMC10641758 | ||
Serious adverse events | thoracic and mediastinal disorders | CARDIAC DISORDERS | These occurred in 15 (27%) patients in the intervention arm and 4 (15%) in the control arm. The most common system organ classes of the SAEs were “respiratory, thoracic and mediastinal disorders” [10 (17.9%) and 2 (7.4%)], “infections and infestations” [6 (10.7%) and 1 (3.7%)], and “cardiac disorders” [3 (5.4%) and 0].... | PMC10641758 |
Premature trial determination | deaths | While SAEs and deaths were judged as not related to the trial medication, their increased occurrence in the intervention arm led the DSMB to recommend an interruption of the trial after the second interim analysis. In addition, the DSMB recommended to await the outcome data of this analysis, including analyses of the a... | PMC10641758 | |
Discussion | pneumonia, non-critically ill COVID-19 infection, SAEs, infection, viral infections, non-critically ill, sepsis | DISEASE PROGRESSION, PNEUMONIA, DISEASE, VIRAL INFECTION, COMPLICATION, INFECTION, SECONDARY, SEPSIS | This randomized trial found that C1INH treatment added to SOC was not associated with clinical improvement or faster recovery from COVID-19 in comparison with SOC alone in hospitalized, non-critically ill patients. The overall mortality in this trial (7%) was substantially lower than the one previously reported in the ... | PMC10641758 |
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, on reasonable request. | PMC10641758 | ||
Ethics statement | The studies involving humans were approved by the ethics committees «Ethikkommission Nordwest- und Zentralschweiz», «Ethikkommission Ostschweiz», and “Kantonale Ethikkommission Zürich» in Switzerland, “Comissâo Nacional de Ética Em Pesquisa” (CONEP) in Brazil and “Comisión Federal Para La Protección Contra Riesgos Sani... | PMC10641758 | ||
Author contributions | PU: Conceptualization, Data curation, Formal Analysis, Investigation, Methodology, Project administration, Supervision, Visualization, Writing – original draft, Writing – review & editing. ML: Investigation, Project administration, Writing – review & editing. PC: Investigation, Project administration, Writing – review ... | PMC10641758 | ||
Acknowledgments | We thank the trial participants, caregivers, investigators, and research staff who contributed to the trial. We are particularly thankful to the nurses and physicians who cared for the COVID-19 patients during stressful times of the pandemic. We thank Pharming Biotechnologies B.V., Leiden, The Netherlands, for providin... | PMC10641758 | ||
Conflict of interest | MT reports receiving grants from the Swiss National Science Foundation, and having research collaborations with Roche, Novartis, and Idorsia outside the submitted work. WA reports receiving fees and research grants from A. Vogel AG, Gilead, and OM Pharma and fees for attendance of advisory boards to Pfizer, MSD Vifor P... | PMC10641758 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC10641758 | ||
Supplementary material | The Supplementary Material for this article can be found online at: Click here for additional data file. | PMC10641758 | ||
References | PMC10641758 | |||
Abstract | DeceasedPrincipal Investigator: Kentaro YamazakiHiroya Taniguchi and Kentaro Yamazaki Contributed equally as co-first authors. | PMC10628564 | ||
Background | METASTATIC COLORECTAL CANCER | In this phase Ib study MODURATE, we optimized the dosing schedule and tested the efficacy and safety of trifluridine/tipiracil, irinotecan, and bevacizumab in patients with metastatic colorectal cancer with fluoropyrimidine and oxaliplatin treatment failure. | PMC10628564 | |
Methods | We included a dose escalation (3 + 3 design) and an expansion cohort. Patients were administered trifluridine/tipiracil (25-35 mg/m | PMC10628564 | ||
Results | toxicities | Twenty-eight patients were enrolled. Five dose-limiting toxicities were observed. RP2D was defined as trifluridine/tipiracil 35 mg/m | PMC10628564 | |
Conclusion | myelotoxicity | METASTATIC COLORECTAL CANCER | Biweekly trifluridine/tipiracil, irinotecan, and bevacizumab administration may have moderate antitumor activity with high risk of severe myelotoxicity in previously treated patients with metastatic colorectal cancer [UMIN Clinical Trials Registry (UMIN000019828) and Japan Registry of Clinical Trials (jRCTs041180028)].... | PMC10628564 |
Lessons Learned | myelotoxicity | METASTATIC COLORECTAL CANCER | The recommended dose was determined as trifluridine/tipiracil of 35 mg/mBiweekly trifluridine/tipiracil, irinotecan, and bevacizumab administration may have moderate antitumor activity with high risk of severe myelotoxicity in previous treated metastatic colorectal cancer patients. | PMC10628564 |
Discussion | mCRC, tumor, DLTs, myelosuppression | METASTATIC COLORECTAL CANCER, DISEASE, METASTATIC GASTRIC CANCER, TUMOR | Refractory metastatic metastatic colorectal cancer (mCRC) treatment with trifluridine/tipiracil (FTD/TPI) combined with bevacizumab (BEV) or irinotecan (IRI) showed enhanced therapeutic effects in preclinical models.In 18 patients of the dose escalation part, 5 DLTs occurred. We determined that the recommended phase II... | PMC10628564 |
Additional Details of Endpoints or Study Design | PMC10628564 | |||
Study design: | This study was conducted using an open-label, nonrandomized, 2-part phase Ib design and was carried out at 2 centers. The study population consisted of a dose escalation cohort (part 1) to establish the recommended phase II dose (RP2D) for biweekly administration of the combination of FTD/TPI, IRI, and BEV, and an expa... | PMC10628564 | ||
