Explore the Use of Cortical Oxygenation Measures in Nutrition Research

NCT07191665 | Completed

• 1 other identifier: 2305NR
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (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. Cognitive performance will be assessed using accuracy and reaction time data collected from cognitive tests, such as memory tests.

  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.

  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.

Study Arms (1)

Healthy adults

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

Other: Acute nutrition intervention

Interventions

Acute nutrition intervention 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.

Healthy adults

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Ecole Polytechnique Fédérale de Lausanne: collaborator

Study Sites (1)

Clinical Innovation Lab

Lausanne, Canton of Vaud, 1000, Switzerland

Location

MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Pamela Pamela, Medical

  Société des Produits Nestlé

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: September 25, 2025
• Study Start: November 20, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 31, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The data will only be available from the preliminary to the last analysis performed (i.e. end of the study).
• Access Criteria: A thesis agreement to cover the data protection has been agreed with the laboratory of the doctoral thesis director. The access to the data will be performed via secure directories of Société des Produits Nestlé.

Locations

CH (1)