Identifying Wearable Biomarkers to Monitor Dietary Intake

NCT06398340 | Recruiting

• 1 other identifier: 23HH8489
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Dietary intake monitoring; wearable sensors; digital health; blood glucose

Outcome Measures

Primary Outcomes (5)

• Changes of heart rate associated with dietary events (pre- vs post- meal).

  Heart rate in bpm before, during and after the dietary event

  Starting 5 minutes before the meal and lasting for 60 minutes postprandially.

• Changes of blood pressure associated with dietary events (pre- vs post- meal).

  Systolic and diastolic blood pressure in mmHg before, during and after the dietary event

  Starting 5 minutes before the meal and lasting for 60 minutes postprandially.

• Changes of oxygen saturation associated with dietary events (pre- vs post- meal).

  Oxygen saturation in % before, during and after the dietary event

  Starting 5 minutes before the meal and lasting for 60 minutes postprandially.

• Changes of skin temperature associated with dietary events (pre- vs post- meal).

  Skin temperature in celsius before, during and after the dietary event

  Starting 5 minutes before the meal and lasting for 60 minutes postprandially.

• Changes of hand movements associated with dietary events (pre- vs post- meal).

  Hand movements recorded in sensors before, during and after the dietary event

  Starting 5 minutes before the meal and lasting for 60 minutes postprandially.

Secondary Outcomes (6)

• Changes of heart rate associated with energy intake (high vs. low calorie meals)

  Starting 5 minutes before the meal and lasting for 60 minutes postprandially.

• Changes of blood pressure associated with energy intake (high vs. low calorie meals)

  Starting 5 minutes before the meal and lasting for 60 minutes postprandially.

• Changes of heart oxygen saturation associated with energy intake (high vs. low calorie meals)

  Starting 5 minutes before the meal and lasting for 60 minutes postprandially.

• Changes of skin temperature associated with energy intake (high vs. low calorie meals)

  Starting 5 minutes before the meal and lasting for 60 minutes postprandially.

• Changes of hand movements associated with energy intake (high vs. low calorie meals)

  Starting 5 minutes before the meal and lasting for 60 minutes postprandially.

Study Arms (2)

High Calorie, Then Low Calorie

EXPERIMENTAL

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.

Other: High Calorie Meal Intervention; Other: Low Calorie Meal Intervention

Low Calorie, Then High Calorie

EXPERIMENTAL

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

Other: High Calorie Meal Intervention; Other: Low Calorie Meal Intervention

Interventions

High Calorie Meal Intervention OTHER

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

High Calorie, Then Low Calorie; Low Calorie, Then High Calorie

Low Calorie Meal Intervention OTHER

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

High Calorie, Then Low Calorie; Low Calorie, Then High Calorie

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

NIHR Imperial College London Clinical Research Facility

London, W12 0NN, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 41053911 DERIVED

Study Officials

• Mingzhu Cai, PhD

  Nutrition Research Section, Imperial College London

  STUDY CHAIR

• Mayue Shi, PhD

  Department of Electrical and Electronic Engineering, Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingzhu Cai, PhD

CONTACT

+44(0)7395757128; m.cai18@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 3, 2024
• Study Start: August 19, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)