Effects of whey protein plus vitamin D supplementation combined with progressive resistance training on glycaemic control, body composition, muscle function and cardiometabolic risk factors in middle-aged and older overweight/obese adults with type 2 diabetes: A 24-week randomized controlled trial.

AIM: To determine the effect of whey protein plus vitamin D supplementation combined with progressive resistance training (PRT) on glycaemic control, body composition, muscle function and cardiometabolic risk factors in middle-aged and older adults with type 2 diabetes (T2D). MATERIALS AND METHODS: In this 24-week, randomized controlled trial, 198 overweight/obese adults (aged 50-75 years) with T2D undertook PRT (2-3 days/week) with random allocation to whey protein (20 g each morning plus 20 g postexercise) plus vitamin D3 (2000 IU/day) (PRT + ProD, n = 98) or no supplementation (PRT, n = 100). Primary outcomes were HbA1c and homeostatic model assessment-2 of insulin resistance (HOMA2-IR). Secondary endpoints included fasting plasma glucose (FPG), body composition, muscle strength, physical function, blood pressure, blood lipids and inflammatory markers. RESULTS: At 24 weeks, supplementation did not enhance the effects of PRT on HbA1c (mean absolute change: PRT + ProD -0.10% [95% CI, -0.24%, 0.05%] vs. PRT -0.17% [95% CI, -0.32%, -0.03%], p = .322) or HOMA2-IR (PRT + ProD -0.12 [95% CI, -0.27, 0.03] vs. PRT -0.03 [95% CI, -0.14, 0.09], p = .370). There were also no significant between-group differences for the mean changes in the secondary outcomes, except that FPG improved in PRT versus PRT + ProD (net difference, 0.6 mmol/L [95% CI, 0.1, 1.0], P = .018), while interleukin IL-10 (61% [95% CI 31%, 92%], P < .001), tumour necrosis factor-α (16% [95% CI, 3%, 29%], p = .015) and 30-s sit-to-stand performance (number, 1.0 [95% CI, -0.05, 1.5], p = .047) increased in PRT + ProD versus PRT. CONCLUSIONS: In older overweight/obese adults with T2D, daily whey protein plus vitamin D supplementation did not augment the effects of PRT on measures of glycaemic control, body composition, muscle strength or cardiometabolic risk factors.

Nutrition management of obese critically ill adults: A survey of critical care dietitians in Australia and New Zealand.

BACKGROUND: Guideline recommendations for nutrition therapy in critically ill obese adults are inconsistent. This study aimed to describe how dietitians working in an intensive care unit (ICU) in Australia and New Zealand (ANZ) approach managing the nutritional needs of an obese, critically ill adult. METHODS: Invitations to participate were via personal email communication. The survey was also disseminated through a research email list and a dietitian-based newsletter. The multiple-choice case-based survey consisted of 12 questions relating to nutrition prescription and were based on international nutrition guideline recommendations including (i) weight used in energy and protein predictive equations; (ii) energy and protein prescription at ICU admission and day 7, (iii) commencement of enteral nutrition, and; (iv) use of supplemental protein. Data are reported as n (%). RESULTS: Sixty-three dietitians participated in the survey. Most commonly, adjusted body weight calculated as 'weight at BMI 25 kg/m2 + 25% excess weight' was used in equations to guide energy (44 respondents, 70%) and protein (39 respondents, 62%) prescription. At day 1, energy and protein prescription was most commonly based on the European Society of Parenteral and Enteral Nutrition (ESPEN) guideline recommendation of 20-25 kcal/kg (39 respondents, 62%) and 1.3 g protein/kg adjusted body weight (36 respondents, 57%). Thirteen (21%) respondents had an indirect calorimetry device in their ICU to measure energy expenditure. On day 7, the ESPEN recommendations were again the most common method used for prescribing energy (30 respondents, 48%) and protein (23 respondents. 48%) needs. Thirty-eight dietitians (60%) reported they would use early supplemental protein to meet protein requirements. CONCLUSIONS: ICU dietitians in ANZ who responded to the survey most commonly report using the ESPEN ICU guideline recommendations (20-25 kcal/kg and 1.3 g protein/kg adjusted body weight) to guide nutrition prescription in an obese critically ill adult. Prospective studies are required to confirm these findings.

