A Consensus Time for Performing Quality Control of 225Ac-Labeled Radiopharmaceuticals

Mapping Intimacies ◽

10.21203/rs.3.rs-39342/v2 ◽

2021 ◽

Author(s):

James M. Kelly ◽

Alejandro Amor-Coarasa ◽

Elizabeth Sweeney ◽

Justin J. Wilson ◽

Patrick W. Causey ◽

...

Keyword(s):

Quality Control ◽

Gamma Spectroscopy ◽

Early Time ◽

Average Error ◽

Secular Equilibrium ◽

Data Set ◽

Testing Procedures ◽

Time Points ◽

Consensus Time ◽

Time Point

Abstract Background: As 225Ac-labeled radiopharmaceuticals continue to show promise as targeted alpha therapeutics, there is a growing need to standardize quality control (QC) testing procedures. The determination of radiochemical purity (RCP) is an essential QC test. A significant obstacle to RCP testing is the disruption of the secular equilibrium between actinium-225 and its daughter radionuclides during labeling and analysis. In order to accelerate translation of actinium-225 targeted alpha therapy, we aimed to determine the earliest time point at which the RCP of an 225Ac-labeled radiopharmaceutical can be accurately calculated. Results: Six ligands were conjugated to macrocyclic metal chelators and labeled with actinium-225 under conditions designed to generate diverse incorporation yields. RCP was determined by radio thin layer chromatography (radioTLC) followed by exposure of the TLC plate on a phosphor screen either 0.5, 2, 3.5, 5, 6.5, or 26 h after the plate was developed. The dataset was used to create models for predicting the true RCP using pre-equilibrium measurements at early time points. The 585 TLC measurements span RCP values of 1.8% to 99.5%. The statistical model created from these data predicted an independent data set with high accuracy. Predictions made at 0.5 h are more uncertain than predictions made at later time points. This is primarily due to the decay of bismuth-213. At 2 h the mean average error is < 3%. A measurement of RCP > 90% at this time point predicts a true RCP > 97%. These findings were independently validated using NaI(Tl) scintillation counting and high resolution gamma spectroscopy on a smaller set of samples with 10% ≤ RCP ≤ 100%. Conclusions: RCP of 225Ac-labeled radiopharmaceuticals can be quantified with acceptable accuracy at least 2 h after radioTLC using various methods of quantifying particle emissions. This time point best balances the need to accurately quantify RCP with the need to safely release the batch as quickly as possible.

A Consensus Time for Performing Quality Control of 225Ac-Labeled Radiopharmaceuticals

10.21203/rs.3.rs-39342/v1 ◽

2020 ◽

Author(s):

James M. Kelly ◽

Alejandro Amor-Coarasa ◽

Elizabeth Sweeney ◽

John Babich

Keyword(s):

Quality Control ◽

Early Time ◽

Average Error ◽

Secular Equilibrium ◽

Data Set ◽

Testing Procedures ◽

Time Points ◽

Consensus Time ◽

Layer Chromatography ◽

Time Point

Abstract Background: As 225Ac-labeled radiopharmaceuticals continue to show promise as targeted alpha therapeutics, there is a growing need to standardize quality control (QC) testing procedures. The determination of radiochemical purity (RCP) is an essential QC test. A significant obstacle to RCP testing is the disruption of the secular equilibrium between actinium-225 and its daughter radionuclides during labeling and analysis. In order to accelerate translation of actinium-225 targeted alpha therapy, we aimed to determine the earliest time point at which the RCP of an 225Ac-labeled radiopharmaceutical can be accurately calculated.Results: Six ligands were conjugated to macrocyclic metal chelators and labeled with actinium-225 under conditions designed to generate diverse incorporation yields. RCP was determined by radio thin layer chromatography (radioTLC) followed by exposure of the TLC plate on a phosphor screen either 0.5, 2, 3.5, 5, 6.5, or 26 h after the plate was developed. The dataset was used to create models for predicting the true RCP using pre-equilibrium measurements at early time points. The 585 TLC measurements span RCP values of 1.8% to 99.5%. The statistical model created from these data predicted an independent data set with high accuracy. Predictions made at 0.5 h are more uncertain than predictions made at later time points. This is primarily due to the decay of bismuth-213. At 2 h the mean average error is < 3%. A measurement of RCP > 90% at this time point predicts a true RCP > 97%.Conclusions: RCP of 225Ac-labeled radiopharmaceuticals can be quantified with acceptable accuracy at least 2 h after radioTLC. This time point best balances the need to accurately quantify RCP with the need to safely release the batch as quickly as possible.

