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A pragmatic, open-label, randomized controlled trial of Plasma-Lyte-148 versus standard intravenous fluids in children receiving kidney transplants (PLUTO).
Hayes, WN, Laing, E, Brown, R, Silsby, L, Smith, L, Thomas, H, Kaloyirou, F, Sharma, R, Griffiths, J, Hume-Smith, H, et al
Kidney international. 2024;(2):364-375
Abstract
Acute electrolyte and acid-base imbalance is experienced by many children following kidney transplant. This is partly because doctors give very large volumes of artificial fluids to keep the new kidney working. When severe, fluid imbalance can lead to seizures, cerebral edema and death. In this pragmatic, open-label, randomized controlled trial, we randomly assigned (1:1) pediatric kidney transplant recipients to Plasma-Lyte-148 or standard of care perioperative intravenous fluids (predominantly 0.45% sodium chloride and 0.9% sodium chloride solutions). We then compared clinically significant electrolyte and acid-base abnormalities in the first 72 hours post-transplant. The primary outcome, acute hyponatremia, was experienced by 53% of 68 participants in the Plasma-Lyte-148 group and 58% of 69 participants in the standard fluids group (odds ratio 0·77 (0·34 - 1·75)). Five of 16 secondary outcomes differed with Plasma-Lyte-148: hypernatremia was significantly more frequent (odds ratio 3·5 (1·1 - 10·8)), significantly fewer changes to fluid prescriptions were made (rate ratio 0·52 (0·40-0·67)), and significantly fewer participants experienced hyperchloremia (odds ratio 0·17 (0·07 - 0·40)), acidosis (odds ratio 0·09 (0·04 - 0·22)) and hypomagnesemia (odds ratio 0·21 (0·08 - 0·50)). No other secondary outcomes differed between groups. Serious adverse events were reported in 9% of participants randomized to Plasma-Lyte-148 and 7% of participants randomized to standard fluids. Thus, perioperative Plasma-Lyte-148 did not change the proportion of children who experienced acute hyponatremia compared to standard fluids. However fewer fluid prescription changes were made with Plasma-Lyte-148, while hyperchloremia and acidosis were less common.
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Individual patient-centered target-driven intervention to improve clinical outcomes of diabetes, health literacy, and self-care practices in Nepal: A randomized controlled trial.
Pardhan, S, Upadhyaya, T, Smith, L, Sharma, T, Tuladhar, S, Adhikari, B, Kidd, J, Sapkota, R
Frontiers in endocrinology. 2023;:1076253
Abstract
PURPOSE To examine the effectiveness of a culturally and linguistically appropriate, patient-centered, target-driven lifestyle intervention with video education training in improving clinical outcomes, health literacy, and diabetic self-care practices in newly diagnosed patients in Nepal. METHODS A total of 110 participants with newly and consequently diagnosed Type 2 were randomly allocated into intervention (mean age = 45 ± 9.7 years) and control (mean age = 47 ± 12.5 years) groups. Intervention group participants were trained on a culturally and linguistically appropriate diabetic video education program and were given a customized dietary and physical activity plan with specific targets to practice at home. Participants' compliance was monitored weekly via telephone calls. Both groups received the usual treatment from their doctor and were followed up after three months. Outcome measures included changes in: i. diabetic health literacy, diet, and physical activity measured using self-reported questionnaires; and ii. blood glucose (glycated hemoglobin, HbA1c), cholesterol, blood pressure, body mass index, and visual acuity. Clinical outcome measures were blinded from randomization and intervention allocation. RESULTS After three months, HbA1c decreased to 6.1% from the baseline value of 7.2% in the intervention group compared to 6.6% in the control group from the baseline value of 7.1% (p <0.05). The intervention group had mean total cholesterol and low-density lipoprotein of 174 and 95.5 mg/dL, which were significantly lower than 186 and 107.5 mg/dL in the control group. Daily white rice consumption decreased by 36.5% in the intervention vs. 4% in the control group (p <0.05). After three months, the intervention group participants exercised more than the control group (p <0.05). All intervention group participants self-initiated retinal screening checks since the baseline visit among which 13% showed early diabetic retinopathy signs compared to 0% in the control group. Health literacy improvement in the intervention group was found to be sustained after three months too. CONCLUSIONS A culturally appropriate, target-driven lifestyle intervention with video education training is effective in improving clinical outcomes, health literacy, and self-care practice in newly diagnosed diabetic patients in Nepal, i.e., at a time period when effective diabetes control is vital to prevent further complications. The training intervention could be rolled out nationwide in order to reduce the risk of diabetic-related complications and improve people's quality of life and productivity.
