Multiple Physiological and Behavioural Parameters Identification for Dietary Monitoring Using Wearable Sensors: A Feasibility Study Protocol

IntroductionTraditional dietary intake assessment is labour- and time-consuming and prone to inaccuracies and biases. Emerging wearable sensing technology may offer a promising solution. This protocol paper describes a study investigating the physiological responses to energy intake utilising a customised wearable multi-sensor band, which is specifically designed to monitor multiple physiological and behavioural responses related to eating and digestion events for dietary monitoring. Methods and AnalysisThis study will recruit 10 healthy volunteers from databases and public advertisements, with informed consent required prior to participation. Participants will attend two main study visits at a clinical research facility, consuming pre-defined high- and low-calorie meals in a randomised order. Wearable sensors will be worn throughout the eating episodes to track hand-to-mouth movements and physiological changes, including skin temperature (Tsk), heart rate (HR), and oxygen saturation (SpO2). These sensor readings will be validated against a traditional bedside monitor which additionally measures blood pressure. Blood samples will be collected via intravenous cannula to measure blood glucose, insulin, and hormone levels. Relationship between eating episodes (e.g., occurrence, duration, use of cutlery, high- vs. low-calorie) with hand movement patterns, as well as physiological and blood biochemical responses, will be analysed. Ethics and DisseminationEthical approval has been granted by London - Westminster Research Ethics Committee. REC reference: 23/PR/1379. Written informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed journals, conferences, and seminar presentations. Protocol V.5. Protocol date: 16 January 2024. Trial Registration NumberNCT06398340. Strengths and Limitations of This StudyO_LIThis study is the first trial to develop an objective and reproducible wearable dietary monitoring tool by tracking physiological and motor changes. The novelty of this tool is the ability to estimate food intake without capturing food images which raises fewer privacy concerns compared to the existing technologies in this field. C_LIO_LIThe comprehensive monitoring of various physiological and behavioural parameters provides a thorough evaluation of the relationship between eating behaviour and physiological changes, with validation through bedside monitors. C_LIO_LIThe exploratory outcomes of the study offer the opportunity to identify physiological markers that can be tracked by a wearable device to predict postprandial blood glucose and hormone levels that have implications for glycaemic control and appetite regulation. C_LIO_LIThis study recruits healthy subjects, and investigations should be expanded to include disease groups such as obese individuals who may have different cardiac outputs. C_LIO_LIThe study will be conducted under a controlled environment and requires further investigations in real-life settings. C_LI