- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06051175
Study of the Neurophysiological Response to Foodstuffs
Effect of Food Sensorial Perception on Brain Activity, Cardiovascular Activity, Facial Mimicry and Electrodermal Activity
The goal of this clinical trial is to investigate the effect of perception of sensory attributes of different foodstuffs on physiological and neurophysiological response in health adults. The main aims are:
- To evaluate the effect of sensory perception of foodstuffs on brain activity using EEG technique;
- To evaluate the effect of food sensory perception on cardiovascular activity using EGG;
- To evaluate the effect of food sensory perception on facial mimicry via video analysis and eye tracking;
- To evaluate the effect of food sensory perception on electrodermal activity using galvanic skin response.
Participants will perform a sensory attribute perception analysis of 5 different solutions representing basic flavours. During the analysis of sensory attributes, participants will pass the solutions through the various regions of the tongue, and at the end, throw the contents away, not ingesting the solution. Between analyzing the various solutions, participants will rinse their mouth with water.
Simultaneously with the analysis of sensory attributes, each participant will be subjected to an assessment of brain activity and physiological activity through the following non-invasive methods: electroencephalography technique; electrocardiography technique; monitoring cardiac electrical activity; facial mimicry activity via video analysis and eye tracking; and electrodermal activity using galvanic skin response.
Study Overview
Status
Conditions
Detailed Description
Participation in the Study of the neurophysiological response to foodstuffs in university students with the aim of investigating the effect of the perception of the sensory attributes of different foodstuffs on the physiological and neurophysiological response of healthy university students, which consists of the following participation: Completion of a survey with the aim of finding out the participant's family history in terms of pathologies and/or allergies/intolerances, gender, age, medication, smoking habits and lifestyles, anthropometric data.
Participants will carry out an analysis of the perception of sensory attributes of 5 different solutions representing basic flavours. During the analysis of sensory attributes, the participants will have to pass the solutions over the various regions of the tongue, and at the end, throw the contents away, not ingesting the solution. Between analysing the various solutions, participants will rinse their mouths out with water.
Simultaneously with the analysis of sensory attributes, each participant will undergo an assessment of brain activity and physiological activity using the following non-invasive methods: Electroencephalography technique, which consists of monitoring brain electrical activity using a cap with electrodes on the head. The electrocardiography technique, which consists of monitoring cardiac electrical activity by placing 3 electrodes on the forearm. Facial mimicry via video analysis and eye tracking, which consists of monitoring facial mimicry by recording test videos for each participant. The participant will be recorded throughout the experiment. Electrodermal activity using the galvanic response of the skin, where the participant will place their index finger and middle finger on a sensor for analysis. The evaluation of brain activity, which includes all the techniques described above, lasts a maximum of one hour.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Monte De Caparica
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Almada, Monte De Caparica, Portugal, 2829-511
- Instituto Universitário Egas Moniz
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- healthy adults
- agree to take part in the study
- aged between 18 and 25
Exclusion Criteria:
- Participants with cardiovascular, neurological or psychiatric conditions
- Participants with food allergies or intolerances
- Participants with disability that does not allow them to fully utilise their sense of taste (ageusia) and smell (anosmia).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sensory attributes perception - bitter taste
During the experiment individuals will be exposed to caffeine solution, identifying the sensory attributes and basic flavours. Between the tastings of the different foodstuffs, neutralisation phases will occur, where participants will receive a neutral food stimulus. The judgement will be self-reported by the participants after contact with the food. While the study is taking place, physiological and neurophysiological data will be collected from participants: brain activity (EEG); cardiac activity (ECG); electrodermal activity (galvanic skin response); and facial mimicry via video analysis and eye tracking. These data will be analysed using physiological data analysis software. All participant data will be recorded using coding, ensuring anonymity and confidentiality. |
Participants will perform a bitter taste perception analysis. During the analysis of sensory attributes, participants will pass the solutions through the various regions of the tongue, and at the end, throw the contents away, not ingesting the solution. Between analyzing the various solutions, participants will rinse their mouth with water. Simultaneously with the analysis of sensory attributes, each participant will be subjected to an assessment of brain activity and physiological activity through the following non-invasive methods: electroencephalography technique; electrocardiography technique; monitoring cardiac electrical activity; facial mimicry activity via video analysis and eye tracking; and electrodermal activity using galvanic skin response. |
Experimental: Sensory attributes perception - salty taste
Individuals will be exposed to sodium chloride solution, identifying the sensory attributes and basic flavours. Between the tastings of the different foodstuffs, neutralisation phases will occur, where participants will receive a neutral food stimulus. The judgement will be self-reported by the participants after contact with the food. While the study is taking place, physiological and neurophysiological data will be collected from participants: brain activity (EEG); cardiac activity (ECG); electrodermal activity (galvanic skin response); and facial mimicry via video analysis and eye tracking. These data will be analysed using physiological data analysis software. All participant data will be recorded using coding, ensuring anonymity and confidentiality. |
Participants will perform a salty taste perception analysis. During the analysis of sensory attributes, participants will pass the solutions through the various regions of the tongue, and at the end, throw the contents away, not ingesting the solution. Between analyzing the various solutions, participants will rinse their mouth with water. Simultaneously with the analysis of sensory attributes, each participant will be subjected to an assessment of brain activity and physiological activity through the following non-invasive methods: electroencephalography technique; electrocardiography technique; monitoring cardiac electrical activity; facial mimicry activity via video analysis and eye tracking; and electrodermal activity using galvanic skin response. |
