NCT06147440

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 31, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 27, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

October 31, 2023

Last Update Submit

April 10, 2025

Conditions

Diet, HealthyEndotoxemia

Outcome Measures

Primary Outcomes (1)

  • Changes in parameters of intestinal barrier function

    Changes in TLR ligand serum levels

    1 week

Secondary Outcomes (3)

  • Changes in parameters of immune response

    1 week

  • Changes in blood lipid levels

    1 week

  • Changes in cognitive skills

    1 week

Study Arms (2)

Dietary pattern 1

EXPERIMENTAL

Participants receive a standardized diet following the recommendation of DACH nutrition societies.

Other: Dietary intervention

Dietary pattern 2

EXPERIMENTAL

Participants receive a standardized diet following the recommendation of DACH nutrition societies.

Other: Dietary intervention

Interventions

Dietary interventionOTHER

Participants receive diets following different dietary patterns for 1 week.

Dietary pattern 1Dietary pattern 2

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vienna

Vienna, Austria

RECRUITING

MeSH Terms

Conditions

Endotoxemia

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

BacteremiaSepsisInfectionsToxemiaSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

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
Principal Investigator

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 27, 2023

Study Start

October 20, 2023

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

April 15, 2025

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)