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Active, Not Recruiting

NCT Number: NCT06548165

Physiological Reaction After Food Intake

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Physiological Reactivity to Cues

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universityhospital Ulm

Ulm, 89081, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Electrocardiogram

    Time frame: 2 weeks

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

  2. Body temperature

    Time frame: 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.

  3. Skin conductance

    Time frame: 2 weeks

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

  4. Glucose level

    Time frame: 2 weeks

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

Secondary outcomes

  1. Physical Activity

    Time frame: 2 weeks

    The wearable Vivalink ECG contains an accelerometer to continuously assess activity, intensity and body position.

  2. Food intake

    Time frame: 2 weeks

    Assessed through photo-documentation of consumed food

Other outcomes

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

    Time frame: 2 weeks

    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. Sex differences

    Time frame: 2 weeks

    Differences in the obtained physiological measures between sexes will be analyzed.

  3. Correlation with glycemic and insulin sensitivity

    Time frame: 2 weeks

    Correlation of the obtained physiological measures among with glycemic, lipidemia, and insulin sensitivity will be analyzed.

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Acronym: NutriPulse

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 12, 2024
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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