A suitable time point for quantifying the radiochemical purity of 225Ac-labeled radiopharmaceuticals

EJNMMI Radiopharmacy and Chemistry ◽

10.1186/s41181-021-00151-y ◽

2021 ◽

Vol 6 (1) ◽

Author(s):

James M. Kelly ◽

Alejandro Amor-Coarasa ◽

Elizabeth Sweeney ◽

Justin J. Wilson ◽

Patrick W. Causey ◽

...

Keyword(s):

Radiochemical Purity ◽

Gamma Spectroscopy ◽

Early Time ◽

Secular Equilibrium ◽

Data Set ◽

Testing Procedures ◽

Layer Chromatography ◽

High Resolution Gamma Spectroscopy ◽

Time Point

Abstract Background As 225Ac-labeled radiopharmaceuticals continue to show promise as targeted alpha therapeutics, there is a growing need to standardize quality control (QC) testing procedures. The determination of radiochemical purity (RCP) is an essential QC test. A significant obstacle to RCP testing is the disruption of the secular equilibrium between actinium-225 and its daughter radionuclides during labeling and QC testing. In order to accelerate translation of actinium-225 targeted alpha therapy, we aimed to determine the earliest time point at which the RCP of an 225Ac-labeled radiopharmaceutical can be accurately quantified. Results Six ligands were conjugated to macrocyclic metal chelators and labeled with actinium-225 under conditions designed to generate diverse incorporation yields. RCP was determined by radio thin layer chromatography (radioTLC) followed by exposure of the TLC plate on a phosphor screen either 0.5, 2, 3.5, 5, 6.5, or 26 h after the plate was developed. The dataset was used to create models for predicting the true RCP for any pre-equilibrium measurement taken at an early time point. The 585 TLC measurements span RCP values of 1.8–99.5%. The statistical model created from these data predicted an independent data set with high accuracy. Predictions made at 0.5 h are more uncertain than predictions made at later time points. This is primarily due to the decay of bismuth-213. A measurement of RCP > 90% at 2 h predicts a true RCP > 97% and guarantees that RCP will exceed 90% after secular equilibrium is reached. These findings were independently validated using NaI(Tl) scintillation counting and high resolution gamma spectroscopy on a smaller set of samples with 10% ≤ RCP ≤ 100%. Conclusions RCP of 225Ac-labeled radiopharmaceuticals can be quantified with acceptable accuracy at least 2 h after radioTLC using various methods of quantifying particle emissions. This time point best balances the need to accurately quantify RCP with the need to safely release the batch as quickly as possible.

Abstract P430: Inflammatory Survival Gene Expression Patterns Differentiate Favorable and Unfavorable Outcomes Following Surgical Intervention in Intracerebral Hemorrhage

Stroke ◽

10.1161/str.52.suppl_1.p430 ◽

2021 ◽

Vol 52 (Suppl_1) ◽

Author(s):

Ifeanyi O Iwuchukwu ◽

doan nguyen ◽

Jasmine Warren ◽

ALIREZA SHIRAZIAN ◽

Vi Tran ◽

...

