Identifying Wearable Biomarkers to Monitor Dietary Intake

NCT ID: NCT06398340

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-19
• Study Completion Date: 2025-07-31

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.

Conditions

Energy Intake; Metabolism; Digestion; Wearables; Dietary Intake Assessment; Healthy Volunteers; Blood Glucose

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

High Calorie, Then Low Calorie

Subjects will receive an unhealthy meal that against the healthy eating guidelines. After a washout period of at least 24hours, subjects will receive a balanced diet that meets healthy eating guidelines.

Group Type: EXPERIMENTAL

High Calorie Meal Intervention

Intervention Type: OTHER

Subjects will receive a unhealthy meal high in calorie, sugar and fat

Low Calorie Meal Intervention

Intervention Type: OTHER

Subjects will receive a healthy meal with balanced macronutrient, high in vegetables and dietary fibre

Low Calorie, Then High Calorie

Subjects will receive a balanced diet that meets healthy eating guidelines. After a washout period of at least 24hours, subjects will receive an unhealthy meal that against the healthy eating guidelines

Group Type: EXPERIMENTAL

High Calorie Meal Intervention

Intervention Type: OTHER

Subjects will receive a unhealthy meal high in calorie, sugar and fat

Low Calorie Meal Intervention

Intervention Type: OTHER

Subjects will receive a healthy meal with balanced macronutrient, high in vegetables and dietary fibre

Interventions

High Calorie Meal Intervention

Subjects will receive a unhealthy meal high in calorie, sugar and fat

Intervention Type: OTHER

Low Calorie Meal Intervention

Subjects will receive a healthy meal with balanced macronutrient, high in vegetables and dietary fibre

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mingzhu Cai, PhD

Role: STUDY_CHAIR

Nutrition Research Section, Imperial College London

Mayue Shi, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Electrical and Electronic Engineering, Imperial College London

Locations

NIHR Imperial College London Clinical Research Facility

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Mingzhu Cai, PhD

Role: CONTACT

m.cai18@imperial.ac.uk

+44(0)7395757128

Facility Contacts

Mingzhu Cai, PhD

Role: primary

m.cai18@imperial.ac.uk

+44(0)7395757128

References

Shi M, Zhou J, Cai M. Multiple physiological and behavioural parameters identification for dietary monitoring using wearable sensors: a study protocol. BMC Nutr. 2025 Oct 6;11(1):183. doi: 10.1186/s40795-025-01168-1.

Reference Type: DERIVED

PMID: 41053911 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

23HH8489

Identifier Type: -

Identifier Source: org_study_id