Real world evidence on the characteristics of regular and intermittent users of a very-low calorie diet program and associations with measures of program success, health, and quality of life.

Background: Very low-calorie diet (VLCD) programs are readily available in Australia. However, there is a lack of real-world evidence describing the characteristics related to positive outcomes. Aims: To examine the demographic, eating, self-efficacy and program engagement characteristics of VLCD users in Australia, and the associations between user characteristics and program success, weight loss, quality of life (QOL) and health. Method: Cross-sectional data from Australian adults: regular users (n = 189: VLCD user ≥4 days/week for >4 weeks) and intermittent users (n = 111, VLCD user <4 weeks and/or <4 days/week). Self-reported data on demographics, VLCD program use, support, eating behavior, weight-related QOL, mental health, physical health, self-efficacy, and physical activity. Descriptive and inferential statistics were performed in R. Results: Compared to regular users, intermittent users reported lower percentage weight loss (15.1% ± SD 9.8 vs. 9.9% ± SD 6.8, relative to starting weight), fewer reported their VLCD program as very successful (44% vs. 35%), higher depressive symptom scores (8.7 ± SD 2.8 vs. 6.7 ± SD 5.1), and lower general self-efficacy (23.9 ± SD 4.7 vs. 29.4 ± SD 5.7), nutrition self-efficacy (11.9 ± SD 2.0 vs. 14.5 ± SD 3.1) and weight-related QOL scores (60.9 ± SD 22.2 vs. 65.0 ± SD 11.8; p < 0.001 for all). In regular users, older age and longer program duration were associated with greater total weight loss, support, and program success (p < 0.001 for all). In intermittent users, program success was greater when dietitian support was used (odds ratio [OR] 6.50) and for those with higher BMIs (OR 1.08, p < 0.001 for all). In both groups, more frequent support was associated with better weight-related QOL (p < 0.001). Conclusion: This study provides real-world evidence that regular VLCD users had greater success and weight loss than intermittent program users. These findings may be used to tailor and improve the delivery of VLCD programs in Australia and other countries with retail access to VLCDs.

The Impact of Gender-Affirming Hormone Therapy on Physical Performance.

CONTEXT: The inclusion of transgender people in elite sport has been a topic of debate. This narrative review examines the impact of gender-affirming hormone therapy (GAHT) on physical performance, muscle strength, and markers of endurance. EVIDENCE ACQUISITION: MEDLINE and Embase were searched using terms to define the population (transgender), intervention (GAHT), and physical performance outcomes. EVIDENCE SYNTHESIS: Existing literature comprises cross-sectional or small uncontrolled longitudinal studies of short duration. In nonathletic trans men starting testosterone therapy, within 1 year, muscle mass and strength increased and, by 3 years, physical performance (push-ups, sit-ups, run time) improved to the level of cisgender men. In nonathletic trans women, feminizing hormone therapy increased fat mass by approximately 30% and decreased muscle mass by approximately 5% after 12 months, and steadily declined beyond 3 years. While absolute lean mass remains higher in trans women, relative percentage lean mass and fat mass (and muscle strength corrected for lean mass), hemoglobin, and VO2 peak corrected for weight was no different to cisgender women. After 2 years of GAHT, no advantage was observed for physical performance measured by running time or in trans women. By 4 years, there was no advantage in sit-ups. While push-up performance declined in trans women, a statistical advantage remained relative to cisgender women. CONCLUSION: Limited evidence suggests that physical performance of nonathletic trans people who have undergone GAHT for at least 2 years approaches that of cisgender controls. Further controlled longitudinal research is needed in trans athletes and nonathletes.

Association between disordered eating and clinical outcomes following a surgical or endoscopic bariatric procedure: A real-world exploratory study.

Problem: Disordered eating, such as binge, graze, and emotional eating, has been strongly linked to weight gain. Improved understanding of disordered eating by adults who elect bariatric weight loss procedures in a real-world setting is required. Purpose: To determine the association between the number and type of disordered eating patterns (DEPs), as described by healthcare professionals during routine care without standardized assessment, with clinical outcomes in adults who elected a bariatric weight loss procedure. Method: An observational cohort study recruited laparoscopic sleeve gastrectomy (LSG) and endoscopic sleeve gastroplasty (ESG) patients. DEPs documented in the medical record during routine care were observed and tested for association with events (symptoms, side-effects, or adverse events), micronutrient deficiencies, weight loss, and attrition. Data were observed up to 12-month post-procedure. Results: 215 LSG and 32 ESG patients were recruited. The mean number of DEPs was 6.4 (SD: 2.1) and 6.4 (SD: 2.1) in the LSG and ESG cohorts, respectively. Night eating was associated with a higher number of events (p < 0.008) in the LSG cohort, and non-hungry eating was associated with a higher number of events in the ESG cohort (p < 0.001). ESG patients who had a surgical or medical event by 6-months post-procedure had mean 1.78 (95%CI: 0.67, 2.89) more DEPs (p = 0.004). DEPs were not associated with weight loss, micronutrient deficiencies, nor attrition. Conclusion: The treating healthcare team believed the LSG and ESG patients experienced a wide variety and high frequency of DEPs requiring multidisciplinary support. Non-hungry eating and night eating were associated with poorer outcomes following an LSG or ESG. Trial registration: The study was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622000332729).

