Eating BehaviorBOPNCT05185765
An Application of Models Predicting the Eating Rate of Bread Using Sensory and Instrumental Texture
A study testing Bread in people with Eating Behavior, run by Wageningen University at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior
- What is being tested?
- Bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Oct 2021to 3 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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).
- Conditions
- Eating Behavior
- Being tested
- Bread
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreadOther
Samples will be provided one by one labeled with an unique code. The mastication and expectorated sample will be given in replicate.
| Study group | Role | What they receive |
|---|---|---|
| Brown bread (commercially available) | Active comparator | Participants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part Receives: Other: Bread |
| Wholemeal bread (commercially available) | Active comparator | Participants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part Receives: Other: Bread |
| Wholemeal bread without crust (commercially available) | Active comparator | Participants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part Receives: Other: Bread |
| White bread, water based (commercially available) | Active comparator | Participants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part Receives: Other: Bread |
| White hard roll (commercially available) | Active comparator | Participants consume half a roll, and masticate and expectorate half of 1 cm thick slice Receives: Other: Bread |
| Brown hard roll (commercially available) | Active comparator | Participants consume half a roll, and masticate and expectorate half of 1 cm thick slice Receives: Other: Bread |
| White soft bun (commercially available) | Active comparator | Participants consume half a bun, and masticate and expectorate 1/8th of a bun Receives: Other: Bread |
| Brown soft bun (commercially available) | Active comparator | Participants consume half a bun, and masticate and expectorate 1/8th of a bun Receives: Other: Bread |
| Ciabatta (commercially available) | Active comparator | Participants consume half a mini ciabatta, and masticate and expectorate half of 1 cm thick slice Receives: Other: Bread |
| Croissant (commercially available) | Active comparator | Participants consume half a croissant, and masticate and expectorate half of 1 cm thick slice Receives: Other: Bread |
| Whole wheat bread produced by bakery, proofing time 65 min, ambient cooling | Active comparator | Participants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part Receives: Other: Bread |
| Whole wheat bread produced by bakery, proofing time 85 min, ambient cooling | Active comparator | Participants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part Receives: Other: Bread |
| Whole wheat bread produced by bakery, proofing time 105 min, ambient cooling | Active comparator | Participants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part Receives: Other: Bread |
| Whole wheat bread produced by bakery, proofing time 65 min, vacuum cooling | Active comparator | Participants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part Receives: Other: Bread |
| Whole wheat bread produced by bakery, proofing time 85 min, vacuum cooling | Active comparator | Participants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part Receives: Other: Bread |
| Whole wheat bread produced by bakery, proofing time 105 min, vacuum cooling | Active comparator | Participants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part Receives: Other: Bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating rate (g/min)
Amount of the sample divided by the consumption time of the sample, measured with video recording
Measured: Up to 30 minutes
Secondary outcomes (10)
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
Measured: Assessment will be done once every week for four weeks
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
Measured: Assessment will be done once every week for four weeks
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
Measured: Assessment will be done once every week for four weeks
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
Measured: Assessment will be done once every week for four weeks
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
Measured: Assessment will be done once every week for four weeks
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
Measured: Assessment will be done once every week for four weeks
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
Measured: Assessment will be done once every week for four weeks
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
Measured: Assessment will be done once every week for four weeks
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
Measured: Assessment will be done once every week for four weeks
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.
