Nutrition, HealthyNCT06386237
Nutritional Modulation of Cognition and Brain Activity
A study testing Dietary intervention: Standardized breakfast with varying amounts of macronutrients (in particular carbohydrate/protein ratios) in people with Nutrition, Healthy and Cognitive Change, run by University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy, Cognitive Change, Brain Activity
- What is being tested?
- Dietary intervention: Standardized breakfast with varying amounts of macronutrients (in particular carbohydrate/protein ratios)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 8 Apr 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- vegan or vegetarian diet
- food intolerances
- females: hormonal contraception, pregnancy, lactation
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
University of Vienna
Vienna, 1090
Stefan Schulreich, Prof. Dr., +4314277 ext. 54960, stefan.schulreich@univie.ac.at
About this study
Official title: 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.
- Conditions
- Nutrition, Healthy, Cognitive Change, Brain Activity
- Being tested
- Dietary intervention: Standardized breakfast with varying amounts of macronutrients (in particular carbohydrate/protein ratios)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention: Standardized breakfast with varying amounts of macronutrients (in particular carbohydrate/protein ratios)Other
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)
| Study group | Role | What they receive |
|---|---|---|
| Standardized meal with macronutrient composition 1 | Experimental | 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) Receives: Other: Dietary intervention: Standardized breakfast with varying amounts of macronutrients (in particular carbohydrate/protein ratios) |
| Standardized meal with macronutrient composition 2 | Experimental | 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) Receives: Other: Dietary intervention: Standardized breakfast with varying amounts of macronutrients (in particular carbohydrate/protein ratios) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3-4.5 hours (post-meal)
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.
Measured: 3-4.5 hours (post-meal)
Changes in brain activity
Changes in brain activity measured via functional magnetic resonance imaging;
Measured: 3-4.5 hours (post-meal)
Secondary outcomes (6)
Changes in metabolic parameters I
Changes in the concentrations of amino acids (assessed via blood samples and chemical analysis)
Measured: from baseline (prior meal) to approx. 4.5 hours after meal at several time points
Changes in metabolic parameters II
Changes in the concentrations of glucose (assessed via blood samples and chemical analysis)
Measured: from baseline (prior meal) to approx. 4.5 hours after meal at several time points
Changes in metabolic parameters III
Changes in the concentrations of insulin (assessed via blood samples and chemical analysis)
Measured: from baseline (prior meal) to approx. 4.5 hours after meal at several time points
Changes in metabolic parameters IV
Changes in the concentration of cortisol (assessed via saliva samples and chemical analysis)
Measured: from baseline (prior meal) to approx. 4.5 hours after meal at several time points
Changes in subjective affective state
Changes in reported affect ("Multidimensionaler Befindlichkeitsfragebogen" - multidimensional mood scale; Steyer et al., 1997)
Measured: from baseline (prior meal) to approx. 4.5 hours after meal at several time points
Changes in experienced hunger
Changes in subjective reported hunger (assessed via single-item Likert-Scale)
Measured: rom baseline (prior meal) to approx. 4.5 hours after meal at several time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start8 Apr 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna
- Responsible party
- Principal investigator, Stefan Schulreich, University of Vienna
- Investigators
- Stefan Schulreich, Prof. Dr., Principal investigator, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386237
- Sponsor's protocol ID
- UVienna_NDNL_1
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Modulation of Learning and Decision Making and Their Underlying Neural Processes
- ClinicalTrials.gov ID
- NCT06386237
- Acronym / sponsor ID
- UVienna_NDNL_1
- Conditions
- Nutrition, Healthy, Cognitive Change, Brain Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Collaborators
- Medical University of Vienna
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized meal with macronutrient composition 1 | Experimental | 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) |
| Standardized meal with macronutrient composition 2 | Experimental | 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) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | Standardized meal with macronutrient composition 1, Standardized meal with macronutrient composition 2 |
Primary outcome
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)
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.
Changes in brain activity
Time frame: 3-4.5 hours (post-meal)
Changes in brain activity measured via functional magnetic resonance imaging;
6 secondary outcomes
Changes in metabolic parameters I
Time frame: 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 metabolic parameters III
Time frame: 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 subjective affective state
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Schulreich, Prof. Dr. principal investigator
University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention: Standardized breakfast with varying amounts of macronutrients (in particular carbohydrate/protein ratios) in people with Nutrition, Healthy and Cognitive Change, run by University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Schulreich, Prof. Dr. (+4314277 ext. 54960, stefan.schulreich@univie.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cognition/behavior I (time frame: 3-4.5 hours (post-meal)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.