Nutritional Modulation of Cognition and Brain Activity

April 22, 2024 updated by: Stefan Schulreich, University of Vienna

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standardized meal with macronutrient composition 1
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)
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)
Experimental: Standardized meal with macronutrient composition 2
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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in cognition/behavior I
Time Frame: 3-4.5 hours (post-meal)
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)
Changes in cognition/behavior II
Time Frame: 3-4.5 hours (post-meal)
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)
Changes in brain activity
Time Frame: 3-4.5 hours (post-meal)
Changes in brain activity measured via functional magnetic resonance imaging;
3-4.5 hours (post-meal)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in metabolic parameters I
Time Frame: from baseline (prior meal) to approx. 4.5 hours after meal at several time points
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
Changes in metabolic parameters II
Time Frame: from baseline (prior meal) to approx. 4.5 hours after meal at several time points
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
Changes in metabolic parameters III
Time Frame: from baseline (prior meal) to approx. 4.5 hours after meal at several time points
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
Changes in metabolic parameters IV
Time Frame: from baseline (prior meal) to approx. 4.5 hours after meal at several time points
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
Changes in subjective affective state
Time Frame: from baseline (prior meal) to approx. 4.5 hours after meal at several time points
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
Changes in experienced hunger
Time Frame: rom baseline (prior meal) to approx. 4.5 hours after meal at several time points
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vienna

Collaborators

Medical University of Vienna

Investigators

  • Principal Investigator: Stefan Schulreich, Prof. Dr., University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

April 7, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • UVienna_NDNL_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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