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An algorithm for differentiating food antigen-related gastrointestinal symptoms.
Rostami, K, Bold, J, Ismail Ali, J, Parr, A, Dieterich, W, Zopf, Y, Htoo, A, Rostami-Nejad, M, Danciu, M
Gastroenterology and hepatology from bed to bench. 2021;14(1):8-16
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Irritable bowel syndrome (IBS) is a collection of gastrointestinal symptoms. Due to multiple etiologies, the pathogenesis of IBS is poorly understood. The aim of this audit was to assess the outcomes achieved using a lactose and gluten-free diet clinical intervention in patients traditionally diagnosed with IBS. This study was an audit of outcomes from the records of 149 patients presenting with IBS symptoms at secondary and tertiary Gastroenterology outpatients in two UK hospitals. This audit has demonstrated that more than 70% of patients presenting with IBS symptoms improved by following a diet eliminating lactose and gluten containing grains (improvement for >30% in their symptoms). The success of the elimination diet did not seem to be correlated with the body mass index (BMI). The best outcome was recorded in patients with normal BMI and also in the overweight group. Patients with higher BMI >30 or low below 18 also responded well to nutrition therapy. In conclusion, multidisciplinary team management and implementation of detailed nutrition therapy using the audit algorithm might prove to be both cost effective and efficacious a treatment option in IBS.
Abstract
AIM: The aim of this clinical audit was to assess patient-reported outcomes on the effect of dietary intervention, to enhance our understanding of possible treatment options in irritable bowel syndrome (IBS). BACKGROUND A large number of food-related gastro-intestinal disorders have been attributed to IBS for decades. METHODS Patient-reported outcomes from the records of 149 IBS patients treated at secondary and tertiary Gastroenterology outpatients in two UK hospitals between January 2014 and July 2016 were audited. Patients all presented with symptoms fulfilling Rome III-IV criteria for IBS had negative coeliac serology and did not have other gastrointestinal (GI) conditions. A modified version of a low FODMAP diet had been recommended (gluten and lactose free diet (G/LFD)) and was implemented for 6 weeks. Outcomes and dietary adherence were recorded during outpatient's consultations. RESULTS A total of 134 patients complied with the diet optimally. The majority had an improvement rate >70% and continued with the diet. Fifty-three percent became completely or almost asymptomatic, while 27.6% had a poor response to the diet (scoring < 30%) to G/LFD. The improvement was excellent in patients with normal BMI and good in overweight and obese and where BMI <18. Over 50% did not require any follow-up within 12 months. CONCLUSION Although it is unclear whether symptoms are triggered by gluten, fructans or lactose, elimination of gluten and lactose proved to be an effective treatment in patients with IBS. Multidisciplinary team management and implementation of detailed nutrition therapy using the audit algorithm might prove to be both cost effective and efficacious a treatment option in IBS.
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The Effects of a High-Protein Dairy Milk Beverage With or Without Progressive Resistance Training on Fat-Free Mass, Skeletal Muscle Strength and Power, and Functional Performance in Healthy Active Older Adults: A 12-Week Randomized Controlled Trial.
