Physiological Reaction After Food Intake

NCT06548165 | Active Not Recruiting

• 1 other identifier: 168/24
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Physiological Reactivity to Cues

Keywords

wearables; food intake; physiologic reaction

Outcome Measures

Primary Outcomes (4)

• Electrocardiogram

  Changes in heart rate variability in response to food intake. Assessed through Vivalink ECG wearable that measures a continuous 3-channel ECG.

  2 weeks

• Body temperature

  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.

  2 weeks

• Skin conductance

  Changes in skin conductance in response to food intake. CardioWatch wearable continuously measures the skin conductance

  2 weeks

• Glucose level

  Changes in glucose levels in the interstitium in response to food intake. FreeStyle libre sensors continuously measure the glucose levels.

  2 weeks

Secondary Outcomes (2)

• Physical Activity

  2 weeks

• Food intake

  2 weeks

Other Outcomes (3)

• Correlation of physiological measures (electrocardiogram, pulserate, body temperature, skin conductance, glucose level)

  2 weeks

• Sex differences

  2 weeks

• Correlation with glycemic and insulin sensitivity

  2 weeks

Study Arms (1)

Wearables

EXPERIMENTAL

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.

Device: Wearable

Interventions

Wearable 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.

Wearables

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 18.5 - 25 kg/m2

You may not qualify if:

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

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

Universityhospital Ulm

Ulm, 89081, Germany

Location

MeSH Terms

Interventions

Wearable Electronic Devices

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Martin Heni, MD

  University of Ulm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Martin Heni

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 12, 2024
• Study Start: November 12, 2024
• Primary Completion: August 14, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

DE (1)