Divergent shifts in lipid mediator profile following supplementation with n-3 docosapentaenoic acid and eicosapentaenoic acid.

In contrast to the well-characterized effects of specialized proresolving lipid mediators (SPMs) derived from eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), little is known about the metabolic fate of the intermediary long-chain (LC) n-3 polyunsaturated fatty acid (PUFA) docosapentaenoic acid (DPA). In this double blind crossover study, shifts in circulating levels of n-3 and n-6 PUFA-derived bioactive lipid mediators were quantified by an unbiased liquid chromatography-tandem mass spectrometry lipidomic approach. Plasma was obtained from human subjects before and after 7 d of supplementation with pure n-3 DPA, n-3 EPA or placebo (olive oil). DPA supplementation increased the SPM resolvin D5n-3DPA (RvD5n-3DPA) and maresin (MaR)-1, the DHA vicinal diol 19,20-dihydroxy-DPA and n-6 PUFA derived 15-keto-PG E2 (15-keto-PGE2). EPA supplementation had no effect on any plasma DPA or DHA derived mediators, but markedly elevated monohydroxy-eicosapentaenoic acids (HEPEs), including the e-series resolvin (RvE) precursor 18-HEPE; effects not observed with DPA supplementation. These data show that dietary n-3 DPA and EPA have highly divergent effects on human lipid mediator profile, with no overlap in PUFA metabolites formed. The recently uncovered biologic activity of n-3 DPA docosanoids and their marked modulation by dietary DPA intake reveals a unique and specific role of n-3 DPA in human physiology.-Markworth, J. F., Kaur, G., Miller, E. G., Larsen, A. E., Sinclair, A. J., Maddipati, K. R., Cameron-Smith, D. Divergent shifts in lipid mediator profile following supplementation with n-3 docosapentaenoic acid and eicosapentaenoic acid.

Effects of progressive resistance training and weight loss versus weight loss alone on inflammatory and endothelial biomarkers in older adults with type 2 diabetes.

PURPOSE: Type 2 diabetes has been associated with an increase in inflammatory and endothelial biomarkers, which are associated with an increased risk of cardiovascular disease and diabetes-related complications. This study examined the effects of high-intensity progressive resistance training (PRT) with moderate weight loss (WL) versus WL alone on inflammatory and endothelial biomarkers in older overweight adults with type 2 diabetes. METHODS: This was a 12-month randomized controlled trial in which 36 inactive, overweight adults aged 60-80 years with poorly controlled type 2 diabetes were randomized to 6 months of supervised PRT + WL or stretching (sham) exercise plus WL followed by 6 months of home-training without dietary modification. Fasted blood samples were collected at baseline and subsequent 3-month intervals with the following inflammatory [interleukin (IL)-10, IL-6, tumor necrosis factor (TNF)-α, adiponectin] and endothelial markers [resistin and intercellular adhesion molecule (ICAM)-1)] assessed. RESULTS: No significant within-group changes or between-group differences were detected for any inflammatory or endothelial biomarker following the 6-month supervised exercise and WL phase. There was a greater reduction in IL-10 at 9 months in the PRT + WL relative to WL group (P = 0.033). There was also a greater reduction in TNF-α at 9 and 12 months in the PRT + WL relative to WL group (P = 0.026 and P = 0.024, respectively). Serum adiponectin increased in the PRT + WL relative to WL group after 12 months (P = 0.036). All results were adjusted for baseline values, age, weight, sex, diabetes duration, medication use and any change in medication. CONCLUSIONS: Long-term participation in PRT, independent of change in weight, can result in some improvements in certain inflammatory markers in older overweight adults with type 2 diabetes.

How do guideline recommended energy targets compare with measured energy expenditure in critically ill adults with obesity: A systematic literature review.