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Responsiveness and convergent validity of QLU-C10D and EQ-5D-3L in assessing short-term quality of life following esophagectomy.
Bulamu, NB, Vissapragada, R, Chen, G, Ratcliffe, J, Mudge, LA, Smithers, BM, Isenring, EA, Smith, L, Jamieson, GG, Watson, DI, et al
Health and quality of life outcomes. 2021;(1):233
Abstract
AIM: This study assessed the responsiveness and convergent validity of two preference-based measures; the newly developed cancer-specific EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D) relative to the generic three-level version of the EuroQol 5 dimensions (EQ-5D-3L) in evaluating short-term health related quality of life (HRQoL) outcomes after esophagectomy. METHODS Participants were enrolled in a multicentre randomised controlled trial to determine the impact of preoperative and postoperative immunonutrition versus standard nutrition in patients with esophageal cancer. HRQoL was assessed seven days before and 42 days after esophagectomy. Standardized Response Mean and Effect Size were calculated to assess responsiveness. Ceiling effects for each dimension were calculated as the proportion of the best level responses for that dimension at follow-up/post-operatively. Convergent validity was assessed using Spearman's correlation and the level of agreement was explored using Bland-Altman plots. RESULTS Data from 164 respondents (mean age: 63 years, 81% male) were analysed. HRQoL significantly reduced on both measures with large effect sizes (> 0.80), and a greater mean difference (0.29 compared to 0.16) on QLU-C10D. Both measures had ceiling effects (> 15%) on all dimensions at baseline. Following esophagectomy, ceiling effects were observed with self-care (86%), mobility (67%), anxiety/depression (55%) and pain/discomfort (19%) dimensions on EQ-5D-3L. For QLU-C10D ceiling effects were observed with emotional function (53%), physical function (16%), nausea (35%), sleep (31%), bowel problems (21%) and pain (20%). A strong correlation (r = 0.71) was observed between EQ-5D-3L anxiety and QLU-C10D emotional function dimensions. Good agreement (3.7% observations outside the limits of agreement) was observed between the utility scores. CONCLUSION The QLU-C10D is comparable to the more widely applied generic EQ-5D-3L, however, QLU-C10D was more sensitive to short-term utility changes following esophagectomy. Cognisant of requirements by policy makers to apply generic utility measures in cost effectiveness studies, the disease-specific QLU-C10D should be used alongside the generic measures like EQ-5D-3L. TRIAL REGISTRATION The trial was registered with the Australian New Zealand Clinical Trial Registry (ACTRN12611000178943) on the 15th of February 2011.
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Snacking on whole almonds for 6 weeks improves endothelial function and lowers LDL cholesterol but does not affect liver fat and other cardiometabolic risk factors in healthy adults: the ATTIS study, a randomized controlled trial.
