Physiological Reaction After Food Intake (NutriPulse)

University of Ulm

Status: Enrolling

Conditions: Physiological Reactivity to Cues

Treatments: Device: Wearable

Study type: Interventional

Funder types: Other

Identifiers

NCT06548165

168/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Wearables

Experimental group

Description:

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.

Treatment:

Device: Wearable