BACKGROUND: Critically ill patients with obesity have unique and complex nutritional needs, with clinical practice guidelines conflicting regarding recommended energy targets. The aim of this systematic review was to 1) describe measured resting energy expenditure (mREE) reported in the literature and; 2) compare mREE to predicted energy targets using the European (ESPEN) and American (ASPEN) guideline recommendations when indirect calorimetry is not available in critically ill patients with obesity. METHODS: The protocol was registered apriori and literature was searched until 17th March, 2022. Original studies were included if they reported mREE using indirect calorimetry in critically ill patients with obesity (BMI≥30 kg/m2). Group-level mREE data was reported as per the primary publication using mean ± standard deviation or median [interquartile range]. Where individual patient data was available, Bland-Altman analysis was used to assess mean bias (95% limits of agreement) between guideline recommendations and mREE targets (i.e. ASPEN for BMI 30-50, 11-14 kcal/kg actual weight compared to 70% mREE and ESPEN 20-25 kcal/kg adjusted weight compared to 100% mREE). Accuracy was assessed by the percentage (%) of estimates within ±10% of mREE targets. RESULTS: After searching 8019 articles, 24 studies were included. mREE ranged from 1607 ± 385 to 2919 [2318-3362]kcal and 12-32kcal/actual body weight. For the ASPEN recommendations of 11-14 kcal/kg, a mean bias of -18% (-50% to +13%) and 4% (-36% to +44%) was observed, respectively (n = 104). For the ESPEN recommendations 20-25 kcal/kg, a bias of -22% (-51% to +7%) and -4% (-43% to +34%), was observed, respectively (n = 114). The guideline recommendations were able to accurately predict mREE targets on 30%-39% occasions (11-14 kcal/kg actual) and 15%-45% occasions (20-25 kcal/kg adjusted), for ASPEN and ESPEN recommendations, respectively. CONCLUSIONS: Measured energy expenditure in critically ill patients with obesity is variable. Energy targets generated using predictive equations recommended in both the ASPEN and ESPEN clinical guidelines have poor agreement with mREE and are frequently not able to accurately predict within ±10% of mREE, most commonly underestimating energy needs.

Protocol summary and statistical analysis plan for Intensive Nutrition Therapy comparEd to usual care iN criTically ill adults (INTENT): a phase II randomised controlled trial.

INTRODUCTION: It is plausible that a longer duration of nutrition intervention may have a greater impact on clinical and patient-centred outcomes. The Intensive Nutrition care Therapy comparEd to usual care iN criTically ill adults (INTENT) trial will determine if a whole hospital nutrition intervention is feasible and will deliver more total energy compared with usual care in critically ill patients with at least one organ system failure. METHODS AND ANALYSIS: This study is a prospective, multicentre, unblinded, parallel-group, phase II randomised controlled trial (RCT) conducted in 23 hospitals in Australia and New Zealand. Mechanically ventilated critically ill adult patients with at least one organ failure who have been in intensive care unit (ICU) for 72-120 hours and meet all of the inclusion and none of the exclusion criteria will be randomised to receive either intensive or usual nutrition care. INTENT started recruitment in October 2018 and a sample size of 240 participants is anticipated to be recruited in 2022. The study period is from randomisation to hospital discharge or study day 28, whichever occurs first, and the primary outcome is daily energy delivery from nutrition therapy. Secondary outcomes include daily energy and protein delivery during ICU and in the post-ICU period, duration of ventilation, ventilator-free days, total bloodstream infection rate and length of hospital stay. All other outcomes are considered tertiary and results will be analysed on an intention-to-treat basis. ETHICS AND DISSEMINATION: Ethics approval has been received in Australia (Alfred Hospital Ethics Committee (HREC/18/Alfred/101) and Human Research Ethics Committee of the Northern Territory Department of Health (2019-3372)) and New Zealand (Northern A Health and Disability Ethics Committee (18/NTA/222). Results will be disseminated in an international peer-reviewed journal(s), at scientific meetings and via social media. TRIAL REGISTRATION NUMBER: NCT03292237.

Recruitment of older adults with type 2 diabetes into a community-based exercise and nutrition randomised controlled trial.

