NCT06548165

Physiological Reaction After Food Intake

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Physiological Reactivity to Cues

Interventions

Type	Name	Description
DEVICE	Wearable	Participants will wear an electrode on the chest for the measurement of the heart rate variability, a sensor for temperature measurement, and a sensor for continuous blood glucose measurement. Food intake will be recorded via pictures. One mixed meal tolerance test will be performed as a reference for further analyses. Females have the option to use a device for intravaginal temperature measurement.

Timeline

• Start date: 2024-11-12
• Primary completion: 2025-08-14
• Completion: 2026-10-01
• First posted: 2024-08-12
• Last updated: 2025-12-03

Locations

1 site across 1 country: Germany