Implications of gender-affirming endocrine care for sports participation.

Many transgender (trans) individuals utilize gender-affirming hormone therapy (GAHT) to promote changes in secondary sex characteristics to affirm their gender. Participation rates of trans people in sport are exceedingly low, yet given high rates of depression and increased cardiovascular risk, the potential benefits of sports participation are great. In this review, we provide an overview of the evidence surrounding the effects of GAHT on multiple performance-related phenotypes, as well as current limitations. Whilst data is clear that there are differences between males and females, there is a lack of quality evidence assessing the impact of GAHT on athletic performance. Twelve months of GAHT leads to testosterone concentrations that align with reference ranges of the affirmed gender. Feminizing GAHT in trans women increases fat mass and decreases lean mass, with opposite effects observed in trans men with masculinizing GAHT. In trans men, an increase in muscle strength and athletic performance is observed. In trans women, muscle strength is shown to decrease or not change following 12 months of GAHT. Haemoglobin, a measure of oxygen transport, changes to that of the affirmed gender within 6 months of GAHT, with very limited data to suggest possible reductions in maximal oxygen uptake as a result of feminizing GAHT. Current limitations of this field include a lack of long-term studies, adequate group comparisons and adjustment for confounding factors (e.g. height and lean body mass), and small sample sizes. There also remains limited data on endurance, cardiac or respiratory function, with further longitudinal studies on GAHT needed to address current limitations and provide more robust data to inform inclusive and fair sporting programmes, policies and guidelines.

Implementation of multiple statistical methods to estimate variability and individual response to training.

Multiple statistical methods have been proposed to estimate individual responses to exercise training; yet, the evaluation of these methods is lacking. We compared five of these methods including the following: the use of a control group, a control period, repeated testing during an intervention, a reliability trial and a repeated intervention. Apparently healthy males from the Gene SMART study completed a 4-week control period, 4 weeks of High-Intensity Interval Training (HIIT), >1 year of washout, and then subsequently repeated the same 4 weeks of HIIT, followed by an additional 8 weeks of HIIT. Aerobic fitness measurements were measured in duplicates at each time point. We found that the control group and control period were not intended to measure the degree to which individuals responded to training, but rather estimated whether individual responses to training can be detected with the current exercise protocol. After a repeated intervention, individual responses to 4 weeks of HIIT were not consistent, whereas repeated testing during the 12-week-long intervention was able to capture individual responses to HIIT. The reliability trial should not be used to study individual responses, rather should be used to classify participants as responders with a certain level of confidence. 12 weeks of HIIT with repeated testing during the intervention is sufficient and cost-effective to measure individual responses to exercise training since it allows for a confident estimate of an individual's true response. Our study has significant implications for how to improve the design of exercise studies to accurately estimate individual responses to exercise training interventions.HighlightsWhat are the findings? We implemented five statistical methods in a single study to estimate the magnitude of within-subject variability and quantify responses to exercise training at the individual level.The various proposed methods used to estimate individual responses to training provide different types of information and rely on different assumptions that are difficult to test.Within-subject variability is often large in magnitude, and as such, should be systematically evaluated and carefully considered in future studies to successfully estimate individual responses to training.How might it impact on clinical practice in the future?Within-subject variability in response to exercise training is a key factor that must be considered in order to obtain a reproducible measurement of individual responses to exercise training. This is akin to ensuring data are reproducible for each subject.Our findings provide guidelines for future exercise training studies to ensure results are reproducible within participants and to minimise wasting precious research resources.By implementing five suggested methods to estimate individual responses to training, we highlight their feasibility, strengths, weaknesses and costs, for researchers to make the best decision on how to accurately measure individual responses to exercise training.

Uncovering the effects of gender affirming hormone therapy on skeletal muscle and epigenetics: protocol for a prospective matched cohort study in transgender individuals (the GAME study).