BACKGROUND: Recruitment of participants into long-term community-based lifestyle intervention trials, particularly adults with a chronic disease, is often slow and challenging. Currently there is limited data on successful recruitment strategies suitable for older adults with type 2 diabetes into community-based exercise and nutrition programs, and no information on cost estimates associated with such recruitment. The aim of this report is to describe the recruitment strategies used and the success of each approach in recruiting older adults with type 2 diabetes into a 6-month community-based exercise and nutritional supplementation randomised controlled trial (RCT). A secondary aim is to assess the costs associated with the recruitment methods used. METHODS: The Resistance Exercise, Vitamin D and Muscle Protein Intervention Trial (REVAMP-IT) for type 2 diabetes is a 24-week RCT targeting 202 adults with type 2 diabetes which is designed to evaluate whether post-exercise ingestion of a whey- protein and vitamin D-enriched drink can enhance the effects of progressive resistance training (PRT) on glycaemic control, body composition and cardiometabolic health. Participants in this trial were randomly allocated to either: (1) the Lift for Life® community-based PRT program combined with additional whey protein and vitamin D, or (2) the Lift for Life® PRT program alone. Recruitment strategies included state and local newspaper and radio advertisements, targeted mail-outs, doctor and allied health referrals, community presentations, web-based media and word of mouth. The number of expressions of interest, participants screened and included in the trial, and how they first heard about the study were recorded by research staff during the screening process. Reasons for ineligibility or non-participation in the trial were also recorded as was the cost of each recruitment method used. RESULTS: A total of 1157 expressions of interest were received over a 21-month recruitment period. Overall 959 (83 %) individuals were screened and found to be ineligible for the trial or chose not to participate or could not be contacted further following their initial enquiry. As a result, 198 participants were randomised to the 24-week intervention. The most effective recruitment strategies were targeted mass mail-outs (39 % of the total participant sample), state (27 %) and local (14 %) print media. In total recruitment expenditure was AUD$40,421, which equated to AUD$35 per enquiry and AUD$204 per eligible participant. Targeted mail-outs and state print media were the most expensive strategies each accounting for 38 % of total expenditure. CONCLUSIONS: To recruit around 200 older adults with type 2 diabetes into a community-based lifestyle intervention trial in a timely manner, it is important to ensure that an adequate budget is allocated to recruitment as targeted mail-outs and state/local print media were the most costly but effective strategies. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry reference ACTRN12613000592741 . Registered on 27 May 2013.

The effects of progressive resistance training combined with a whey-protein drink and vitamin D supplementation on glycaemic control, body composition and cardiometabolic risk factors in older adults with type 2 diabetes: study protocol for a randomized controlled trial.

BACKGROUND: While physical activity, energy restriction and weight loss are the cornerstone of type 2 diabetes management, less emphasis is placed on optimizing skeletal muscle mass. As muscle is the largest mass of insulin-sensitive tissue and the predominant reservoir for glucose disposal, there is a need to develop safe and effective evidence-based, lifestyle management strategies that optimize muscle mass as well as improve glycaemic control and cardiometabolic risk factors in people with this disease, particularly older adults who experience accelerated muscle loss. METHODS/DESIGN: Using a two-arm randomized controlled trial, this 6-month study builds upon the community-based progressive resistance training (PRT) programme Lift for Life® to evaluate whether ingestion of a whey-protein drink combined with vitamin D supplementation can enhance the effects of PRT on glycaemic control, body composition and cardiometabolic health in older adults with type 2 diabetes. Approximately 200 adults aged 50 to 75 years with type 2 diabetes, treated with either diet alone or oral hypoglycaemic agents (not insulin), will be recruited. All participants will be asked to participate in a structured, supervised PRT programme based on the Lift for Life® programme structure, and randomly allocated to receive a whey-protein drink (20 g daily of whey-protein plus 20 g after each PRT session) plus vitamin D supplements (2000 IU/day), or no additional powder and supplements. The primary outcome measures to be collected at baseline, 3 and 6 months will be glycated haemoglobin (HbA1c) and insulin sensitivity (homeostatic model assessment). Secondary outcomes will include changes in: muscle mass, size and intramuscular fat; fat mass; muscle strength and function; blood pressure; levels of lipids, adipokines and inflammatory markers, serum insulin-like growth factor-1 and 25-hydroxyvitamin D; renal function; diabetes medication; health-related quality of life, and cognitive function. DISCUSSION: The findings from this study will provide new evidence on whether increased dietary protein achieved through the ingestion of a whey-protein drink combined with vitamin D supplementation can enhance the effects of PRT on glycaemic control, muscle mass and size, and cardiometabolic risk factors in older adults with type 2 diabetes. TRIAL REGISTRATION: Australian New Zealand Clinical Trials ACTRN12613000592741.