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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05185765
Other study ID # BOP.study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 25, 2021
Est. completion date December 3, 2021

Study information

Verified date January 2022
Source Wageningen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rationale: The world-wide rising obesity rates are a major health problem. Therefore, people should moderate food intake. A lower eating rate will decrease the energy intake. The eating rate of foods can be modified by changing the texture without affecting their acceptability. Harder, chunkier, more viscous, and more voluminous foods will decrease the eating rate and thus energy intake. Bread is a staple food and contributes to a major part of the Dutch diet. By changing the proofing time and by applying vacuum cooling during the baking process, the texture of bread can be modified. The effect of this texture modification on eating rate is not investigated until now. To get an understanding of the relations between food texture and eating rate, modelling based on instrumental measurements is a promising technique as it can give valuable insights without sensorial and laboratorial labour and costs. However, it is not known if such a model can predict the eating rate as well as a model based on sensory measurements. Therefore, this study will investigate whether modelling of sensory or instrumental data predicts the eating rate of bread most accurate and can be applied for the product development of bread with modified eating rate. Objective: The aim of the BOP-study is to compare mathematical models based on sensory or instrumental texture that predict the eating rate of bread and to validate if the models can be applied for the product development of bread with a modified eating rate by changing the proofing time and applying vacuum cooling. Study design: The study consists out of a sensory study, instrumental measurements, and mathematical modelling. The sensory study is a randomised crossover trial. All participants consume all bread samples in a randomized order divided over four sessions. Every session will be video recorded. Study population: Healthy Dutch adults (n=34) between 18-55 years old, and a BMI between 18.5-30 kg/m2 will be included. Intervention: In the sensory study, participants will attend four test sessions during lunch in which sixteen bread samples will be investigated. Ten breads are commercially available and six breads are produced for product development purposes and differ in proofing time and vacuum cooling. In each session, a fixed portion of bread will be consumed by the participants during which the eating rate and sensory properties will be measured. Additionally, participants will chew and expectorate a bite-size piece of bread in replicate to determine the saliva addition to the bolus at time of swallowing. Main study parameters/endpoints: The main study outcome is the eating rate (g/min).


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date December 3, 2021
Est. primary completion date December 3, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Good general health and appetite (self-report) - Between 18-55 years old at the day of inclusion - Dutch - BMI 18.5-30 kg/m2 (self-report) - Regular consumer of bread Exclusion Criteria: - Smoking - Following a vegan diet - Allergies or intolerance to any ingredient of the test meals - Suffering from diabetes - Having taste or smell disorders (self-report) - Difficulties with swallowing, chewing and/or eating in general - Use of medication that may influence study outcomes (self-report) - Pregnant or lactating women - Braces (not including a dental wire) or oral piercing - Consuming on average more than 21 glasses of alcohol per week - Not willing to stop using drugs during the study period (from inclusion till last test session) - Men having facial hair such as a beard as facial movements cannot be analysed - Signed up for participating in another research study - Employee of Human Nutrition department of Wageningen University - Employee, thesis student or intern at the chair group of Sensory Science and Eating Behaviour or Food Quality and Design (WUR) - Don't like bread products

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Bread
Samples will be provided one by one labeled with an unique code. The mastication and expectorated sample will be given in replicate.

Locations

Country Name City State
Netherlands Wageningen University Wageningen Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Eating rate (g/min) Amount of the sample divided by the consumption time of the sample, measured with video recording Up to 30 minutes
Secondary Overall liking Measured using a 100-mm visual analogue scale (VAS) ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line Assessment will be done once every week for four weeks
Secondary Crumb hardness Measured using a 100-mm visual analogue scale (VAS) ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line Assessment will be done once every week for four weeks
Secondary Crumb dryness Measured using a 100-mm visual analogue scale (VAS) ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line Assessment will be done once every week for four weeks
Secondary Crumb chewiness Measured using a 100-mm visual analogue scale (VAS) ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line Assessment will be done once every week for four weeks
Secondary Crumb adhesiveness Measured using a 100-mm visual analogue scale (VAS) ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line Assessment will be done once every week for four weeks
Secondary Crumb denseness Measured using a 100-mm visual analogue scale (VAS) ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line Assessment will be done once every week for four weeks
Secondary Crust hardness Measured using a 100-mm visual analogue scale (VAS) ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line Assessment will be done once every week for four weeks
Secondary Crust crispiness Measured using a 100-mm visual analogue scale (VAS) ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line Assessment will be done once every week for four weeks
Secondary Crust crumbliness Measured using a 100-mm visual analogue scale (VAS) ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line Assessment will be done once every week for four weeks
Secondary Bolus saliva content at moment of swallowing (g/g dry product) Participants will be instructed to chew on pieces of until they feel the urge to swallow. At this point the participants will expectorate the sample into an aluminium cup. Saliva content of the bolus at time of swallowing will be measured by dry matter content analysis. The boli are expectorated on aluminium dishes, weighted and dried for 24 h at 110 °C, and weighted again after drying. Bite-size pieces of each bread as given to the participants will be dried and weighted as well to determine the initial moisture content of the breads. The saliva content (g/g dry product) will be calculated by subtracting the initial moisture content of the bread from the moisture content of the bolus. The moisture content will be calculated based on a dry weight basis using MC= (m0 - m1)/m1, where m0 is the weight before drying and m1 is the weight after drying. Assessment will be done once every week for four weeks
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