Explore the Use of Cortical Oxygenation Measures in Nutrition Research

NCT ID: NCT07191665

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-20
• Study Completion Date: 2025-08-31

Brief 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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Healthy adults

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

Acute nutrition intervention

Intervention Type: OTHER

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.

Interventions

Acute 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.

Intervention Type: OTHER

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ecole Polytechnique Fédérale de Lausanne

OTHER

Sponsor Role: collaborator

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pamela Pamela, Medical

Role: PRINCIPAL_INVESTIGATOR

Société des Produits Nestlé

Locations

Clinical Innovation Lab

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

2305NR

Identifier Type: -

Identifier Source: org_study_id