Experimental: Sensory attributes perception - sweet taste
Individuals will be exposed to sucrose solution, identifying the sensory attributes and basic flavours. Between the tastings of the different foodstuffs, neutralisation phases will occur, where participants will receive a neutral food stimulus. The judgement will be self-reported by the participants after contact with the food. While the study is taking place, physiological and neurophysiological data will be collected from participants: brain activity (EEG); cardiac activity (ECG); electrodermal activity (galvanic skin response); and facial mimicry via video analysis and eye tracking. These data will be analysed using physiological data analysis software. All participant data will be recorded using coding, ensuring anonymity and confidentiality. |
Participants will perform a sweet taste perception analysis. During the analysis of sensory attributes, participants will pass the solutions through the various regions of the tongue, and at the end, throw the contents away, not ingesting the solution. Between analyzing the various solutions, participants will rinse their mouth with water. Simultaneously with the analysis of sensory attributes, each participant will be subjected to an assessment of brain activity and physiological activity through the following non-invasive methods: electroencephalography technique; electrocardiography technique; monitoring cardiac electrical activity; facial mimicry activity via video analysis and eye tracking; and electrodermal activity using galvanic skin response. |
Experimental: Sensory attributes perception - acid taste
Individuals will be exposed to citric acid solution, identifying the sensory attributes and basic flavours. Between the tastings of the different foodstuffs, neutralisation phases will occur, where participants will receive a neutral food stimulus. The judgement will be self-reported by the participants after contact with the food. While the study is taking place, physiological and neurophysiological data will be collected from participants: brain activity (EEG); cardiac activity (ECG); electrodermal activity (galvanic skin response); and facial mimicry via video analysis and eye tracking. These data will be analysed using physiological data analysis software. All participant data will be recorded using coding, ensuring anonymity and confidentiality. |
Participants will perform a acid taste perception analysis. During the analysis of sensory attributes, participants will pass the solutions through the various regions of the tongue, and at the end, throw the contents away, not ingesting the solution. Between analyzing the various solutions, participants will rinse their mouth with water. Simultaneously with the analysis of sensory attributes, each participant will be subjected to an assessment of brain activity and physiological activity through the following non-invasive methods: electroencephalography technique; electrocardiography technique; monitoring cardiac electrical activity; facial mimicry activity via video analysis and eye tracking; and electrodermal activity using galvanic skin response. |
Experimental: Sensory attributes perception - umami taste
Individuals will be exposed to sodium glutamate monohydrate solution, identifying the sensory attributes and basic flavours. Between the tastings of the different foodstuffs, neutralisation phases will occur, where participants will receive a neutral food stimulus. The judgement will be self-reported by the participants after contact with the food. While the study is taking place, physiological and neurophysiological data will be collected from participants: brain activity (EEG); cardiac activity (ECG); electrodermal activity (galvanic skin response); and facial mimicry via video analysis and eye tracking. These data will be analysed using physiological data analysis software. All participant data will be recorded using coding, ensuring anonymity and confidentiality. |
Participants will perform a umami taste perception analysis. During the analysis of sensory attributes, participants will pass the solutions through the various regions of the tongue, and at the end, throw the contents away, not ingesting the solution. Between analyzing the various solutions, participants will rinse their mouth with water. Simultaneously with the analysis of sensory attributes, each participant will be subjected to an assessment of brain activity and physiological activity through the following non-invasive methods: electroencephalography technique; electrocardiography technique; monitoring cardiac electrical activity; facial mimicry activity via video analysis and eye tracking; and electrodermal activity using galvanic skin response. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The mean value of electroencephalography signal components at different flavours
Time Frame: During the intervention
|
The mean value of electroencephalography (EEG) signal components delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz), low-beta (12-20 Hz), high-beta (20-30 Hz) and gamma (30-45 Hz) (in decibel) will be measure by the EEG raw signals recorded by a 64-channel EEG device for each flavour
|
During the intervention
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Mean score of valence, arousal, dominance in the Self Assessment Manikin System for each flavour
Time Frame: Immediately after the intervention
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The characterization of the flavour is performed using a 9-point scale for quantifying valence (pleasant/unpleasant), arousal (exciting/calming) and dominance (overwhelming/subtle)
|
Immediately after the intervention
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The mean value of heart rate and heart rate variability computed from the electrocardiography raw signal at different flavours
Time Frame: During the intervention
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The mean value of heart rate (in beats per minute), the heart rate variability (in milliseconds) and will be measure bt the electrocardiography (ECG) raw signal recorded by an ECG device for each flavour
|
During the intervention
|
The left and right pupil dilatation at different flavours
Time Frame: During the intervention
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The left and right pupil dilatation will be extracted from the eye tracker device
|
During the intervention
|
The electrodermal activity values at different flavours
Time Frame: During the intervention
|
The electrodermal activity, namely the skin conductance response and skin conductance level (in microSiemens) will be directly measure by Galvanic skin response device
|
During the intervention
|
Facial expressions induced by different flavours
Time Frame: During the intervention
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The facial expressions (in action units) will be visually measured on the videos that were acquired using a camera
|
During the intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1226Neurophy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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