Keyword(s):

Gene Expression ◽

Surgical Management ◽

Expression Patterns ◽

Early Time ◽

Pcr Analysis ◽

Early Time Point ◽

Time Points ◽

Arginase 1 ◽

Anti Inflammatory ◽

Time Point

Background and Aims: Surgical management of intracerebral (ICH) remains controversial due to unclear benefit. In this study, we analyzed temporal changes in expression of proinflammatory and anti-inflammatory survival genes to discern the molecular differences between favorable and unfavorable outcomes after surgery. Methods: Venous blood collected in Paxgene Blood RNA from ICH patients before surgery at ‘early’ (Day 0-2) and at ‘delayed’ (Day 3-5) timepoints. Extracted total RNA was used for real-time Taqman PCR analysis for anti-inflammatory, survival genes superoxide dismutase 1(SOD1), COX-2, IL-10, peroxisome proliferator activated receptor gamma (PPARG), TGF-B1, and IL-10. The pro-inflammatory genes included arginase-1 (ARG1), TNF, IL-1B, monocyte/macrophage activity markers (CD36, CD163) and NF-kB members (NFKB1, NFKB2, RELA, RELB, REL, NFKBIA). Relative fold changes were determined after normalizing to GAPDH. 90-day Modified Rankin Score (mRS) were collected and classified as favorable, mRS 0-3 (n=4) and unfavorable, mRS 4-6 (n=8). Statistical analysis was carried out by Welch’s ANOVA test (p<0.05). Results: Mean age was 56.25yrs (SD 19.7). ICH location was 10 deep nuclei (thalamus or basal ganglia), 1 cerebellum, and 1 lobar. ICH volume was lower in the mRS 0-3 group (24.15ml SD21.2 vs 35.8ml SD 31.7 p=0.68). All patients had a decompressive hemicraniectomy and 7 included hematoma evacuation. Overall, the NFkB family gene expression was increased at ‘delayed’ relative to the early time points in both groups. However, RELB expression was significantly higher at the early time point of mRS 0-3 compared to mRS 4-6 group. Expression of ARG1, SOD1, COX2, IL-1B, IL-10, TGF-B1, PPARG and CD36 increased significantly at the delayed compared to the early time point. In the unfavorable outcome group (mRS 4-6), TNF expression increased significantly at the delayed timepoints compared to mRS 0-3 which was unchanged. Conclusions: The studied genes were highly expressed and differed significantly between time points. TNF was significantly expressed at the delayed time point in the mRS 4-6 group but unchanged in the mRS 0-3 group. Further studies will explore the role of TNF and related genes in patient selection and outcomes for surgical management of ICH.

Efficacy Trial In An Acute Liver Trauma Animal Model Of Novel Infusible Hemostatic Product: Red Blood Cell-Derived Microparticles (RMP)

Blood ◽

10.1182/blood.v122.21.2342.2342 ◽

2013 ◽

Vol 122 (21) ◽

pp. 2342-2342

Author(s):

Wenche Jy ◽

Max E Johansen ◽

Carlos Bidot ◽

Rifat Pamukcu ◽

Orlando Gomez-Marin ◽

...

Keyword(s):

