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CompletedNCT07191665SagaUpdated Sep 25, 2025

Explore the Use of Cortical Oxygenation Measures in Nutrition Research

An observational study in Healthy, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in Switzerland. Open to participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2025-09-25.

Sponsored by Société des Produits Nestlé (SPN) · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
37
Ages
25 Years to 35 Years
Sex
All
01

Study summary

The current project aims to explore the use of cortical oxygenation measures obtained with functional Near Infrared Spectroscopy (fNIRS) in acute nutrition interventions with outcomes on cognition.

Read the detailed description

The project aims to test a previously developed fNIRS-based protocol for evaluating the acute effects of dietary components on cognitive function in a population of healthy young adults. The testing will involve detecting patterns in fNIRS-based cortical tissue oxygenation level and cognitive performance that are expected due to the bioactive mechanisms of the studied components.

02

Conditions studied

  • Healthy

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Keywords

  • Functional Near Infrared Spectroscopy
  • Cortical tissue oxygenation
  • Cognition
  • Mental fatigue
  • Workload
  • Caffeine
  • L-Arginine
03

In context

Mental Fatigue

154 studies on the registry are indexed under Mental Fatigue; 54 are open to participants now.

This study's enrollment of 37 is below the median of 73 across 30 observational studies indexed under Mental Fatigue.

Browse Mental Fatigue studies →

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 35 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

The study population will comprise of 36 healthy adults from 25 to 35 years old. To analyze gender-related differences, the population will be equally distributed according to gender.

Inclusion criteria

  • Males and Females 25-35 years old
  • BMI between 18.5 kg/m2 and 29.9 kg/m2
  • Conditions for study procedure compliance:

    • Willing and able to sign an informed consent form
    • Fluent in English (self-reported C1 or C2 English level)
    • Have reliable cortical oxygenation signal for subsequent analysis (based on the real-time computation of a parameter reflecting the quality of the signal, which may be influenced by variations in hair thickness)
    • Dominant right-handed
    • Have normal or corrected-to-normal vision
    • Willing and able to comply with the protocol requirements

Exclusion criteria

Exclusion Criteria:

  • Conditions that may affect cortical oxygenation:

    • Have a past or current neural, cerebrovascular, cardiovascular, or respiratory disease (based on anamnesis)
    • Have a past or current kidney disease or condition (based on anamnesis)
    • Measured hypo- or hyper-tension (verified by evaluating Blood Pressure, BP, measure against medical norms at screening)
    • Self-reported, suspected or diagnosed migraine (based on anamnesis)
    • Have a mild or clinical form of insomnia (verified by thresholding rated insomnia severity index, ISI, at or above 8) or being a night shift worker (based on anamnesis)
    • Regular smoker, regularly is being defined as more than 2 cigarettes per week
    • Participating in vigorous physical activity defined as requiring more than 6 metabolic equivalents (e.g., hiking, jogging at 10 km/h or more, carrying of heavy loads, bicycling fast at 23 km/h or more, basketball, soccer, and tennis single), greater than 4 times 45 minutes per week
  • Conditions that may affect cognition or mental fatigue:

    • Have a current psychiatric disorder or have a self-reported, suspected or diagnosed anxiety or depression (based on anamnesis)
    • Taking illicit drugs for e.g., cannabis, heroin, and cocaine
    • Have an average alcohol consumption defined as greater than 2 standard drinks per day over a week for males, and greater than 1 standard drink per day over a week for females. One standard drink contains 10-12 g of ethanol. Examples of standard drinks are one beer can (300 ml), one glass of wine (100 ml) or one glass of schnaps (30 ml).
    • Pregnant (verified by a pregnancy test in urine dipstick format provided by the study's site) or seeking to become pregnant or breast feeding (based on anamnesis)
  • Conditions that may interact with the IP mechanism:

    • Have food allergies and intolerances (based on anamnesis)
    • Have a high usual consumption of caffeine-based beverages and foods (verified by thresholding the daily consumption of caffeine as determined by the Caffeine Consumption Questionnaire, CCQ, at or above 600mg)
    • Body mass below 60kg (associated with a dosing of more than 3mg caffeine per 1kg of body mass)
    • Currently taking Sildenafil (based on anamnesis)
    • Self-reported, suspected or diagnosed with acute inflammatory diseases e.g., herpes simplex virus, allergies, or asthma (based on anamnesis)
  • Have a hierarchal or family relationship with any of the research team members.
  • Currently participating in an interventional study.
05

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
37 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy adults

    Healthy males and females aged between 25 and 35 years old.

    Other: Acute nutrition intervention

Interventions

  • OtherAcute nutrition intervention

    The products (investigational and placebo) consists of three capsules that should be taken with water at two separate visits, with a wash-out period in between. The placebo product will comprise of microcrystalline cellulose (bulk). The investigational products will contain either caffeine and microcrystalline cellulose or caffeine, L-Arginine, and microcrystalline cellulose.

06

What researchers measure

Primary outcomes

  1. Caffeine-induced pattern of correlation between cortical tissue oxygenation and cognitive performance (relative to placebo).

    Detect a pattern of correlation between caffeine-induced changes in cortical tissue oxygenation and cognitive performance. Cognitive performance will be assessed using accuracy and reaction time data collected from cognitive tests, such as memory tests.

    Time frame: Change in correlation from baseline to 45' post-product intake ; This measurement is performed for each product. Each product is given a single time. 5-9 days between each of the products assigned.

  2. Caffeine-induced pattern of correlation between cortical tissue oxygenation and cognitive performance (relative to placebo)

    Detect a pattern of correlation between caffeine-induced changes in cortical tissue oxygenation and cognitive performance. Cortical tissue oxygenation level will be measured by analyzing changes in oxygenated or deoxygenated hemoglobin concentration.

    Time frame: Change in correlation from baseline to 45' post-product intake ; This measurement is performed for each product. Each product is given a single time. 5-9 days between each of the products assigned.

07

Study locations

1 site
  • Clinical Innovation Lab
    Lausanne, Canton of Vaud 1000, Switzerland
08

References and documents

Individual participant data

Plan to share: Yes — Access to the data will only be given to the academic laboratory hosting the the aforementioned doctoral study. This concerns the Medical Image Processing laboratory, Ecole Polytechnique Fédérale de Lausanne.

Supporting information: Study protocol, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07191665
Lead sponsor
Société des Produits Nestlé (SPN)
Collaborators
Ecole Polytechnique Fédérale de Lausanne
Responsible party
Sponsor
First posted
Sep 25, 2025
Start date
Nov 20, 2023
Primary completion
Jun 30, 2024
Completion
Aug 31, 2025
Last update
Sep 25, 2025

Study contacts

Pamela Pamela, Medical
principal investigator · Société des Produits Nestlé

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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