Eligibility criteria: | Tumors, failure of or intolerance | ONCOLOGY, TUMORS | Eligible patients were aged 20-75 years with histologically confirmed CRC, failure of or intolerance to fluoropyrimidine and oxaliplatin treatment (those who showed relapse fewer than 6 months after administration of the final dose of adjuvant chemotherapy were also eligible), and no prior therapy with FTD/TPI and IRI.... | PMC10628564 |
Dose escalation: | toxicity | The dose escalation cohort was formulated based on a traditional 3 + 3 design in which patients in sequential dose-level cohorts received increasing doses of FTD/TPI (25, 30, or 35 m/m2/dose, twice per day for days 1-5) and IRI (150 or 180 mg/mAt least 3 evaluable patients were treated with each dose; 6 patients were t... | PMC10628564 | |
Evaluation | gastrointestinal symptoms, tumor, neutropenia, febrile neutropenia, toxicity, thrombocytopenia, hypertension, Cancer | ADVERSE EVENT, TUMOR, NEUTROPENIA, FEBRILE NEUTROPENIA, ADVERSE EVENT, THROMBOCYTOPENIA, HYPERTENSION, CANCER | The primary endpoint was determination of the RP2D in the dose escalation cohort and frequency of febrile neutropenia in the expansion cohort. Adverse events (AEs) were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.03. A DLT was defined as a cycle of on... | PMC10628564 |
Statistical analyses: | Descriptive statistics were used to summarize patient characteristics and safety and efficacy of the treatment. OS and PFS were estimated using the Kaplan-Meier method. The median OS and PFS and their 95% CIs were analyzed. Log-rank tests were used to compare differences in survival rates. All tests were 2-sided with a... | PMC10628564 | ||
Adverse Events | PMC10628564 | |||
Assessment, Analysis, and Discussion | PPTD, DLTs, diarrhea, toxicities, perforation, proteinurea, myelotoxicity, anorexia | EVENTS, HYPERTENSION, METASTATIC GASTRIC CANCER, ANOREXIA | This phase Ib study indicated that combining IRI and BEV with biweekly FTD/TPI is safe for mCRC treatment. In Japanese mCRC patients pretreated with fluoropyrimidine and oxaliplatin, this regimen showed modest efficacy in this pilot study. To the best of our knowledge, this is the first study to evaluate such a triple ... | PMC10628564 |
Acknowledgments | The authors thank all clinicians for their involvement and contribution to the study. This study was supported by the Fuji Pharma Valley Center, a nonprofit organization. | PMC10628564 | ||
Funding | This study was funded by Taiho Pharmaceutical Co., Ltd under a research contract. | PMC10628564 | ||
Conflict of Interest | Hiroya Taniguchi reported research funding from Taiho and Daiichi-Sankyo, and honoraria from Taiho, Chugai, Daiichi-Sankyo, and Yakult Honsha. Kentaro Yamazaki reported research funding from Taiho and Daiichi-Sankyo, and honoraria from Taiho, Chugai, Daiichi-Sankyo, and Yakult Honsha. Toshiki Masuishi reported research... | PMC10628564 | ||
Data Availability | The data underlying this article will be shared on reasonable request to the corresponding author. | PMC10628564 | ||
References | PMC10628564 | |||
2. Materials and Methods | PMC10745664 | |||
2.1. Test Products | DECAY | The study design and test product composition have been described in detail previously [The group receiving fermented aronia extract will be referred to as FAE and the group receiving non-fermented aronia extract as AE. The aronia extracts were based on aronia berry pulp. The FAE and AE groups were supplemented with sn... | PMC10745664 | |
2.2. Study Design and Participants | RECRUITMENT | This study was carried out at the Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark, spanning the period from December 2020 to April 2022. The study adhered to the principles outlined in the Declaration of Helsinki and received approval from The Central Denmark Region Committees on ... | PMC10745664 | |
2.3. 24 h Ambulatory Blood Pressure Monitoring | pain | The monitoring of 24 h ambulatory blood pressure was conducted using ambulatory blood pressure monitors (Spacelabs Medical, Ebeltoft, Denmark). The monitors were calibrated to measure blood pressure with a half-hour span between 7:00 AM and 11:00 PM, and with an hour span between 11:00 PM and 7:00 AM Participants recor... | PMC10745664 | |
2.4. Blood Analyses | BLOOD | Blood samples were collected following an eight-hour fasting period and promptly underwent centrifugation at 4 °C and 3989 RPM for 10 min. The resulting plasma samples were preserved at −80 °C until the end of the study, when samples from all participants were analysed together. | PMC10745664 | |
2.4.1. Hs-CRP and Adiponectin | Hs-CRP and adiponectin concentrations were measured using non-competitive, time-resolved immunofluorometric assays. The method for the determination of hs-CRP has been described previously by Reinhard et al. [ | PMC10745664 | ||
2.4.2. Lipids | The Department of Clinical Biochemistry at Aarhus University Hospital, Denmark (DS/EN ISO 15189:2013 approved [ | PMC10745664 | ||
2.5. Power Calculation | Based on a power calculation which has been described previously [ | PMC10745664 | ||
2.6. Statistics | Statistical analysis was performed in collaboration with a medical statistician who provided the code for the fitting of a linear mixed effects model in Rstudio (Rstudio, Package lme4). As fixed effects, we included the treatment order (six possible orders), period (first, middle, last), treatment (FAE, AE, placebo), a... | PMC10745664 | ||
3. Results | PMC10745664 |
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