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Identifying Wearable Biomarkers to Monitor Dietary Intake

Sponsor: Imperial College London

NCT ID: NCT06398340

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
High Calorie Meal Intervention (other), Low Calorie Meal Intervention (other)
How long the study runs
Study runs about 11 months (dates as stated)
About the drug or intervention
High Calorie Meal Intervention — other: Subjects will receive a unhealthy meal high in calorie, sugar and fat · Low Calorie Meal Intervention — other: Subjects will receive a healthy meal with balanced macronutrient, high in vegetables and dietary fibre
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 65 Years
Who
All
Number of participants
10
Started
2024-08-19
Last checked
2025-02

Plain English Summary

What is this study?

  • • Testing a new treatment for energy intake
  • • NA - 10 participants
  • • Background: Measuring what people eat is a challenge in nutrition research

Who can take part?

  • • Ages 18 Years to 65 Years
  • • Diagnosed with energy intake

Where?

  • • London - NIHR Imperial College London Clinical Research Facility

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Energy IntakeMetabolismDigestionWearablesDietary Intake AssessmentHealthy VolunteersBlood Glucose

How this trial compares with your answers

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 65 Years
  • Who can join: All genders

What the study is looking for

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

Who cannot take part

  • ✗Outside of specified age and BMI range
  • ✗Taking part in another research study or donating any blood in the last 3 months
See the full 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

Where Is This Study? (1 UK site)

NIHR Imperial College London Clinical Research Facility

London W12 0NN, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Mingzhu Cai, PhD

Sponsor contact

CONTACT

+44(0)7395757128 m.cai18@imperial.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-02