Different Dietary Patterns

Sponsor

University of Vienna (Other)

Overall Status

Recruiting

CT.gov ID

NCT06147440

Collaborator

(none)

Enrollment

Location

Arms

11.4

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diet, Healthy Endotoxemia	Other: Dietary intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Different Dietary Patterns: Investigations in Healthy Participants

Actual Study Start Date :

Oct 20, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Changes in parameters of intestinal barrier function [1 week]
Changes in TLR ligand serum levels

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Vienna	Vienna		Austria

Sponsors and Collaborators

University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Dr. Ina Bergheim, Principal Investigator, University of Vienna

ClinicalTrials.gov Identifier:

NCT06147440

Other Study ID Numbers:

UVienna22

First Posted:

Nov 27, 2023

Last Update Posted:

Nov 27, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endotoxemia

Study Results

No Results Posted as of Nov 27, 2023