Blood Pressure ◽

Blood Loss ◽

Early Time ◽

Relative Difference ◽

Control Group ◽

Short Term ◽

Post Injury ◽

Time Points ◽

Time Point

Abstract Background Increasing evidence indicates that natural circulating red cell microparticles (RMP) contribute significantly to hemostasis. Accordingly, we produced RMP in vitro by high pressure extrusion of washed RBCs. We previously reported the hemostatic activity of our RMP product in vitro as well as its efficacy in arresting ear bleeding in rabbits, suggesting the potential of RMP as a hemostatic agent (Jy et al Thromb. Haemost., in press). Here we studied its hemostatic efficacy in a rabbit model of acute liver injury, as well as its short-term toxicity. Methods Male New Zealand White rabbits (mean weight 3.8kg) were randomly selected and assigned, one at a time, to an experimental (n = 9) or a control group (n = 10). All animals were sedated with 35mg/kg ketamine, 5mg/kg xylazine, and 0.01mg/kg glycopyrrolate 15 minutes before surgery. They were intubated and anesthetized with 2% isoflurane, and mechanically ventilated at approximately 20 breaths/min. The carotid artery and the jugular vein were canulated, and maintenance saline was administered at 20mL/hr. The abdomen was cleaned and shaved, and an incision was made from lower tip of the sternum to the bladder. A standardized injury of 9 incisions 30mm long by 4mm deep was inflicted to the liver, and two infusions of RMP (1.25x1011/kg) or saline were delivered via jugular catheter, first immediately post-incision, and again 10 minutes post-incision. Blood was collected in gauze pads at 10 min. intervals and weighed to calculate volume lost. Heart rate, blood pressure (BP), and temperature were continually monitored. The blood pressure (BP) of some of the animals fell very low (MAP<15) by 1 hr post-incision and resulted in death. Only those rabbits that survived 2 hr were used in analysis of blood loss and vital signs. Five of the 10 control rabbits survived 2 hr post-surgery (50%) compared to 5 of the 9 RMP-treated rabbits (56%). All surviving rabbits were euthanized with 0.2mL/kg Euthasol after 120 minutes. Results At early time points (30 – 60 min post-injury) when bleeding was most rapid, administration of RMP had no significant effect: mean (± SD) blood loss at 30 min was 46.1 ± 20.6 mL in the control vs. 26.6 ± 9.0 mL (p=0.07) in the RMP group. At 60 min it was 67.2 ± 24.3 mL vs. 53.4 ± 6.9 mL (p=0.23), respectively. Although at these early time points there were not significant differences, a trend of reduced blood loss was observed. At the 90 min time point, blood loss was 78.6 ± 25.9 mL in the control group compared to 55.7 ± 5.6 mL in the RMP group (p<0.05), a relative difference of ≈ 30%. At 120 min, the corresponding values were 89.8 ± 29.3 mL and 57.7 ± 4.4 mL (p < 0.01), a relative difference of ≈ 36% . Vitals were not significantly different between the control and RMP groups at any time point. Drop in BP tended to be greater in controls than in RMP rabbits. The difference in BP was marginally significant at 120 min. post-injury: systolic BP fell by 39.6 ±17.2 mmHg in controls vs. 18.6 ±15.0 mmHg in RMP-treated (p=0.07). In a short-term toxicity test, quadruple dose (5.0x1011/kg of RMP) was administered and effects observed for three hours: no obvious adverse effects on heart rate, BP, or temperature were observed. Conclusion/Discussion We previously reported dose-dependent reduction by RMP infusion in ear bleeding time of thrombocytopenic rabbits. Efficacy of infusions of RMP is evident in this severe hemorrhagic liver injury model after 30 - 60 min of acute injury when rapid bleeding was substantially slowing down. At 90 and 120 min post-injury, significantly less blood loss was observed in the RMP group compared to the controls, with relative differences of 30% and 36%. Studies are in progress to improve the model and to optimize dosages and scheduling of RMP administration for severe bleeding. Disclosures: No relevant conflicts of interest to declare.

"M3-M6" Molecular Response Evolution As Early Predictor of Outcome Considering Generic Vs Branded TKIs for Chronic Myeloid Leukemia (CML): An Argentine Multicentric Study

Blood ◽

10.1182/blood.v128.22.5445.5445 ◽

2016 ◽

Vol 128 (22) ◽

pp. 5445-5445

Author(s):

Isabel Amanda Giere ◽

María Jose Mela Osorio ◽

Federico Andrés Klosowski ◽

Mariana Debus ◽

Federico Sackmann ◽

...

Keyword(s):

