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RecruitingNCT06386237Updated Apr 26, 2024

Nutritional Modulation of Cognition and Brain Activity

An interventional study of Dietary intervention: Standardized breakfast with varying amounts of macronutrients (in particular carbohydrate/protein ratios) in Nutrition, Healthy, Cognitive Change and Brain Activity, sponsored by University of Vienna. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-26.

Sponsored by University of Vienna · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nutrition, Healthy
  • Cognitive Change
  • Brain Activity
03

In context

Lead sponsor

University of Vienna is the lead sponsor of 47 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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)

  • 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)

Interventions

  • OtherDietary 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)

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 3-4.5 hours (post-meal)

  2. 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.

    Time frame: 3-4.5 hours (post-meal)

  3. Changes in brain activity

    Changes in brain activity measured via functional magnetic resonance imaging;

    Time frame: 3-4.5 hours (post-meal)

Secondary outcomes

  1. Changes in metabolic parameters I

    Changes in the concentrations of amino acids (assessed via blood samples and chemical analysis)

    Time frame: from baseline (prior meal) to approx. 4.5 hours after meal at several time points

  2. Changes in metabolic parameters II

    Changes in the concentrations of glucose (assessed via blood samples and chemical analysis)

    Time frame: from baseline (prior meal) to approx. 4.5 hours after meal at several time points

  3. Changes in metabolic parameters III

    Changes in the concentrations of insulin (assessed via blood samples and chemical analysis)

    Time frame: from baseline (prior meal) to approx. 4.5 hours after meal at several time points

  4. Changes in metabolic parameters IV

    Changes in the concentration of cortisol (assessed via saliva samples and chemical analysis)

    Time frame: from baseline (prior meal) to approx. 4.5 hours after meal at several time points

  5. Changes in subjective affective state

    Changes in reported affect ("Multidimensionaler Befindlichkeitsfragebogen" - multidimensional mood scale; Steyer et al., 1997)

    Time frame: from baseline (prior meal) to approx. 4.5 hours after meal at several time points

  6. Changes in experienced hunger

    Changes in subjective reported hunger (assessed via single-item Likert-Scale)

    Time frame: rom baseline (prior meal) to approx. 4.5 hours after meal at several time points

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06386237
Lead sponsor
University of Vienna
Collaborators
Medical University of Vienna
Responsible party
Stefan Schulreich (Ass.-Prof. Dr., University of Vienna) — Principal investigator
First posted
Apr 26, 2024
Start date
Apr 8, 2024
Primary completion
Feb 28, 2025 (estimated)
Completion
Feb 28, 2025 (estimated)
Last update
Apr 26, 2024

Study contacts

Stefan Schulreich, Prof. Dr.
Contact
stefan.schulreich@univie.ac.at
+4314277 ext. 54960
Stefan Schulreich, Prof. Dr.
principal investigator · University of Vienna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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