- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05615350
The Effect of Meal Texture on Intake
Study Overview
Status
Conditions
Detailed Description
Rationale: Food texture modifies eating rate and through that the energy intake of foods. It is shown that harder, chunkier, more viscous, and more voluminous foods decrease eating rate of foods and thus decrease energy intake. However, most research is done in model foods or single foods. So far, little research on food texture and intake has been performed for meals. It is not known what the effect of food texture and eating rate is on intake in a wide variety of meals. Knowledge on the effect of food texture on intake could be used for strategies to drive or limit energy intake.
Objective: The objective is to determine how a wide range of different food textures influence energy intake, food intake, and eating behaviour.
Study design: All participants receive all twelve different meals (within subject design). The meals are either served during breakfast or lunch. The meals have a wide range of different food textures. Participants consume the meals ad libitum twice per week for six weeks long with at least two days in between.
Study population: Healthy Dutch speaking adults (n=30) between 18-55 years old with a BMI between 18.5-30 kg/m2.
Intervention: Participants will join twelve test sessions. For the test sessions they will visit the eating behaviour lab where they receive ad libitum meals during breakfast or lunch. During meal consumption participants are video recorded to determine eating behaviour. The participants will receive in total twelve meals. The order in which participants will receive the meals will be block randomized (block n = 5).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gelderland
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Wageningen, Gelderland, Netherlands, 6708 WE
- Wageningen University, Human Nutrition Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Generally healthy
- Good appetite
- Between 18 and 55 years old
- Speak and understand English without difficulty
- BMI between 18.5-30 kg/m2.
- Non-smoker
- Commonly (5 out of 7 week days) eat three meals a day every day around the
Exclusion Criteria:
- Have difficulties with swallowing, chewing, and/or eating in general;
- Are suffering from an endocrine or eating disorder, gastrointestinal illness or illness of the thyroid gland, respiratory disease, or diabetes
- Have taste or smell disorders
- Have braces or oral piercing (dental wire behind teeth is allowed)
- are smoking
- Consume on average more than 21 glasses of alcohol per week
- Are not willing to stop using drugs during the study period (from inclusion till last test session)
- Use medication that may influence study outcomes
- Have allergies or intolerance to any ingredient of the test meals
- Are not willing to eat the test food because of eating habits, believes, or religion
- Follow a vegetarian or vegan diet
- Are lactose intolerant
- Have facial hair such as a beard
- Follow an energy restricted diet during the last 2 months
- Gained or lost 5 kg of body weight over the last half year
- Are an employee, thesis student or intern at the chair group of Sensory Science and Eating Behaviour Human Nutrition (WUR).
- Do intensive exercising more than 8 hours per week
- Low score (<1) for liking the individual test meals on a nine point Likert scale based on pictures of the meals
- Familiar with at least 75% of the test meals (self-report)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Meals served during breakfast
Twice a week for six weeks (in total twelve times) participants will consume meals ad libitum during breakfast.
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Ad libitum portions of twelve different meals with a wide range of food textures served during breakfast at the eating behaviour lab
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Experimental: Meals served during lunch
Twice a week for six weeks (in total twelve times) participants will consume meals ad libitum during lunch.
They will receive a standardized breakfast meal.
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Ad libitum portions of twelve different meals with a wide range of food textures served during lunch at the eating behaviour lab
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy intake (kcal)
Time Frame: 6 weeks
|
Energy intake (kcal) of each meal
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6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food intake (g)
Time Frame: 6 weeks
|
Food intake (g) of each meal
|
6 weeks
|
|
Eating rate (g/min)
Time Frame: 6 weeks
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Eating rate (g/min) measured with video recording and automated video analysis
|
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BMI
Time Frame: 5 minutes
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Obtained by body weight (kg; measured using a weighing scale) and height (cm; measured using a stadiometer) as assessed during screening
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5 minutes
|
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Subjective hunger
Time Frame: 6 weeks
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Hunger measured before and after meal consumption on 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
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6 weeks
|
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Subjective fullness
Time Frame: 6 weeks
|
Fullness measured before and after meal consumption on 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
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6 weeks
|
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Subjective desire to eat
Time Frame: 6 weeks
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Desire to eat measured before and after meal consumption on 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
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6 weeks
|
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Liking
Time Frame: 6 weeks
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Liking of meals after one bite and after meal consumption will be rated on a 100-mm Visual Analogue Scale (VAS) ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
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6 weeks
|
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Flavour intensity
Time Frame: 6 weeks
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Flavour intensity after one bite will be rated on a 100-mm Visual Analogue Scale (VAS) ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
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6 weeks
|
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Subjective prospective consumption
Time Frame: 6 weeks
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Prospective consumption measured before and after meal consumption on 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
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6 weeks
|
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Hardness
Time Frame: 6 weeks
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Hardness after one bite will be rated on a 100-mm Visual Analogue Scale (VAS) ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
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6 weeks
|
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Thickness
Time Frame: 6 weeks
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Thickness after one bite will be rated on a 100-mm Visual Analogue Scale (VAS) ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
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6 weeks
|
|
Dryness
Time Frame: 6 weeks
|
Dryness after one bite will be rated on a 100-mm Visual Analogue Scale (VAS) ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
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6 weeks
|
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Familiarity
Time Frame: 6 weeks
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Familiarity (after one bite and after the meal) will be rated on a 9 point Likert scale
|
6 weeks
|
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Expected satiation
Time Frame: 6 weeks
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Expected satiation (after one bite) will be rated on a 100-mm Visual Analogue Scale (VAS) ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
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6 weeks
|
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Desire to eat the meal
Time Frame: 6 weeks
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Desire to eat the meal (after one bite and after the meal) will be rated on a 100-mm Visual Analogue Scale (VAS) ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
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6 weeks
|
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Reasons for eating cessation
Time Frame: 6 weeks
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Reasons for eating cessation assessed with the Reasons Individuals Stop Eating Questionnaire (RISE-Q)
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6 weeks
|
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Self-reported eating rate
Time Frame: 1 minute
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Self-reported eating rate measured using the question "How would you describe your eating rate compared with others?" which can be answered on a five-point Likert scale ('very slow', 'slow', 'average', 'fast' or 'very fast')
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1 minute
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Restrained eating, emotional eating and external eating
Time Frame: 30 minutes
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The level of restrained, emotional, and external eating assessed with the Dutch Eating Behaviour Questionnaire (DEBQ) consisting out of 33 questions.
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30 minutes
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CONSTRUCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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