Interaction of Inflammation, Taste Perception and Preferences As a Function of Physical Activity and Body Composition

November 20, 2024 updated by: Barbara Lieder, University of Vienna

Interaktion Von Ausgewählten Inflammationsparametern, Geschmackswahrnehmung Und Geschmackspräferenzen in Abhängigkeit Von Physischer Aktivität Und Körperzusammensetzung

The aim of this study is to investigate whether differences in taste perception and preference behavior can be attributed to inflammatory processes induced by physical activity. The focus will be on sweet taste and the perception of fat. A non-invasive, observational study design will be used.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study adresses the question of whether there is a connection between low-grade inflammation caused by physical activity and a change in taste perception and preference for the sweet taste. The taste perception, preference behavior and inflammation in athletic and healthy non-athletic subjects using an observational study design is investigated.

The hypothesis is that athletic test subjects, compared to healthy, physically inactive subjects, show increased inflammation values, in the range of a low-grade inflammation, and that this results in a lower sensitivity and increased preference for sweet taste.

The primary parameters to be investigated are a possible correlation between the level of physical activity physical activity or body composition and the recognition threshold for the sweet taste as well as the preference. In addition, a correlation between the concentration of TNF-α and IL-6 in saliva sweet recognition threshold and sweet preference will be investigated.

Secondary parameters to be analyzed are the preference for fatty substances, the perception threshold for the perception threshold for the fatty taste, taste receptors in saliva for the sweet and fatty taste, the concentration of 8-epi-PGF2α in the urine as a marker for oxidative stress, and the number of fungiform papillae on the tongue are determined.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Christian Doppler Laboratory for Taste Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

A total of 66 healthy adult participants, devided into two groups:

Group of athletic test subjects: BMI 18.5 - 29.99 kg/m², intensive training sessions at least 3 days a week and at least 6 h per week Group of healthy, non-athletic test subjects: BMI 18.5 - 24.99 kg/m², sporting activity ≤ 150 min per week

Description

Inclusion Criteria:

  • healthy
  • non-smoking
  • normal taste and smell perception

Exclusion Criteria:

  • pregnancy or breast-feeding
  • regular smokers
  • regular intake of medication
  • metabolic diseases that require drug therapy
  • ageusia or anosmia
  • alcohol or drug addiction
  • intake of antibiotics within the past 2 months
  • vegan diet
  • viral or bacterial infection wihtin the past three weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control
Healthy test subjects, BMI 18.5 - 24.99 kg/m², sporting activity per week ≤ 150 minutes
Athlectic
BMI 18.5 - 29.99 kg/m², intensive physical activity per week > 6 h (spread over min. 3 days)
Behavioral: Physical activity
The control and the athletic group differ in the degree of physical acitvity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Taste sensitivity
Time Frame: day 1
detection threshold for sweet and fatty taste analysed using a 3-AFC test
day 1
Taste preference
Time Frame: day 1
preference for sweet and fatty taste analyzed by means of a Food Frequency Questionnaire and food choices from a standardized breakfast
day 1
Body composition
Time Frame: day 1
body fat percentage
day 1
Low-grade inflammation
Time Frame: day 1
Concentration of interleukin 6 and tumor necrosis factor alpha in unstimulated saliva
day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oxidative Stress
Time Frame: day 1
8-epi-PGF2α analysis in urine
day 1
fungiform papillae density
Time Frame: day 1
The number of fungiform papillae in a definded area of 1 cm² at the tip of the tongue is counted after staining of the tomgue with methylene blute
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Vienna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Barbara Lieder, PhD, University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 706014-4

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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