High Risk ◽

Risk Group ◽

Early Time ◽

Transcript Level ◽

High Risk Group ◽

Molecular Response ◽

Molecular Monitoring ◽

Optimal Response ◽

Time Points ◽

Time Point

Abstract Introduction: Early reduction of BCR-ABL transcript level has been associated with improved outcomes in CML treatment. Inability to achieve early molecular response(MR) at 3 months (M3>10%) is considered a predictor factor for unfavourable outcome. However, the kinetics of BCR-ABL transcript level reduction measured at early time points have shown to be an independent predictor of response.The aim of this analysis was to determine whether the "M3-M6" status is critical to categorize CML patients (pts) focusing in high-risk group. Method: Molecular monitoring was performed in all pts prior treatment (M0), at months 3 (M3), 6 (M6), 12 (M12) and every 6 months thereafter, applying Q-PCR method according international recommendations. Results of BCR-ABL1 transcript level were reported on the international scale as IS-BCR-ABL %. Optimal responses: M3≤10%, M6≤1%, M12≤0,1%. Deep responses (MR4.0): ≤0,01% or undetectable/10.000 ABL copies. Results: A total of 70 CML pts were included, median age 49 (19-82), female 39%. First line treatment: sustained branded 81% and generic 19% TKIs. Imatinib 59%, Dasatinib and Nilotinib 41%. Sokal risk score: low (L) 51%, intermediate (In) and high (H) 49%. Optimal responses at molecular milestones: 75% at M3, 72% at M6, 61% at M12 and 53% pts achieved MR4.0. Event-free survival (EFS) was evaluated according to time point M3: M3≤10% group had significantly better EFS compared with the M3>10% (96% vs 70%; P=0.028). M3-M6 status defined 4 groups of pts: M3≤10%-M6≤1%, M3≤10%-M6>1%, M3>10%-M6≤1%, M3>10%-M6>1%. Molecular response evolution by M3-M6 status is described in Table 1. EFS stratified by groups according to combined M3-M6 responses showed significant differences: 92% for group 1, 87% for group 2, 68% for group 3, 54% for group 4. (P=0.002). M6 time point was shown to be critical in 32 high-risk pts (H+In): 17 pts with M6 ≤1% showed significant differences in MR4.0 achievement compared to 15 pts with M6 >1% (82% vs 27% P=0.02). Better EFS was observed in this high-risk group under branded vs generic TKIs treatment (97% vs 54% P=0.04). Statistical differences in deep responses and MMR at M12 were observed between branded and generic TKIs independently of Sokal risk (P=0.06, P=0.02). Conclusions: M3≤10% pts showed a favourable evolution with better EFS than M3>10% group. However not all patients with M3<10% had a similar behavior, showing lower rates of MMR at M12 and deep responses in those pts with M6>1%. In pts with M3 >10% and optimal response at M6 also showed higher MR4.0 rate. Our study supports that M6 is a crucial endpoint to predict MMR at M12 and deep responses in CML pts.Pts with M3≤10% without optimal response at M6 (>1%) had a worse evolution than those slow responders who showed M3>10% and M6≤1%.High-risk pts are still a challenge, observing better outcomes in those under branded TKIs treatment. The M3-M6 status would be a prognostic marker of responses and EFS in chronic phase CML pts treated with TKIs. Our data support the critical role of M6 response in non-optimal M3>10% pts and intermediate and high risk Sokal score. Treatment adherence is mandatory for achieving and sustaining optimal responses. This multicentric Argentine study, reinforces the importance of clinical follow-up and molecular monitoring under IS standardization at early time points. Education on early molecular monitoring with adequate resources must continue to be an objective in our region. Table 1 Table 1. Disclosures Pavlovsky: Roche: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Novartis: Consultancy, Honoraria, Speakers Bureau. Moiraghi:Novartis: Speakers Bureau; Bristol: Speakers Bureau. Varela:Novartis: Speakers Bureau; Bristol: Speakers Bureau. Enrico:Novartis: Honoraria, Patents & Royalties; Bristol Myers squib: Speakers Bureau. Brodsky:International PNH Registry: Other: -; Alexion Pharma Argentina: Speakers Bureau. Pavlovsky:Novartis: Speakers Bureau; Janssen: Speakers Bureau; Bristol Myers Squib: Speakers Bureau.

