Effects of Protein Load Prior to the Main Meal of the Day: A Pilot Trial

Background: High protein diets increase satiety and may decrease energy intake. Many overweight people overeat in the evening. We hypothesized that ingesting protein prior to the evening meal may limit successive calorie intake and generate weight loss. Aims: To explore whether protein pre-load before the evening meal will lead to weight loss compared to eating as usual. Methods: 129 adults with a Body Mass Index (BMI) ≥25 reporting eating large evening meals were randomized to either consume a 20 g protein bar 30 minutes before their evening meal daily for two weeks (Protein pre-loading (PP) arm) or not (No protein pre-loading (NP) arm). Hunger ratings were recorded, immediately prior to each evening meal. Participants returned at the end of weeks one and two to provide their weight and rating of hunger and any changes in evening food consumption since baseline. Results: There was no significant difference in weight loss between the study arms (Week1 PP: -0.13 kg, [SD=0.74] vs. NP: -0.06 kg, [SD=0.75], not significant (NS); Week2 PP: +0.06 kg, [SD=0.82] vs. NP: -0.005 kg, [SD=0.82], NS). Participants in the PP arm reported less hunger before evening meals than those in the NP arm (Week1: 4.97 [SD=0.94] vs. 3.72[SD=0.65], p < .0011; Week2: 4.95 [SD=0.94] vs. 3.69[SD=0.71], p < .001). They also reported eating less at their evening meals (Week1: 2.59[SD=0.53] vs. 2.11[SD=0.54], p < .001; Week2: 2.63[SD=0.49] vs. 2.10[SD=0.50], p < .001). Conclusion: Consuming 20 g of protein before the evening meal reduced hunger and self-reported food intake in the evening, but had no effect on weight

Study protocol for a multicentre, randomised controlled trial to compare the use of the decellularised dermis allograft in addition to standard care versus standard care alone for the treatment of venous leg ulceration: DAVE trial.

INTRODUCTION Venous leg ulceration (VLU), the most common type of chronic ulcer, can be difficult to heal and is a major cause of morbidity and reduced quality of life. Although compression bandaging is the principal treatment, it is time-consuming and bandage application requires specific training. There is evidence that intervention on superficial venous incompetence can help ulcer healing and recurrence, but this is not accessible to all patients. Hence, new treatments are required to address these chronic wounds. One possible adjuvant treatment for VLU is human decellularised dermis (DCD), a type of skin graft derived from skin from deceased tissue donors. Although DCD has the potential to promote ulcer healing, there is a paucity of data for its use in patients with VLU. METHODS AND ANALYSIS This is a multicentre, parallel group, pragmatic randomised controlled trial. One hundred and ninety-six patients with VLU will be randomly assigned to receive either the DCD allograft in addition to standard care or standard care alone. The primary outcome is the proportion of participants with a healed index ulcer at 12 weeks post-randomisation in each treatment arm. Secondary outcomes include the time to index ulcer healing and the proportion of participants with a healed index ulcer at 12 months. Changes in quality of life scores and cost-effectiveness will also be assessed. All analyses will be carried out on an intention-to-treat (ITT) basis. A mixed-effects, logistic regression on the outcome of the proportion of those with the index ulcer healed at 12 weeks will be performed. Secondary outcomes will be assessed using various statistical models appropriate to the distribution and nature of these outcomes. ETHICS AND DISSEMINATION Ethical approval was granted by the Bloomsbury Research Ethics Committee (19/LO/1271). Findings will be published in a peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER ISRCTN21541209

Examining the benefit of graduated compression stockings in the prevention of hospital-associated venous thromboembolism in low-risk surgical patients: a multicentre cluster randomised controlled trial (PETS trial)

Introduction Hospital-acquired thrombosis (HAT) is defined as any venous thromboembolism (VTE)-related event during a hospital admission or occurring up to 90 days post discharge, and is associated with significant morbidity, mortality and healthcare-associated costs. Although surgery is an established risk factor for VTE, operations with a short hospital stay (&lt;48 hours) and that permit early ambulation are associated with a low risk of VTE. Many patients undergoing short-stay surgical procedures and who are at low risk of VTE are treated with graduated compression stockings (GCS). However, evidence for the use of GCS in VTE prevention for this cohort is poor.Methods and analysis A multicentre, cluster randomised controlled trial which aims to determine whether GCS are superior in comparison to no GCS in the prevention of VTE for surgical patients undergoing short-stay procedures assessed to be at low risk of VTE. A total of 50 sites (21 472 participants) will be randomised to either intervention (GCS) or control (no GCS). Adult participants (18–59 years) who undergo short-stay surgical procedures and are assessed as low risk of VTE will be included in the study. Participants will provide consent to be contacted for follow-up at 7-days and 90-days postsurgical procedure. The primary outcome is the rate of symptomatic VTE, that is, deep vein thrombosis or pulmonary embolism during admission or within 90 days. Secondary outcomes include healthcare costs and changes in quality of life. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, measured at an individual level, using hierarchical (multilevel) logistic regression.Ethics and dissemination Ethical approval was granted by the Camden and Kings Cross Research Ethics Committee (22/LO/0390). Findings will be published in a peer-reviewed journal and presented at national and international conferences.Trial registration number ISRCTN13908683

Examining the benefit of graduated compression stockings in the prevention of hospital-associated venous thromboembolism in low-risk surgical patients: a multicentre cluster randomised controlled trial (PETS trial)

INTRODUCTION: Hospital-acquired thrombosis (HAT) is defined as any venous thromboembolism (VTE)-related event during a hospital admission or occurring up to 90 days post discharge, and is associated with significant morbidity, mortality and healthcare-associated costs. Although surgery is an established risk factor for VTE, operations with a short hospital stay (&lt;48 hours) and that permit early ambulation are associated with a low risk of VTE. Many patients undergoing short-stay surgical procedures and who are at low risk of VTE are treated with graduated compression stockings (GCS). However, evidence for the use of GCS in VTE prevention for this cohort is poor.METHODS AND ANALYSIS: A multicentre, cluster randomised controlled trial which aims to determine whether GCS are superior in comparison to no GCS in the prevention of VTE for surgical patients undergoing short-stay procedures assessed to be at low risk of VTE. A total of 50 sites (21 472 participants) will be randomised to either intervention (GCS) or control (no GCS). Adult participants (18-59 years) who undergo short-stay surgical procedures and are assessed as low risk of VTE will be included in the study. Participants will provide consent to be contacted for follow-up at 7-days and 90-days postsurgical procedure. The primary outcome is the rate of symptomatic VTE, that is, deep vein thrombosis or pulmonary embolism during admission or within 90 days. Secondary outcomes include healthcare costs and changes in quality of life. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, measured at an individual level, using hierarchical (multilevel) logistic regression.ETHICS AND DISSEMINATION: Ethical approval was granted by the Camden and Kings Cross Research Ethics Committee (22/LO/0390). Findings will be published in a peer-reviewed journal and presented at national and international conferences.TRIAL REGISTRATION NUMBER: ISRCTN13908683.</p