Dikariyanto, V, Smith, L, Francis, L, Robertson, M, Kusaslan, E, O'Callaghan-Latham, M, Palanche, C, D'Annibale, M, Christodoulou, D, Basty, N, et al
The American journal of clinical nutrition. 2020;(6):1178-1189
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Abstract
BACKGROUND There is convincing evidence that daily whole almond consumption lowers blood LDL cholesterol concentrations, but effects on other cardiometabolic risk factors such as endothelial function and liver fat are still to be determined. OBJECTIVES We aimed to investigate whether isoenergetic substitution of whole almonds for control snacks with the macronutrient profile of average snack intakes, had any impact on markers of cardiometabolic health in adults aged 30-70 y at above-average risk of cardiovascular disease (CVD). METHODS The study was a 6-wk randomized controlled, parallel-arm trial. Following a 2-wk run-in period consuming control snacks (mini-muffins), participants consumed either whole roasted almonds (n = 51) or control snacks (n = 56), providing 20% of daily estimated energy requirements. Endothelial function (flow-mediated dilation), liver fat (MRI/magnetic resonance spectroscopy), and secondary outcomes as markers of cardiometabolic disease risk were assessed at baseline and end point. RESULTS Almonds, compared with control, increased endothelium-dependent vasodilation (mean difference 4.1%-units of measurement; 95% CI: 2.2, 5.9), but there were no differences in liver fat between groups. Plasma LDL cholesterol concentrations decreased in the almond group relative to control (mean difference -0.25 mmol/L; 95% CI: -0.45, -0.04), but there were no group differences in triglycerides, HDL cholesterol, glucose, insulin, insulin resistance, leptin, adiponectin, resistin, liver function enzymes, fetuin-A, body composition, pancreatic fat, intramyocellular lipids, fecal SCFAs, blood pressure, or 24-h heart rate variability. However, the long-phase heart rate variability parameter, very-low-frequency power, was increased during nighttime following the almond treatment compared with control (mean difference 337 ms2; 95% CI: 12, 661), indicating greater parasympathetic regulation. CONCLUSIONS Whole almonds consumed as snacks markedly improve endothelial function, in addition to lowering LDL cholesterol, in adults with above-average risk of CVD.This trial was registered at clinicaltrials.gov as NCT02907684.
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Snacking on Whole Almonds for Six Weeks Increases Heart Rate Variability during Mental Stress in Healthy Adults: A Randomized Controlled Trial.
Dikariyanto, V, Smith, L, Chowienczyk, PJ, Berry, SE, Hall, WL
Nutrients. 2020;(6)
Abstract
Cardiac autonomic regulation can be indirectly measured by heart rate variability (HRV). Low HRV, which can be induced by mental stress, is a predictor of risk of sudden cardiac death. Few studies have investigated cause-and-effect relationships between diet and HRV. Nut consumption is associated with CVD risk reduction, but the impact on HRV, particularly in response to stress, is unclear. Men and women (30-70 y) with above average risk of developing CVD were randomly assigned in a 6-week randomized, controlled, parallel arm trial to consume either whole almond or isocaloric control snacks (20% of daily estimated energy requirement). Control snacks contained the average nutrient profile of UK snacks. Five-minute periods of supine heart rate (HR) and HRV were measured at resting and during mental stress (Stroop color-word test) at baseline and six weeks. High frequency (HF) power, which reflects parasympathetic regulation of HR, was increased following almonds during the mental stress task relative to control (mean difference between groups 124 ms2; 95% CI 11, 237; p = 0.031, n = 105), but other indices were unaffected. Snacking on whole almonds instead of typical snacks may reduce risk of CVD partly by ameliorating the suppression of HRV during periods of mental stress.
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Effect of a short-term low fermentable oligiosaccharide, disaccharide, monosaccharide and polyol (FODMAP) diet on exercise-related gastrointestinal symptoms.
Wiffin, M, Smith, L, Antonio, J, Johnstone, J, Beasley, L, Roberts, J
Journal of the International Society of Sports Nutrition. 2019;16(1):1
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Plain language summary
A diet high in fermentable oligosaccharides, disaccharides, monosaccharaides and polyols (FODMAPs) may result in altered gut motility. Research has shown that 30-50% of endurance athletes list gastrointestinal (GI) issues as a cause of underperformance, however there is little evidence on the impact of FODMAPs during endurance training. The aim of this randomised, crossover trial was to determine the effects of a short-term, low FODMAP diet on GI symptoms and perceived ability to exercise in 16 healthy volunteers. Participants were randomly assigned to either a low FODMAP diet or high FODMAP diet for seven days with a seven-day washout period. GI symptoms, perceived ability to exercise and markers of acute GI inflammation were recorded at the beginning and end of each intervention period. This study found a short-term, low FODMAP diet reduced exercise-related GI symptoms and improved perceived ability to exercise compared with a high FODMAP diet. Based on these results, the authors recommend the therapeutic benefits of a sustained low FODMAP diet in athletes be further explored.
