NCT05185765

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 25, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2021

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

1 month

First QC Date

December 2, 2021

Last Update Submit

January 10, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Overall liking

    Assessment will be done once every week for four weeks

  • Crumb hardness

    Assessment will be done once every week for four weeks

  • Crumb dryness

    Assessment will be done once every week for four weeks

  • Crumb chewiness

    Assessment will be done once every week for four weeks

  • Crumb adhesiveness

    Assessment will be done once every week for four weeks

  • +5 more secondary outcomes

Study Arms (16)

Brown bread (commercially available)

ACTIVE COMPARATOR

Participants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part

Other: Bread

Wholemeal bread (commercially available)

ACTIVE COMPARATOR

Participants consume half a slice, and masticate and expectorate 1/4th of rectangular bottom part

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

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

Other: Bread

White hard roll (commercially available)

ACTIVE COMPARATOR

Participants consume half a roll, and masticate and expectorate half of 1 cm thick slice

Other: Bread

Brown hard roll (commercially available)

ACTIVE COMPARATOR

Participants consume half a roll, and masticate and expectorate half of 1 cm thick slice

Other: Bread

White soft bun (commercially available)

ACTIVE COMPARATOR

Participants consume half a bun, and masticate and expectorate 1/8th of a bun

Other: Bread

Brown soft bun (commercially available)

ACTIVE COMPARATOR

Participants consume half a bun, and masticate and expectorate 1/8th of a bun

Other: Bread

Ciabatta (commercially available)

ACTIVE COMPARATOR

Participants consume half a mini ciabatta, and masticate and expectorate half of 1 cm thick slice

Other: Bread

Croissant (commercially available)

ACTIVE COMPARATOR

Participants consume half a croissant, and masticate and expectorate half of 1 cm thick slice

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

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

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

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

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

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

Other: Bread

Interventions

BreadOTHER

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

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 coolingWhole wheat bread produced by bakery, proofing time 105 min, vacuum coolingWhole wheat bread produced by bakery, proofing time 65 min, ambient coolingWhole wheat bread produced by bakery, proofing time 65 min, vacuum coolingWhole wheat bread produced by bakery, proofing time 85 min, ambient coolingWhole wheat bread produced by bakery, proofing time 85 min, vacuum coolingWholemeal bread (commercially available)Wholemeal bread without crust (commercially available)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good general health and appetite (self-report)
  • Dutch
  • BMI 18.5-30 kg/m2 (self-report)
  • Regular consumer of bread

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, Gelderland, 6708 WG, Netherlands

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

Bread

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2021

First Posted

January 11, 2022

Study Start

October 25, 2021

Primary Completion

December 3, 2021

Study Completion

December 3, 2021

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations