BackgroundCritically ill patients are subject to severe skeletal muscle wasting during intensive care unit (ICU) stay, resulting in impaired short- and long-term functional outcomes and health-related quality of life. Increased protein provision may improve functional outcomes in ICU patients by attenuating skeletal muscle breakdown. Supporting evidence is limited however and results in great variety in recommended protein targets.MethodsThe PRECISe trial is an investigator-initiated, bi-national, multi-center, quadruple-blinded randomized controlled trial with a parallel group design. In 935 patients, we will compare provision of isocaloric enteral nutrition with either a standard or high protein content, providing 1.3 or 2.0 g of protein/kg/day, respectively, when fed on target. All unplanned ICU admissions with initiation of invasive mechanical ventilation within 24 h of admission and an expected stay on ventilator support of at least 3 days are eligible. The study is designed to assess the effect of the intervention on functional recovery at 1, 3, and 6 months following ICU admission, including health-related quality of life, measures of muscle strength, physical function, and mental health. The primary endpoint of the trial is health-related quality of life as measured by the Euro-QoL-5D-5-level questionnaire Health Utility Score. Overall between-group differences will be assessed over the three time points using linear mixed-effects models.DiscussionThe PRECISe trial will evaluate the effect of protein on functional recovery including both patient-centered and muscle-related outcomes.Trial registrationClinicalTrials.gov Identifier: NCT04633421. Registered on November 18, 2020. First patient in (FPI) on November 19, 2020. Expected last patient last visit (LPLV) in October 2023.
MULTIFILE
Background & aims: High protein delivery during early critical illness is associated with lower mortality, while energy overfeeding is associated with higher mortality. Protein-to-energy ratios of traditional enteral formulae are sometimes too low to reach protein targets without energy overfeeding. This prospective feasibility study aimed to evaluate the ability of a new enteral formula with a high protein-to-energy ratio to achieve the desired protein target while avoiding energy overfeeding.Methods: Mechanically ventilated non-septic patients received the high protein-to-energy ratio nutrition during the first 4 days of ICU stay (n = 20). Nutritional prescription was 90% of measured energy expenditure. Primary endpoint was the percentage of patients reaching a protein target of ≥1.2 g/kg ideal body weight on day 4. Other endpoints included a comparison of nutritional intake to matched historic controls and the response of plasma amino acid concentrations. Safety endpoints were gastro-intestinal tolerance and plasma urea concentrations. Results: Nineteen (95%) patients reached the protein intake target of ≥1.2 g/kg ideal body weight on day 4, compared to 65% in historic controls (p = 0.024). Mean plasma concentrations of all essential amino acids increased significantly from baseline to day 4. Predefined gastro-intestinal tolerance was good, but unexplained foul smelling diarrhoea occurred in two patients. In one patient plasma urea increased unrelated to acute kidney injury. Conclusions: In selected non-septic patients tolerating enteral nutrition, recommended protein targets can be achieved without energy overfeeding using a new high protein-to-energy ratio enteral nutrition.
MULTIFILE
Digitally supported dietary counselling may be helpful in increasing the protein intake in combined exercise and nutritional interventions in community-dwelling older adults. To study the effect of this approach, 212 older adults (72.2 ± 6.3 years) were randomised in three groups: control, exercise, or exercise plus dietary counselling. The dietary counselling during the 6-month intervention was a blended approach of face-to-face contacts and videoconferencing, and it was discontinued for a 6-month follow-up. Dietary protein intake, sources, product groups, resulting amino acid intake, and intake per eating occasion were assessed by a 3-day dietary record. The dietary counselling group was able to increase the protein intake by 32% at 6 months, and the intake remained 16% increased at 12 months. Protein intake mainly consisted of animal protein sources: dairy products, followed by fish and meat. This resulted in significantly more intake of essential amino acids, including leucine. The protein intake was distributed evenly over the day, resulting in more meals that reached the protein and leucine targets. Digitally supported dietary counselling was effective in increasing protein intake both per meal and per day in a lifestyle intervention in community-dwelling older adults. This was predominantly achieved by consuming more animal protein sources, particularly dairy products, and especially during breakfast and lunch.
MULTIFILE
While the creation of an energy deficit (ED) is required for weight loss, it is well documented that actual weight loss is generally lower than what expected based on the initially imposed ED, a result of adaptive mechanisms that are oppose to initial ED to result in energy balance at a lower set-point. In addition to leading to plateauing weight loss, these adaptive responses have also been implicated in weight regain and weight cycling (add consequences). Adaptions occur both on the intake side, leading to a hyperphagic state in which food intake is favored (elevated levels of hunger, appetite, cravings etc.), as well as on the expenditure side, as adaptive thermogenesis reduces energy expenditure through compensatory reductions in resting metabolic rate (RMR), non-exercise activity expenditure (NEAT) and the thermic effect of food (TEF). Two strategies that have been utilized to improve weight loss outcomes include increasing dietary protein content and increasing energy flux during weight loss. Preliminary data from our group and others demonstrate that both approaches - especially when combined - have the capacity to reduce the hyperphagic response and attenuate reductions in energy expenditure, thereby minimizing the adaptive mechanisms implicated in plateauing weight loss, weight regain and weight cycling. Past research has largely focused on one specific component of energy balance (e.g. hunger or RMR) rather than assessing the impact of these strategies on all components of energy balance. Given that all components of energy balance are strongly connected with each other and therefore can potentially negate beneficial impacts on one specific component, the primary objective of this application is to use a comprehensive approach that integrates all components of energy balance to quantify the changes in response to a high protein and high energy flux, alone and in combination, during weight loss (Fig 1). Our central hypothesis is that a combination of high protein intake and high energy flux will be most effective at minimizing both metabolic and behavioral adaptations in several components of energy balance such that the hyperphagic state and adaptive thermogenesis are attenuated to lead to superior weight loss results and long-term weight maintenance.