Abstract
BACKGROUND Research has demonstrated that low fermentable oligiosaccharide, disaccharide, monosaccharide and polyol (FODMAP) diets improve gastrointestinal (GI) symptoms in irritable bowel syndrome sufferers. Exercise-related GI issues are a common cause of underperformance, with current evidence focusing on the use of FODMAP approaches with recreationally competitive or highly trained athletes. However, there is a paucity of research exploring the potential benefit of FODMAP strategies to support healthy, recreational athletes who experience GI issues during training. This study therefore aimed to assess whether a short-term LOWFODMAP diet improved exercise-related GI symptoms and the perceived ability to exercise in recreational runners. METHODS Sixteen healthy volunteers were randomly assigned in a crossover design manner to either a LOWFODMAP (16.06 ± 1.79 g·d- 1) or HIGHFODMAP (38.65 ± 6.66 g·d- 1) diet for 7 days, with a one week washout period followed by a further 7 days on the alternate diet. Participants rated their gastrointestinal symptoms on an adapted version of the Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) questionnaire before and at the end of each dietary period. Perceived ability to exercise (frequency, intensity and duration) in relation to each dietary period was also rated using a visual analogue scale. Resting blood samples were collected prior to and on completion of each diet to determine plasma intestinal fatty acid binding protein (I-FABP) as a marker of acute GI injury. RESULTS Overall IBS-SSS score significantly reduced in the LOWFODMAP condition from 81.1 ± 16.4 to 31.3 ± 9.2 (arbitrary units; P = 0.004). Perceived exercise frequency (z = 2.309, P = 0.02) and intensity (z = 2.687, P = 0.007) was significantly improved following a short-term LOWFODMAP approach compared to HIGHFODMAP. No significant differences were reported between dietary conditions for plasma I-FABP (P > 0.05). CONCLUSIONS A short-term LOWFODMAP diet under free-living conditions reduced exercise-related GI symptoms and improved the perceived ability to exercise in otherwise healthy, recreational runners. These findings may be explained by a reduction in indigestible carbohydrates available for fermentation in the gut. The therapeutic benefits of LOWFODMAP diets in recreational and trained athletes during sustained training periods warrants further investigation.
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The comparative effects of 3% saline and 0.5M sodium lactate on cardiac function:a randomised, crossover study in volunteers.
Nalos, M, Kholodniak, E, Smith, L, Orde, S, Ting, I, Slama, M, Seppelt, I, McLean, AS, Huang, S
Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine. 2018;(2):124-130
Abstract
OBJECTIVE To investigate the metabolic and cardiac effects of intravenous administration of two hypertonic solutions - 3% saline (SAL) and 0.5M sodium lactate (LAC). DESIGN, SETTING AND PARTICIPANTS A randomised, doubleblind, crossover study in ten human volunteers. Intravenous bolus of either SAL or LAC at 3 mL/kg over 20 min followed by a 2 mL/kg infusion over 60 min. MAIN OUTCOME MEASURES Acid base parameters and echocardiographic indices of cardiac function, cardiac output (CO), left ventricular ejection fraction (LVEF) and mitral annular peak systolic velocity (Sm) before and after infusion of SAL or LAC. RESULTS Despite haemodilution, we observed an increase in sodium (139 ± 2 mmol/L to 142 ± 2 mmol/L in both groups) and respective anions, chloride (106 ± 2 mmol/L to 112 ± 3 mmol/L) and lactate (1.01 ± 0.28 mmol/L to 2.38 ± 0.38 mmol/L) with SAL and LAC, respectively. The pH (7.37 ± 0.03 to 7.45 ± 0.03; P < 0.01) and simplified strong ion difference (SID) (36.3 ± 4.6 mmol/L to 39.2 ± 3.6 mmol/L; P < 0.01) increased during the LAC infusion. The pH was unchanged, but SID decreased during SAL infusion (36.3 ± 2.5 mmol/L to 33.9 ± 3.1 mmol/L; P = 0.01). Both solutions led to an increase in preload and cardiac function, CO (4.36 ± 0.79 L/min to 4.98 ± 1.37 L/ min v 4.62 ± 1.30 L/min to 5.13 ± 1.44 L/min), LVEF (61 ± 6% to 63 ± 8% v 64 ± 6% to 68 ± 7%). The averaged Sm improved in the LAC group as compared with the SAL group (0.088 ± 0.008 to 0.096 ± 0.016 v 0.086 ± 0.012 to 0.082 ± 0.012; P = 0.032). CONCLUSIONS The administration of SAL or LAC has opposing effects on acid base variables such as SID. Hypertonic fluid infusion lead to increased cardiac preload and performance with Sm, suggesting better left ventricular systolic function during LAC as compared with SAL. Lactated hypertonic solutions should be evaluated as resuscitation fluids.
