HealthySagaNCT07191665
Explore the Use of Cortical Oxygenation Measures in Nutrition Research
An observational study of Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial 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 more about this study
- Who is it for?
- Ages 25 to 35 years
- Conditions the study is for
- Healthy
- What is being tested?
- Acute nutrition intervention
- Type of treatment
- Pill or oral medicine
- How many people
- 37 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Nov 2023to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- All sexes
- Adult
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.
Who may be able to join
- 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)
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- Dominant right-handed
- Have normal or corrected-to-normal vision
- Willing and able to comply with the protocol requirements
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring Cortical Oxygenation Modulations in Response to Dietary Components During Cognitive Activity in Healthy Adults: a fNIRS Study
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.
- Conditions
- Healthy
- Being tested
- Acute nutrition intervention
- Keywords
- Functional Near Infrared Spectroscopy, Cortical tissue oxygenation, Cognition, Mental fatigue, Workload, Caffeine, L-Arginine
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute nutrition interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Healthy males and females aged between 25 and 35 years old. Receives: Other: Acute nutrition intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start20 Nov 2023
- Primary completion30 Jun 2024
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ecole Polytechnique Fédérale de Lausanne
- Responsible party
- Sponsor
- Investigators
- Pamela Pamela, Medical, Principal investigator, Société des Produits Nestlé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191665
- Sponsor's protocol ID
- 2305NR
- Acronym
- Saga
- Status last verified
- Sep 2025
- First submitted
- 7 Dec 2023
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Cortical Oxygenation Modulations in Response to Dietary Components During Cognitive Activity in Healthy Adults: a fNIRS Study
- ClinicalTrials.gov ID
- NCT07191665
- Acronym / sponsor ID
- Saga / 2305NR
- Conditions
- Healthy
- Keywords
- Functional Near Infrared Spectroscopy, Cortical tissue oxygenation, Cognition, Mental fatigue, Workload, Caffeine, L-Arginine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Ecole Polytechnique Fédérale de Lausanne
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | Other: Acute nutrition interventionHealthy males and females aged between 25 and 35 years old. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (9 listed)
- Males and Females 25-35 years old
- BMI between 18.5 kg/m2 and 29.9 kg/m2
- Conditions for study procedure compliance:
Key exclusion criteria (21 listed)
- Conditions that may affect cortical oxygenation:
- Conditions that may affect cognition or mental fatigue:
- Conditions that may interact with the IP mechanism:
- Have a hierarchal or family relationship with any of the research team members.
- Currently participating in an interventional study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute nutrition interventionThe 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. | Other | Healthy adults |
Primary outcome
Caffeine-induced pattern of correlation between cortical tissue oxygenation and cognitive performance (relative to placebo).
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.
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.
Caffeine-induced pattern of correlation between cortical tissue oxygenation and cognitive performance (relative to placebo)
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Pamela, Medical principal investigator
Société des Produits Nestlé
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caffeine-induced pattern of correlation between cortical tissue oxygenation and cognitive performance (relative to placebo). (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.