Nutritional Modulation of Cognition and Brain Activity

Cognitive Change Clinical Trial

Official title:

Nutritional Modulation of Learning and Decision Making and Their Underlying Neural Processes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06386237
• Other study ID #: UVienna_NDNL_1
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: University of Vienna
• Contact: Stefan Schulreich, Prof. Dr.
• Phone: +4314277
• Email: stefan.schulreich[@]univie.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to investigate the effects of different meal interventions on cognition (i.e., learning and decision making) and brain activity in healthy participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 18 to 40 years old

• fluent in German

• right-handed

• able to safely undergo MRI scanning

• BMI (Body-Mass-Index) between 18.5 and 29.9 kg/m2

Exclusion Criteria:

• current medication that might interfere with the processes studied

• any metabolic, gastrointestinal, cardiological, neurological, psychiatric or any recurring or chronic diagnoses

• drug use

• alcohol consumption > 10 g/d for women and > 20 g/d for men

• smoking

• shifted circadian rhythm (e.g. jetlag, shift work)

• vegan or vegetarian diet

• food intolerances

• females: hormonal contraception, pregnancy, lactation

Related Conditions & MeSH terms

• Brain Activity
• Cognitive Change

Intervention

Other:
• Dietary intervention: Standardized breakfast with varying amounts of macronutrients (in particular carbohydrate/protein ratios)
Participants receive a standardized meal with one type of macronutrient composition in one experimental session and the other type in a different experimental session a few days apart (within-subjects crossover design; i.e. order counterbalanced)

Locations

Country	Name	City	State
Austria	University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
University of Vienna	Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cognition/behavior I	Changes in learning behavior assessed via computer-based learning task ("predictive inference task") which tracks choices and response times (allows for calculation of learning-related scores: change in prediction choice following feedback)	3-4.5 hours (post-meal)
Primary	Changes in cognition/behavior II	Changes in decision-making behavior assessed via computer-based decision task ("gamble task") which tracks choices (calculation of gamble acceptance frequencies) and response times.	3-4.5 hours (post-meal)
Primary	Changes in brain activity	Changes in brain activity measured via functional magnetic resonance imaging;	3-4.5 hours (post-meal)
Secondary	Changes in metabolic parameters I	Changes in the concentrations of amino acids (assessed via blood samples and chemical analysis)	from baseline (prior meal) to approx. 4.5 hours after meal at several time points
Secondary	Changes in metabolic parameters II	Changes in the concentrations of glucose (assessed via blood samples and chemical analysis)	from baseline (prior meal) to approx. 4.5 hours after meal at several time points
Secondary	Changes in metabolic parameters III	Changes in the concentrations of insulin (assessed via blood samples and chemical analysis)	from baseline (prior meal) to approx. 4.5 hours after meal at several time points
Secondary	Changes in metabolic parameters IV	Changes in the concentration of cortisol (assessed via saliva samples and chemical analysis)	from baseline (prior meal) to approx. 4.5 hours after meal at several time points
Secondary	Changes in subjective affective state	Changes in reported affect ("Multidimensionaler Befindlichkeitsfragebogen" - multidimensional mood scale; Steyer et al., 1997)	from baseline (prior meal) to approx. 4.5 hours after meal at several time points
Secondary	Changes in experienced hunger	Changes in subjective reported hunger (assessed via single-item Likert-Scale)	rom baseline (prior meal) to approx. 4.5 hours after meal at several time points