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| Name | Class |
|---|---|
| Ecole Polytechnique Fédérale de Lausanne | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy adults | Healthy males and females aged between 25 and 35 years old. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
Exclusion Criteria:
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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Pamela, Medical | Société des Produits Nestlé | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Innovation Lab | Lausanne | Canton of Vaud | 1000 | Switzerland |
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.
The data will only be available from the preliminary to the last analysis performed (i.e. end of the study).
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.
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| ID | Term |
|---|---|
| D005222 | Mental Fatigue |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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| D001519 | Behavior |