Cytotoxicity assessment of different doses of ozonated water on dental pulp cells

BMC Oral Health ◽

10.1186/s12903-021-01392-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Ferdiye Küçük ◽

Sibel Yıldırım ◽

Serap Çetiner

Keyword(s):

Cell Viability ◽

Repeated Measures ◽

Dental Pulp ◽

Control Group ◽

Dental Pulp Cells ◽

Time Points ◽

Significant Difference ◽

Pulp Cells ◽

Time Point ◽

Ozonated Water

Abstract Background The purpose of this study was to assess the cytotoxicity of various concentrations of ozonated water (OW) on human primary dental pulp cells. Methods Human primary dental pulp cells were isolated from exfoliated primary canine teeth of an 11-year-old patient with good systemic and oral health. Afterwards, cells were divided into 6 experimental groups; four groups of OW in concentrations of 2 mg/L, 4 mg/L, 8 mg/L, and 16 mg/L, untreated control group, and cell culture without cells. Cytotoxicity was evaluated after exposure for 5-min exposure using Mosmann’s Tetrazolium Toxicity (MTT) assay at 0 h and 48 h time points. Data were analyzed using a repeated measures analysis of variance and Post-hoc tests were performed using Bonferroni correction for multiple comparisons. Results All experimental groups showed proliferation at 0 h time point. However, all groups also experienced a decrease in overtime at 48 h time point (p < 0.05). At both time points 2 mg/L OW showed the highest cell viability as well as proliferation. At 0 h time point, the increase in cell viability for all experimental groups was found statistically significant when compared to positive control group (p < 0.05). At 48 h time point, although 8 mg/L and 16 mg/L OW showed statistically significant reduction in compare to 0 h time point, 2 mg/L and 4 mg/L OW groups didn’t experience any statistically significant difference (p < 0.05). Conclusion Considering our findings, due to ozonated water's induced a higher proliferation rate of dental pulp cells, indicating their biocompatibility and a possible adjuvant on irrigating agent in regenerative endodontic procedures.

Levels of physical activity in four domains and affective wellbeing before and during the Covid-19 pandemic

Archives of Public Health ◽

10.1186/s13690-021-00651-y ◽

2021 ◽

Vol 79 (1) ◽

Author(s):

Eliane S. Engels ◽

Michael Mutz ◽

Yolanda Demetriou ◽

Anne K. Reimers

Keyword(s):

Mental Health ◽

Physical Activity ◽

Protective Factor ◽

Total Sample ◽

Poor Mental Health ◽

German Population ◽

Time Points ◽

Sport And Exercise ◽

Over Time ◽

Time Point

Abstract Background Latest studies indicated that the general mental health level is low during the pandemic. Probably, this deterioration of the mental health situation is partly due to declines in physical activity. The aim of this study was to investigate differences in and the association between affective wellbeing and levels of different domains of physical activity at three time points before and during the pandemic. Method We used a nationwide online panel with a trend data design encompassing a total sample of N = 3517, representing the German population (> 14 years). Four different activity domains (sport and exercise, light outdoor activity, housework/gardening, active travel) and affective wellbeing (positive and negative affect) were assessed at three time points before and during the Covid-19 pandemic (October 2019, March 2020, October 2020). Results Multivariate analyses of variance (MANOVA) indicate differences regarding affective wellbeing over the three time points with the lowest values at the second time point. Levels of activity in the four domains differed significantly over time with the strongest decrease for sport and exercise from the first to the second time point. Partial correlations indicated that the relationships between sport and exercise and positive affect were most consistent over time. Conclusions Overall, our findings suggest that physical activity plays a particularly important role in the pandemic period as a protective factor against poor mental health. Especially sports and exercise seem to be supportive and should be encouraged, e.g. by providing additional support in finding adequate outdoor, home-based or digital substitutes.

