Physiological Reaction After Food Intake (NutriPulse)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Physiological Reactivity to Cues
• Intervention / Treatment: Device: Wearable

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Ulm, Germany, 89081
    • Universityhospital Ulm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of physiological measures (electrocardiogram, pulserate, body temperature, skin conductance, glucose level)	Correlation of the obtained physiological measures (electrocardiogram, pulserate, body temperature, skin conductance, glucose level) among each other and with food quantity and quality will be assessed	2 weeks
Sex differences	Differences in the obtained physiological measures between sexes will be analyzed.	2 weeks
Correlation with glycemic and insulin sensitivity	Correlation of the obtained physiological measures among with glycemic, lipidemia, and insulin sensitivity will be analyzed.	2 weeks

Collaborators and Investigators

• Sponsor: University of Ulm
• Investigators: Principal Investigator: Martin Heni, MD, University of Ulm

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Actual): August 14, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: wearables; food intake; physiologic reaction
• Additional Relevant MeSH Terms: Equipment and Supplies; Electrical Equipment and Supplies; Wearable Electronic Devices
• Other Study ID Numbers: 168/24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No