Nutritional Modulation of Cognition and Brain Activity

NCT06386237 | Recruiting

• 1 other identifier: UVienna_NDNL_1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nutrition, Healthy; Cognitive Change; Brain Activity

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• Changes in brain activity

  Changes in brain activity measured via functional magnetic resonance imaging;

  3-4.5 hours (post-meal)

Secondary Outcomes (6)

• Changes in metabolic parameters I

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

• Changes in metabolic parameters II

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

• Changes in metabolic parameters III

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

• Changes in metabolic parameters IV

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

• Changes in subjective affective state

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

Study Arms (2)

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)

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)

Other: Dietary intervention: Standardized breakfast with varying amounts of macronutrients (in particular carbohydrate/protein ratios)

Interventions

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)

Standardized meal with macronutrient composition 1; Standardized meal with macronutrient composition 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vienna: lead
• Medical University of Vienna: collaborator

Study Sites (1)

University of Vienna

Vienna, 1090, Austria

RECRUITING

Study Officials

• Stefan Schulreich, Prof. Dr.

  University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Schulreich, Prof. Dr.

CONTACT

+4314277; stefan.schulreich@univie.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.-Prof. Dr.

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 26, 2024
• Study Start: April 8, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)