Identifying Wearable Biomarkers to Monitor Dietary Intake

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorImperial College London

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • High Calorie Meal Intervention

    Other intervention

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

  • Low Calorie Meal Intervention

    Other intervention

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

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: High Calorie, Then Low CalorieExperimental treatment 2 interventions
Group B: Low Calorie, Then High CalorieExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
2

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

Time frame
Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
3

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

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

Time frame
Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
4

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

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

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

Secondary outcomes

1

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

Differences on heart rate in bmp between high and low calorie meals

Time frame
Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
2

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

Differences on systolic and diastolic blood pressure in mmHg between high and low calorie meals

Time frame
Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
3

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

Differences on systolic and diastolic blood pressure in mmHg between high and low calorie meals

Time frame
Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
4

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

Differences on skin temperature in celsius between high and low calorie meals

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.