Different Dietary Patterns

Different Dietary Patterns: Investigations in Healthy Participants

The aim of the present study is to determine the effects of different standardized dietary patterns on general health markers, intestinal function, immune response and affective processes/ cognitive skills in healthy subjects.

Study Overview

• Status: Recruiting
• Conditions: Endotoxemia; Diet, Healthy
• Intervention / Treatment: Other: Dietary intervention

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Recruiting
    • University of Vienna
    • Contact: Ina Bergheim, Prof. Dr.; Phone Number: +431427754981; Email: ina.bergheim@univie.ac.at
    • Contact: Annette Brandt, Dr.; Phone Number: +43427754984; Email: annette.brandt@univie.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• BMI between 18.5 kg/m² und 24.9 kg/m²

Exclusion Criteria:

• Chronic inflammatory diseases
• Metabolic diseases
• Viral or bacterial infections in the last 3 weeks
• Allergic reactions in the last 3 weeks
• Intake of anti-inflammatory drugs
• Malignant diseases
• Pregnancy and lactation
• Smoking
• Alcohol consumption > 10 g/d for women and > 20 g/d for men
• Drug consumption
• Vegetarian or vegan diet
• Food intolerances

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary pattern 1; Participants receive a standardized diet following the recommendation of DACH nutrition societies.	Other: Dietary intervention; Participants receive diets following different dietary patterns for 1 week.
Experimental: Dietary pattern 2; Participants receive a standardized diet following the recommendation of DACH nutrition societies.	Other: Dietary intervention; Participants receive diets following different dietary patterns for 1 week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in parameters of intestinal barrier function	Changes in TLR ligand serum levels	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in parameters of immune response	Changes in concentration of Interleukin-6 in cell culture supernatant of stimulated immune cells	1 week
Changes in blood lipid levels	Changes in triglyceride, cholesterol levels [mg/dl]	1 week
Changes in cognitive skills	Assessment of cognitive processes using computer-based psychological tasks (Stroop effect; calculation of differences in response times to incongruent vs. congruent word-color associations)	1 week

Collaborators and Investigators

• Sponsor: University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 23, 2023
• First Posted (Actual): November 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Bacteremia; Toxemia; Endotoxemia
• Other Study ID Numbers: UVienna22

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
• product manufactured in and exported from the U.S.: No