Feasibility of a novel nutritional supplement for surgical patients
Research type
Research Study
Full title
Investigating the acceptability and feasibility of a novel nutritional supplement on patients undergoing different treatment stages for cancer and emergency disease presentations
IRAS ID
280595
Contact name
Dermot Burke
Contact email
Sponsor organisation
University of Leeds
ISRCTN Number
ISRCTN83283595
Duration of Study in the UK
0 years, 1 months, 26 days
Research summary
Research Summary:
We aim to investigate the feasibility and acceptability of novel nutritional supplementation in bowel/pancreatic cancer and patients who have received emergency or planned surgery. Surgery is a common type of treatment in both bowel and pancreatic cancer patients alongside other forms of treatment such as chemotherapy. Nevertheless, side effects of such treatments may also include loss of muscle mass and suppression of appetite. These patients also tend to be over 60 years old, at high risk of undernourishment and with loss of muscle mass. Thus, further suppression of appetite will negatively impact upon nutritional intakes known to exacerbate losses in muscle mass, which is a contributing factor to frailty. Taking also into account that frailty is highly prevalent in older surgical patients, any attempts to address nutritional deficiencies may positively influence muscle mass and ultimately improve surgical outcomes and quality of life. Enhancing muscle mass requires consumption of high amounts of protein and food (energy intake) in general. However, consumption of whole protein is known to suppress appetite Human food contains meals high in protein will readily suppress appetite, However, medically designed nutritional supplements, that are in common clinical use, are also based around whole proteins. Thus, the ability to eat food and nutritious supplements together is compromised. We have developed amino acid -based nutritional prototypes that are superior to high quality protein quality supplements. We have demonstrated that older women-also suffering from nutritional deficiencies and muscle weakness-can consume our nutritional supplements before or alongside a breakfast meal without reducing their energy intake. Therefore, supplements can be taken alongside meals to increase both energy and protein intake.
Patients with bowel and pancreatic cancer or frail patients presenting as emergencies, could benefit hugely by such a supplementation regime. However, before we conduct any clinical trials, we need to conduct several feasibility studies. Our key aims will be to investigate whether patients at different stages of treatment can take the supplements and whether the appetite responses are like those we have observed in older people.Lay summary of study results:
Older adults often experience deficiencies in dietary intake. Essential amino acids (EAA) may help optimise protein intake without suppressing appetite, yet their acceptability remains unclear. This study explored the impact of an EAA gel supplement on appetite, palatability, and adherence in older colorectal surgical patients.The feasibility study had three patient groups (n=22): preoperative (n=6) and postoperative colorectal cancer (n=8), and emergency surgery (n=8). Preoperative patients’ appetite, energy, and protein intake were assessed following consumption of an EAA supplement during a breakfast using an acute crossover design. In all groups, palatability was assessed post-supplement consumption.
Patients consuming the supplements alongside breakfast had significant higher energy and protein intake:, energy intake was 523.1 kcal (±137.2) kcal and protein intake was 27.7 g (±6.8) in the intervention, compared to 359.1 kcal (±66.8) kcal and 17.8 g (±2.4) in the control (p=0.105 energy intake; p=0.104 protein intake). Elective patients rated the supplement more favourably (p=0.03 taste, p=0.05 palatability) and adhered to the regime better.
The main findings were that in the pre-operative group, EAA supplementation increased protein and energy intake without affecting appetite. Elective patients found the supplement more palatable than emergency patients, suggesting that taste perception may influence acceptability. Enhancing supplement palatability may play a role in perioperative recovery particularly for emergency patients.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
21/YH/0054
Date of REC Opinion
4 Mar 2021
REC opinion
Favourable Opinion