Physiological Reaction After Food Intake

NCT ID: NCT06548165

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2026-10-31

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.

Conditions

Physiological Reactivity to Cues

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Wearables

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.

Group Type: EXPERIMENTAL

Wearable

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

Martin Heni

Prof. Dr. med. Martin Heni

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Heni, MD

Role: PRINCIPAL_INVESTIGATOR

University of Ulm

Locations

Universityhospital Ulm

Ulm, , Germany

Countries

Germany

Other Identifiers

168/24

Identifier Type: -

Identifier Source: org_study_id