Physiological Reaction After Food Intake

Not Applicable

Recruiting

• Conditions: Physiological Reactivity to Cues
• Interventions: Device: Wearable

• Registration Number: NCT06548165
• Lead Sponsor: University of Ulm

Brief Summary

The goal of this clinical trial is to clarify the normal response of the body after food intake.

Therefore, participants will wear three wearables for two weeks and document their food intake via an app- and picture-based protocol.

Detailed Description

The aim of this study is to investigate physiologically measurable reactions of the body to food intake. We want to find out which of the parameters collected can provide information about food intake and which techniques for data collection are expedient in this context. Ultimately, the aim is to develop a way of determining food intake from physiological data from physiological data without the user indicating this to the device.

The following data is collected continuously over a period of 2 weeks: Electrocardiogram (ECG), pulse rate from photoplethysmogram, body temperature, movement, skin conductance, and a continuous glucose measurement in the interstitium (CGM). The test subjects will also be asked to document each of their meals and snacks via an app using a photo. As an optional additional examination, female study participants will be offered an intravaginal temperature measurement. This independently performed measurement enables the core body temperature to be recorded.

Study Timeline

• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-09
• Study First Posted: 2024-08-12
• Status Verified: 2024-10
• Study Start: 2024-11-12
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-29
• Primary Completion: 2026-09
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• BMI 18.5 - 25 kg/m2

Exclusion Criteria

• vegan diet
• any kind of special diet, e.g. to lose weight
• use of medication, except for thyroid hormones and contraceptives

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Wearables	Wearable	Participants will wear at least three sensors for the measurement of different physiological outcomes (heat rate variability, skin conductance, pulserate) for two weeks. Women can use a fourth sensor to measure the body core temperature intravaginally. Food intake will be assessed via photos.

Primary Outcome Measures

Name	Time	Method
Electrocardiogram	2 weeks	Changes in heart rate variability in response to food intake. Assessed through Vivalink ECG wearable that measures a continuous 3-channel ECG.
Body temperature	2 weeks	Changes in body temperature in response to food intake. Vivalink ECG and CORE sensor continuously measure the skin temperature. CORE sensor is also able to determine the body core temperature via a heat flux sensor. For women, body core temperature can be measured with the trackle wearable.
Skin conductance	2 weeks	Changes in skin conductance in response to food intake. CardioWatch wearable continuously measures the skin conductance
Glucose level	2 weeks	Changes in glucose levels in the interstitium in response to food intake. FreeStyle libre sensors continuously measure the glucose levels.

Secondary Outcome Measures

Name	Time	Method
Physical Activity	2 weeks	The wearable Vivalink ECG contains an accelerometer to continuously assess activity, intensity and body position.
Food intake	2 weeks	Assessed through photo-documentation of consumed food

Trial Locations

Locations (1)

Universityhospital Ulm; 🇩🇪 Ulm, Germany