Huschtscha, Z, Parr, A, Porter, J, Costa, RJS
Frontiers in nutrition. 2021;:644865
Abstract
The study aimed to investigate the independent and combined effects of consuming a high-protein dairy milk beverage, twice daily, with or without a progressive resistance training (PRT) program on outcomes of age-related sarcopenia, in healthy active older (≥50 years) adults. In this 12-week, 2 × 2 factorial study, participants were randomly allocated into one of four groups: dairy milk beverage (DM), exercise and dairy milk beverage (EX+DM), exercise alone (EX), and control (CON). The EX group underwent a 12-week whole-body PRT schedule (three sessions/week) and a high-protein dairy milk beverage (DM) was consumed twice daily (30 g protein/day). At weeks 0, 6, and 12, body composition (iDXA), strength [one-repetition maximum (1RM): leg press, chest press, lateral (lat) pull-down, and handgrip], power (countermovement jump), cardiorespiratory fitness (VO2), and physical performance (gait speed) were measured. Before measurements, blood samples were collected to determine the immune (i.e., leukocyte trafficking and inflammatory cytokines) and hormonal (i.e., insulin, cortisol, IGF-1, testosterone, and estradiol) profiles. Participants (n = 37) completed the study within the controlled experimental conditions. Protein intake increased in the EX+DM [mean ± SD, 1.2 ± 0.2 to 1.8 ± 0.4 g/kg body mass (BM) per day-1] and DM (1.3 ± 0.5 to 1.8 ± 0.6 g kg-1 BM day-1) groups during the intervention. Absolute fat-free mass increased in the EX+DM [mean (95% confidence interval) = 0.65 (0.25-1.0) kg] and EX [0.49 (-0.44 to 1.40) kg] groups (P < 0.001) compared to DM [-0.54 (-1.6 to 0.05) kg]. Relative fat mass decreased (group*time, P = 0.018) in DM [-1.8% (-3.3 to -0.35%)] and EX+DM [-1.3% (-2.3 to -0.31%)], which was a greater reduction than that in the CON [0.10% (-0.80 to 1.0%)] group (P < 0.01). Relative maximal strength increased in both the EX and EX+DM (≥35%, P < 0.05) groups, but not in the DM and CON groups. The change in 1RM strength outcomes was higher in EX+DM compared to all other groups (53-78%, P < 0.01). There was an increase in resting plasma IL-10 concentration in EX+DM (88%), compared to all the other groups (P = 0.016). No other differences in systemic inflammatory cytokines were observed. There were no significant changes in all hormone concentrations measured among all groups. In conclusion, a high-protein dairy milk beverage providing additional protein did not further enhance the effects of PRT on outcomes of fat-free mass, power, or physical performance. However, there was a significant augmentative effect for high-protein dairy milk consumption on changes to maximal strength outcomes during PRT in healthy active older adults.
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Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Enalapril.
Verbeeck, RK, Kanfer, I, Löbenberg, R, Abrahamsson, B, Cristofoletti, R, Groot, DW, Langguth, P, Polli, JE, Parr, A, Shah, VP, et al
Journal of pharmaceutical sciences. 2017;(8):1933-1943
Abstract
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence testing for the marketing authorization of immediate-release, solid oral dosage forms containing enalapril maleate are reviewed. Enalapril, a prodrug, is hydrolyzed by carboxylesterases to the active angiotensin-converting enzyme inhibitor enalaprilat. Enalapril as the maleate salt is shown to be highly soluble, but only 60%-70% of an orally administered dose of enalapril is absorbed from the gastrointestinal tract into the enterocytes. Consequently, enalapril maleate is a Biopharmaceutics Classification System class III substance. Because in situ conversion of the maleate salt to the sodium salt is sometimes used in production of the finished drug product, not every enalapril maleate-labeled finished product actually contains the maleate salt. Enalapril is not considered to have a narrow therapeutic index. With this background, a biowaiver-based approval procedure for new generic products or after major revisions to existing products is deemed acceptable, provided the in vitro dissolution of both test and reference preparation is very rapid (at least 85% within 15 min at pH 1.2, 4.5, and 6.8). Additionally, the test and reference product must contain the identical active drug ingredient.
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Application of a Stable Isotope Approach to Evaluate Impact of Changes in Manufacturing Parameters for an Immediate-Release Tablet.
Parr, A, Badman, G, Bowen, CL, Coffin, M, Gupta, M, Jones, L, Kurtinecz, M, Naderer, O, Travis, E, Zhu, J, et al
Journal of clinical pharmacology. 2016;(7):801-5
Abstract
There is continued emphasis from the various worldwide regulatory agencies to ensure that the pharmaceutical industry fully understands the products they are developing. This emphasis is seen via development of quality-by-design (QbD) publications and guidelines generated by the International Committee on Harmonization. The challenge to meet these expectations is primarily associated with the generation of in vivo data (eg, pharmacokinetic data) that is resource intensive. A technique reducing the resources needed to generate this in vivo data permits a more extensive application of QbD principles. This paper presents the application of stable isotopes in pharmacokinetic studies. The data show that the use of stable isotopes can significantly reduce the number of subjects required for a study. This reduction in subjects thus translates into a significant reduction in resources and time needed to generate the required in vivo data to support QbD.