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Multicentre factorial randomized clinical trial of perioperative immunonutrition versus standard nutrition for patients undergoing surgical resection of oesophageal cancer.
Mudge, LA, Watson, DI, Smithers, BM, Isenring, EA, Smith, L, Jamieson, GG, ,
The British journal of surgery. 2018;(10):1262-1272
Abstract
BACKGROUND Preoperative immunonutrition has been proposed to reduce the duration of hospital stay and infective complications following major elective surgery in patients with gastrointestinal malignancy. A multicentre 2 × 2 factorial RCT was conducted to determine the impact of preoperative and postoperative immunonutrition versus standard nutrition in patients with oesophageal cancer. METHODS Patients were randomized before oesophagectomy to immunonutrition (IMPACT® ) versus standard isocaloric/isonitrogenous nutrition, then further randomized after operation to immunonutrition versus standard nutrition. Clinical and quality-of-life outcomes were assessed at 14 and 42 days after operation on an intention-to-treat basis. The primary outcome was the occurrence of infective complications. Secondary outcomes were other complications, duration of hospital stay, mortality, nutritional and quality-of-life outcomes (EuroQol EQ-5D-3 L™, European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC QLQ-OES18). Patients and investigators were blinded until the completion of data analysis. RESULTS Some 278 patients from 11 Australian sites were randomized; two were excluded and data from 276 were analysed. The incidence of infective complications was similar for all groups (37 per cent in perioperative standard nutrition group, 51 per cent in perioperative immunonutrition group, 34 per cent in preoperative immunonutrition group and 40 per cent in postoperative immunonutrition group; P = 0·187). There were no significant differences in any other clinical or quality-of-life outcomes. CONCLUSION Use of immunonutrition before and/or after surgery provided no benefit over standard nutrition in patients undergoing oesophagectomy. Registration number: ACTRN12611000178943 ( https://www.anzctr.org.au).
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Satiating Effect of High Protein Diets on Resistance-Trained Subjects in Energy Deficit.
Roberts, J, Zinchenko, A, Mahbubani, K, Johnstone, J, Smith, L, Merzbach, V, Blacutt, M, Banderas, O, Villasenor, L, Vårvik, FT, et al
Nutrients. 2018;(1)
Abstract
Short-term energy deficit strategies are practiced by weight class and physique athletes, often involving high protein intakes to maximize satiety and maintain lean mass despite a paucity of research. This study compared the satiating effect of two protein diets on resistance-trained individuals during short-term energy deficit. Following ethical approval, 16 participants (age: 28 ± 2 years; height: 1.72 ± 0.03 m; body-mass: 88.83 ± 5.54 kg; body-fat: 21.85 ± 1.82%) were randomly assigned to 7-days moderate (PROMOD 1.8 g·kg-1·d-1) or high protein (PROHIGH 2.9 g·kg-1·d-1) matched calorie-deficit diets in a cross-over design. Daily satiety responses were recorded throughout interventions. Pre-post diet, plasma ghrelin and peptide tyrosine tyrosine (PYY), and satiety ratings were assessed in response to a protein-rich meal. Only perceived satisfaction was significantly greater following PROHIGH (67.29 ± 4.28 v 58.96 ± 4.51 mm, p = 0.04). Perceived cravings increased following PROMOD only (46.25 ± 4.96 to 57.60 ± 4.41 mm, p = 0.01). Absolute ghrelin concentration significantly reduced post-meal following PROMOD (972.8 ± 130.4 to 613.6 ± 114.3 pg·mL-1; p = 0.003), remaining lower than PROHIGH at 2 h (-0.40 ± 0.06 v -0.26 ± 0.06 pg·mL-1 normalized relative change; p = 0.015). Absolute PYY concentration increased to a similar extent post-meal (PROMOD 84.9 ± 8.9 to 147.1 ± 11.9 pg·mL-1, PROHIGH 100.6 ± 9.5 to 143.3 ± 12.0 pg·mL-1; p < 0.001), but expressed as relative change difference was significantly greater for PROMOD at 2 h (+0.39 ± 0.20 pg·mL-1 v -0.28 ± 0.12 pg·mL-1; p = 0.001). Perceived hunger, fullness and satisfaction post-meal were comparable between diets (p > 0.05). However, desire to eat remained significantly blunted for PROMOD (p = 0.048). PROHIGH does not confer additional satiating benefits in resistance-trained individuals during short-term energy deficit. Ghrelin and PYY responses to a test-meal support the contention that satiety was maintained following PROMOD, although athletes experiencing negative symptoms (i.e., cravings) may benefit from protein-rich meals as opposed to over-consumption of protein.