INTRODUCTION: Gender affirming hormone therapy (GAHT) is increasingly used by transgender individuals and leads to shifts in sex hormone levels. Skeletal muscle is highly responsive to hormone activity, with limited data on the effects of GAHT on different human tissues. Here, we present the protocol for the GAME study (the effects of Gender Affirming hormone therapy on skeletal Muscle training and Epigenetics), which aims to uncover the effects of GAHT on skeletal muscle 'omic' profiles (methylomics, transcriptomics, proteomics, metabolomics) and markers of skeletal muscle health and fitness. METHODS AND ANALYSIS: This study is a prospective age-matched cohort study in transgender adults commencing GAHT (n=80) and age-matched individuals not commencing GAHT (n=80), conducted at Austin Health and Victoria University in Victoria, Australia. Assessments will take place prior to beginning GAHT and 6 and 12 months into therapies in adults commencing GAHT. Age-matched individuals will be assessed at the same time points. Assessments will be divided over three examination days, involving (1) aerobic fitness tests, (2) muscle strength assessments and (3) collection of blood and muscle samples, as well as body composition measurements. Standardised diets, fitness watches and questionnaires will be used to control for key confounders in analyses. Primary outcomes are changes in aerobic fitness and muscle strength, as well as changes in skeletal muscle DNA methylation and gene expression profiles. Secondary outcomes include changes in skeletal muscle characteristics, proteomics, body composition and blood markers. Linear mixed models will be used to assess changes in outcomes, while accounting for repeated measures within participants and adjusting for known confounders. ETHICS AND DISSEMINATION: The Austin Health Human Research Ethics Committee (HREC) and Victoria University HREC granted approval for this study (HREC/77146/Austin-2021). Findings from this project will be published in open-access, peer-reviewed journals and presented to scientific and public audiences. TRIAL REGISTRATION NUMBER: ACTRN12621001415897; Pre-results.

Vegetable content & variety of convenience cooking product recipes: an online audit of Australian supermarket products.

ABSTARCTMeal/recipe bases are low-cost and popular convenience cooking products, requiring limited preparation time and cooking skills. Back-of-pack recipes provided on these products could help encourage vegetable consumption; however, the vegetable content of these recipes has not been examined. Therefore, an audit was conducted of recipes provided on recipe/meal bases (n = 91) sold online at two Australian supermarkets. Recipes included 1.58 standard serves of vegetables per suggested serving on average, with 75% of recipes providing <2 standard serves of vegetables, and recipes had low vegetable variety. Beef-based recipes had more standard serves of vegetables per standard serving than those based on chicken (p = 0.02). 45% of products had recipes taking <25 minutes. These results provide new insights into the vegetable content of recipes provided on meal and recipe bases and how these recipes could be adjusted to increase vegetable intakes. Results serve as a baseline to track future improvements in these recipes.

Biophysical evidence to support and extend the vitamin D-folate hypothesis as a paradigm for the evolution of human skin pigmentation.

OBJECTIVE: To test the "vitamin D-folate hypothesis for the evolution of human skin pigmentation." METHODS: Total ozone mapping spectrometer (TOMS) satellite data were used to examine surface UV-irradiance in a large (n = 649) Australian cross-sectional study population. Genetic analysis was used to score vitamin D- and folate-related gene polymorphisms (n = 22), along with two pigmentation gene variants (IRF4-rs12203592/HERC2-rs12913832). Red cell folate and vitamin D3 were measured by immunoassay and HPLC, respectively. RESULTS: Ultraviolet radiation (UVR) and pigmentation genes interact to modify blood vitamin levels; Light skin IRF4-TT genotype has greatest folate loss while light skin HERC2-GG genotype has greatest vitamin D3 synthesis (reflected in both TOMS and seasonal data). UV-wavelength exhibits a dose-response relationship in folate loss within light skin IRF4-TT genotype (305 > 310 > 324 > 380 nm). Significant vitamin D3 photosynthesis only occurs within light skin HERC2-GG genotype, and is maximal at 305 nm. Three dietary antioxidants (vitamins C, E, and ß-carotene) interact with UVR and pigmentation genes preventing oxidative loss of labile reduced folate vitamers, with greatest benefit in light skin IRF4-TT subjects. The putative photosensitiser, riboflavin, did not sensitize red cell folate to UVR and actually afforded protection. Four genes (5xSNPs) influenced blood vitamin levels when stratified by pigmentation genotype; MTHFR-rs1801133/rs1801131, TS-rs34489327, CYP24A-rs17216707, and VDR-ApaI-rs7975232. Lightest IRF4-TT/darkest HERC2-AA genotype combination (greatest folate loss/lowest vitamin D3 synthesis) has 0% occurrence. The opposing, commonest (39%) compound genotype (darkest IRF4-CC/lightest HERC2-GG) permits least folate loss and greatest synthesis of vitamin D3 . CONCLUSION: New biophysical evidence supports the vitamin D-folate hypothesis for evolution of skin pigmentation.