Propagation of Voltage Deviations in a Power System

Electronics ◽

10.3390/electronics10080949 ◽

2021 ◽

Vol 10 (8) ◽

pp. 949

Author(s):

Tomasz Okon ◽

Kazimierz Wilkosz

Keyword(s):

Power System ◽

Case Studies ◽

Measurement Data ◽

Theoretical Background ◽

Original Method ◽

Operational Experience ◽

Remedial Measures ◽

Time Points ◽

General Candidate ◽

Time Point

The paper deals with voltage profiles in a power system. The analysis of these profiles is important due to the requirement that the Root-Mean-Squared (RMS) values of nodal voltages should be within certain ranges, as well as to ensure desired power flows in a power system. In both cases, it is desirable to indicate points in a power system where it is reasonable to apply remedial measures to meet the requirements for RMS values of nodal voltages, or to effectively control the power flows in a power system. In general, candidate nodes for remediation are established based on operational experience or measurement data from a certain time point (sometimes from several time points). The paper presents a method that provides a basis for determining the aforementioned candidate nodes based on the behavior of a system over a certain period of time, which is an unquestionable advantage of this proposal. In order to achieve the abovementioned goal, the method provides for the analysis of propagation of voltage RMS value deviations in a power system. The analysis of correlational relationships between the RMS values of nodal voltages is used for this. After presentation of the theoretical background, the new original method is described in the paper. Then, case studies showing the utilization of that method are presented. At the end of the paper, features of the proposed method are enumerated.

Exploring early time points of vimentin assembly in flow by fluorescence fluctuation spectroscopy

Lab on a Chip ◽

10.1039/d0lc00985g ◽

2021 ◽

Vol 21 (4) ◽

pp. 735-745

Author(s):

Eleonora Perego ◽

Sarah Köster

Keyword(s):

Reaction Kinetics ◽

Photon Counting ◽

Early Time ◽

Fluorescence Fluctuation Spectroscopy ◽

Microfluidic Mixing ◽

Time Points ◽

Photon Counting Histogram ◽

Kinetics Of

The combination of photon counting histogram and microfluidic mixing reveals early time points in reaction kinetics of biomolecule aggregation.

Back in Time for Breakfast: An Analysis of the Changing Breakfast Cereal Aisle

Nutrients ◽

10.3390/nu13020489 ◽

2021 ◽

Vol 13 (2) ◽

pp. 489

Author(s):

Emilie Croisier ◽

Jaimee Hughes ◽

Stephanie Duncombe ◽

Sara Grafenauer

Keyword(s):

Dietary Fibre ◽

Saturated Fat ◽

Health Claims ◽

Whole Grain ◽

Breakfast Cereal ◽

Full Data ◽

Data Set ◽

Time Points ◽

Total Fat ◽

Over Time

Breakfast cereal improves overall diet quality yet is under constant scrutiny with assertions that the category has not improved over time. This study aimed to comprehensively analyse the category of breakfast cereals, the nutritional values, and health claims across eight distinct sub-categories at four time points (2013, 2015, 2018, and 2020). An audit of products from four major supermarkets in metropolitan Sydney (Aldi, Coles, IGA, and Woolworths) collected ingredient lists, nutrition information, claims and Health Star Rating (HSR) for biscuits and bites; brans; bubbles, puffs, and flakes; granola and clusters; hot cereal flavoured; hot cereal plain; muesli; breakfast biscuits. The median (IQR) were calculated for energy, protein, fat, saturated fat, carbohydrate, sugars, dietary fibre, and sodium for comparisons over time points by nutrient. Data from 2013 was compared with 2020 (by sub-category and then for a sub-section of common products available at each time point). Product numbers between 2013 (n = 283) and 2020 (n = 543) almost doubled, led by granola and clusters. Whole grain cereals ≥ 8 g/serve made up 67% of products (↑114%). While there were positive changes in nutrient composition over time within the full data set, the most notable changes were in the nutrition composition of cereals marketed as the same product in both years (n = 134); with decreases in mean carbohydrate (2%), sugar (10%) and sodium (16%) (p < 0.000), while protein and total fat increased significantly (p = 0.036; p = 0.021). Claims regarding Dietary Fibre and Whole Grain doubled since 2013. Analysis of sub-categories of breakfast cereal assisted in identifying some changes over time, but products common to both timeframes provided a clearer analysis of change within the breakfast category, following introduction of HSR. Whole grain products were lower in the two target nutrients, sodium and sugars, and well-chosen products represent a better choice within this category.