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The effect of two β-alanine dosing strategies on 30-minute rowing performance: a randomized, controlled trial.
Beasley, L, Smith, L, Antonio, J, Gordon, D, Johnstone, J, Roberts, J
Journal of the International Society of Sports Nutrition. 2018;(1):59
Abstract
BACKGROUND β-alanine (βA) supplementation has been shown to increase intramuscular carnosine content and subsequent high-intensity performance in events lasting < 4 minutes (min), which may be dependent on total, as opposed to daily, dose. The ergogenic effect of βA has also been demonstrated for 2000-m rowing performance prompting interest in whether βA may be beneficial for sustained aerobic exercise. This study therefore investigated the effect of two βA dosing strategies on 30-min rowing and subsequent sprint performance. METHODS Following University Ethics approval, twenty-seven healthy, male rowers (age: 24 ± 2 years; body-height: 1.81 ± 0.02 m; body-mass: 82.3 ± 2.5 kg; body-fat: 14.2 ± 1.0%) were randomised in a double-blind manner to 4 weeks of: i) βA (2.4 g·d- 1, βA1); ii) matched total βA (4.8 g on alternate days, βA2); or iii) cornflour placebo (2.4 g·d- 1, PL). Participants completed a laboratory 30-min rowing time-trial, followed by 3x30-seconds (s) maximal sprint efforts at days 0, 14 and 28 (T1-T3). Total distance (m), average power (W), relative average power (W·kg- 1), cardio-respiratory measures and perceived exertion were assessed for each 10-min split. Blood lactate ([La-]b mmol·L- 1) was monitored pre-post time-trial and following maximal sprint efforts. A 3-way repeated measures ANOVA was employed for main analyses, with Bonferonni post-hoc assessment (P ≤ 0.05). RESULTS Total 30-min time-trial distance significantly increased from T1-T3 within βA1 only (7397 ± 195 m to 7580 ± 171 m, P = 0.002, ƞp2 = 0.196), including absolute average power (194.8 ± 18.3 W to 204.2 ± 15.5 W, P = 0.04, ƞp2 = 0.115) and relative average power output (2.28 ± 0.15 W·kg- 1 to 2.41 ± 0.12 W·kg- 1, P = 0.031, ƞp2 = 0.122). These findings were potentially explained by within-group significance for the same variables for the first 10 min split (P ≤ 0.01), and for distance covered (P = 0.01) in the second 10-min split. However, no condition x time interactions were observed. No significant effects were found for sprint variables (P > 0.05) with comparable values at T3 for mean distance (βA1: 163.9 ± 3.8 m; βA2: 161.2 ± 3.5 m; PL: 162.7 ± 3.6 m), average power (βA1: 352.7 ± 14.5 W; βA2: 342.2 ± 13.5 W; PL: 348.2 ± 13.9 W) and lactate (βA1: 10.0 ± 0.9 mmol·L- 1; βA2: 9.2 ± 1.1 mmol·L- 1; PL: 8.7 ± 0.9 mmol·L- 1). CONCLUSIONS Whilst daily βA may confer individual benefits, these results demonstrate limited impact of βA (irrespective of dosing strategy) on 30-min rowing or subsequent sprint performance. Further investigation of βA dosage > 2.4 g·d- 1 and/or chronic intervention periods (> 4-8 weeks) may be warranted based on within-group observations.