Clinical trial NCT06398340: Identifying Wearable Biomarkers to Monitor Dietary Intake
Official title: Identifying Physiological Biomarkers for Monitoring Dietary Behaviours
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Energy Intake
Metabolism
Digestion
Wearables
Dietary Intake Assessment
Healthy Volunteers
Blood Glucose
Keywords: Dietary intake monitoring
wearable sensors
digital health
blood glucose
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Background: Measuring what people eat is a challenge in nutrition research. Traditional methods, like food diaries, rely on self-reporting of individuals, and suffer from poor accuracy and recall bias.

Aims: This project aims to identify physiological biomarkers related to food and energy intake, which may be used to develop an objective tool to estimate individuals' food intake in future. Eating behaviours are accompanied by significant physiological changes such as skin temperature, blood oxygen saturation, pulse rate etc. The investigators intend to investigate whether monitoring these physiological changes can help us estimate eating behaviour, such as meal size, eating speed, and duration of meals.

Study design: Ten healthy adults will be invited for two study visits at NIHR Imperial Clinical Research Facility. Each visit will last for approximately 2 hr. They will consume a high- and low-calorie meal designed by nutritional researchers in a randomised order. During eating events, the investigators will track their physiological changes via a bedside monitor and wearable sensors. Blood samples will be taken from participants to measure their glycaemic response. Associations between energy load, glycaemic response, and physiological changes will be investigated. Our findings may promote an accelerated development of a wearable tool for dietary assessment in future.

Detailed description: 1 Participants

10 healthy male and female participants. This is a pilot study in a new area and therefore a formal power calculation is not possible.

2. Recruitment

Participants will be recruited from existing healthy volunteer databases and by advertisement in public places. Adverts may be placed in newspapers and put up in public buildings. A contact number on the advert will enable potential participants to contact the research team at Imperial College London. Participation in the study will be entirely voluntary. No undue influence will be exerted by the researchers. Participants will be free to withdraw from the study at any time.

3 Pre-Screening Questionnaire

A pre-screening questionnaire considering the inclusion and exclusion criteria will be completed to establish eligibility. For subjects who complete the questionnaire but do not continue to participate, their data will not be saved.

4 Informed Consent

All participants will sign informed consent before starting the study (at the beginning of the 1st main study visit).

5 Main Study Visits

Ten healthy subjects will attend two study visits at National Institute for Health and Care Research (NIHR) Imperial College London Clinical Research Facility (post code: W12 0NN, London, UK). The participants will consume a high- and low-calorie meal designed by nutritional researchers, in a randomised order. Randomization will be performed using the sealed envelope website by an independent researcher (i.e., not linked to the study). During eating events, physiological changes such as skin temperature, blood oxygen saturation, pulse rate etc and eating movements will be measured via a bedside monitor and non-invasive, wearable sensors. Blood samples will be taken at pre-determined time-points, starting 5 minutes before the meal and lasting for 60 minutes postprandially (at -5, +15, +30, +45, +60 min ). A total of 25 ml blood will be taken per visit.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Age between 18-65 years (inclusive)
* Body mass index (BMI) of 18-30 kg/m2
* Willingness and ability to give written informed consent.
* Willingness and ability to understand, to participate and to comply with the study requirements

Exclusion Criteria:

* Outside of specified age and BMI range
* Chronic medical conditions including for eating disorders, diabetes, obesity, hypertension, cancer, acute infectious disease, renal disease, cardiovascular disease, and chronic gastrointestinal condition.
* Taking part in another research study or donating any blood in the last 3 months

Primary outcomes:
measure: Changes of heart rate associated with dietary events (pre- vs post- meal).
timeFrame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
measure: Changes of blood pressure associated with dietary events (pre- vs post- meal).
timeFrame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
measure: Changes of oxygen saturation associated with dietary events (pre- vs post- meal).
timeFrame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
measure: Changes of skin temperature associated with dietary events (pre- vs post- meal).
timeFrame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
measure: Changes of hand movements associated with dietary events (pre- vs post- meal).
timeFrame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Secondary outcomes:
measure: Changes of heart rate associated with energy intake (high vs. low calorie meals)
timeFrame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
measure: Changes of blood pressure associated with energy intake (high vs. low calorie meals)
timeFrame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
measure: Changes of heart oxygen saturation associated with energy intake (high vs. low calorie meals)
timeFrame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
measure: Changes of skin temperature associated with energy intake (high vs. low calorie meals)
timeFrame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
measure: Changes of hand movements associated with energy intake (high vs. low calorie meals)
timeFrame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
measure: Vital signs associated with blood glucose, insulin and hormonal levels
timeFrame: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: NIHR Imperial College London Clinical Research Facility
Study officials:
affiliation: Nutrition Research Section, Imperial College London
name: Mingzhu Cai, PhD
role: STUDY_CHAIR
affiliation: Department of Electrical and Electronic Engineering, Imperial College London
name: Mayue Shi, PhD
role: PRINCIPAL_INVESTIGATOR
References: