Acoustic Tribology Validation Study

October 13, 2017 updated by: NIZO Food Research

Validation Study to Evaluate the Use of Acoustic Tribology to Assess Mouthfeel of Dairy Drinks

Dairy-based beverages contain fat and sugars. As both contribute to the energy intake upon consumption, food industry strives to reduce these ingredients while maintaining the taste, texture and aroma properties of the beverages. A successful reduction of fat and sugar from drinks has still proven a great challenge since consumers have less preference for the mouth feel of reformulated beverages than for the regular beverages. Mainly because instrumental measures like rheology and traditional tribology do not entirely predict the experienced mouth feel, there is an interest in alternative correlates for mouth feel aspects related to fat and sugar perception. In a recent study it was demonstrated that vibrations produced during interaction between the tongue, palate and beverages during consumption are very sensitive to the amount of fat and texturizers in the beverage. The present study aims at clarifying that relation for a larger panel of human subjects, by systematically evaluating vibration spectra during consumption of dairy beverages that differ in fat content, sugar content or pH. Secondly, the correlation of vibration spectra (acoustic tribology) with mouth feel-related sensory properties and composition of fat deposits on the tongue will be assessed.

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.

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.
17

Contacts and Locations

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

Study Locations

  • Netherlands
      • Ede, Netherlands, 6718 ZB
        • NIZO food 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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

16 volunteers from the local general population

Description

Inclusion Criteria:

  • Age 18-65 years
  • Healthy set of teeth
  • Ability to work with sensory descriptors for dairy products.
  • Able to produce an acoustic signal that is larger than the background signal
  • Voluntary participation
  • Having given written informed consent
  • Willing to comply with study procedures
  • Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data
  • Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned

Exclusion Criteria:

  • Wearing dentures
  • Inability to comply with instructions for acoustic tribology
  • A self-reported food allergy or sensitivity for ingredients of the test products

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

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
Powers in segments of time-frequency transferred vibration data
Time Frame: between 2s and 20s after consumption of each sip
Spectral powers of acoustic signals (in V^2/s) produced by tongue-palate interactions during consumption of various foods in the bands 60-300Hz and 400-2000Hz.
between 2s and 20s after consumption of each sip
Ratios of powers in segments of time-frequency transferred vibration data
Time Frame: 2-20 seconds after consumption of each sip
Ratios of spectral powers in the 400-2000Hz band over powers in the 60-300Hz band of acoustic signals produced by tongue-palate interactions during consumption of various foods (unit-free).
2-20 seconds after consumption of each sip

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
Reported rating of product thickness
Time Frame: 0-2 sec after consumption of each sip
Evaluation of product thickness on a Visual Analogue Scale (mm distance from the lower anchor)
0-2 sec after consumption of each sip
Relative fat content in the collected tongue coating
Time Frame: 2-20 sec after consumption of each sip
percentage of fat encountered in tongue coating that was collected with a swab immediately after consumption
2-20 sec after consumption of each sip
Reported rating of product Creaminess
Time Frame: 0-2 sec after consumption of each sip
Evaluation of product creaminess on a Visual Analogue Scale (mm distance from the lower anchor)
0-2 sec after consumption of each sip
Reported rating of product Roughness
Time Frame: 0-2 sec after consumption of each sip
Evaluation of product roughness on a Visual Analogue Scale (mm distance from the lower anchor)
0-2 sec after consumption of each sip
Relative sugar content in the collected tongue coating
Time Frame: 2-20 seconds after bite consumption
percentage of sugars encountered in tongue coating that was collected with a swab immediately after consumption
2-20 seconds after bite consumption
Relative protein content in the collected tongue coating
Time Frame: 2-20 seconds after bite consumption
percentage of protein encountered in tongue coating that was collected with a swab immediately after consumption
2-20 seconds after bite consumption

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.
NIZO Food Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Top Institute Food and Nutrition

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: Harold Bult, PhD, NIZO food research

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

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.
November 1, 2014

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.
January 1, 2015

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.
January 1, 2015

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).
September 8, 2014

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.
September 16, 2014

First Posted (Estimate)

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.
September 19, 2014

Study Record Updates

Last Update Posted (Actual)

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.
October 16, 2017

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.
October 13, 2017

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.
October 1, 2017

More Information

Terms related to this study

Keywords

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.
  • NIZO 105356

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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