Measured: Assessment will be done once every week for four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start25 Oct 2021
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185765
- Sponsor's protocol ID
- BOP.study
- Acronym
- BOP
- Status last verified
- Jan 2022
- First submitted
- 2 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Application of Models Predicting the Eating Rate of Bread Using Sensory and Instrumental Texture
- ClinicalTrials.gov ID
- NCT05185765
- Acronym / sponsor ID
- BOP / BOP.study
- Conditions
- Eating Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Brown bread (commercially available) | Active comparator | Other: BreadParticipants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part |
| Wholemeal bread (commercially available) | Active comparator | Other: BreadParticipants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part |
| Wholemeal bread without crust (commercially available) | Active comparator | Other: BreadParticipants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part |
| White bread, water based (commercially available) | Active comparator | Other: BreadParticipants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part |
| White hard roll (commercially available) | Active comparator | Other: BreadParticipants consume half a roll, and masticate and expectorate half of 1 cm thick slice |
| Brown hard roll (commercially available) | Active comparator | Other: BreadParticipants consume half a roll, and masticate and expectorate half of 1 cm thick slice |
| White soft bun (commercially available) | Active comparator | Other: BreadParticipants consume half a bun, and masticate and expectorate 1/8th of a bun |
| Brown soft bun (commercially available) | Active comparator | Other: BreadParticipants consume half a bun, and masticate and expectorate 1/8th of a bun |
| Ciabatta (commercially available) | Active comparator | Other: BreadParticipants consume half a mini ciabatta, and masticate and expectorate half of 1 cm thick slice |
| Croissant (commercially available) | Active comparator | Other: BreadParticipants consume half a croissant, and masticate and expectorate half of 1 cm thick slice |
| Whole wheat bread produced by bakery, proofing time 65 min, ambient cooling | Active comparator | Other: BreadParticipants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part |
| Whole wheat bread produced by bakery, proofing time 85 min, ambient cooling | Active comparator | Other: BreadParticipants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part |
| Whole wheat bread produced by bakery, proofing time 105 min, ambient cooling | Active comparator | Other: BreadParticipants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part |
| Whole wheat bread produced by bakery, proofing time 65 min, vacuum cooling | Active comparator | Other: BreadParticipants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part |
| Whole wheat bread produced by bakery, proofing time 85 min, vacuum cooling | Active comparator | Other: BreadParticipants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part |
| Whole wheat bread produced by bakery, proofing time 105 min, vacuum cooling | Active comparator | Other: BreadParticipants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BreadSamples will be provided one by one labeled with an unique code. The mastication and expectorated sample will be given in replicate. | Other | Brown bread (commercially available), Brown hard roll (commercially available), Brown soft bun (commercially available), Ciabatta (commercially available), Croissant (commercially available), White bread, water based (commercially available), White hard roll (commercially available), White soft bun (commercially available), Whole wheat bread produced by bakery, proofing time 105 min, ambient cooling, Whole wheat bread produced by bakery, proofing time 105 min, vacuum cooling, Whole wheat bread produced by bakery, proofing time 65 min, ambient cooling, Whole wheat bread produced by bakery, proofing time 65 min, vacuum cooling, Whole wheat bread produced by bakery, proofing time 85 min, ambient cooling, Whole wheat bread produced by bakery, proofing time 85 min, vacuum cooling, Wholemeal bread (commercially available), Wholemeal bread without crust (commercially available) |
Primary outcome
Eating rate (g/min)
Time frame: Up to 30 minutes
Amount of the sample divided by the consumption time of the sample, measured with video recording
10 secondary outcomes
Overall liking
Time frame: Assessment will be done once every week for four weeks
Crumb hardness
Time frame: Assessment will be done once every week for four weeks
Crumb dryness
Time frame: Assessment will be done once every week for four weeks
Crumb chewiness
Time frame: Assessment will be done once every week for four weeks
Crumb adhesiveness
Time frame: Assessment will be done once every week for four weeks
Crumb denseness
Time frame: Assessment will be done once every week for four weeks
Crust hardness
Time frame: Assessment will be done once every week for four weeks
Crust crispiness
Time frame: Assessment will be done once every week for four weeks
Crust crumbliness
Time frame: Assessment will be done once every week for four weeks
Bolus saliva content at moment of swallowing (g/g dry product)
Time frame: Assessment will be done once every week for four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bread in people with Eating Behavior, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating rate (g/min) (time frame: Up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.