- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05019872
Al Dente or Well Done? The Eating Rate of a Pasta Meal Modified by Texture (ESPA)
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. However, the impact of texture on oral processing has mostly been studied as a model or single food system, whereas a diet consists of many different food products often consumed in combination. Little has been researched on the effect of food texture on eating rate within the context of realistic meals. It is not known if the eating rate of a meal is determined by the eating rate component with the lowest eating rate or if there is an additive effect of the eating rates of all components of the meal.
Objective: The aim of the ESPA study is to determine how the eating rate of a pasta meal can be changed by manipulating the hardness of the ingredients and to investigate if the eating rate of a meal is determined by the eating rate of the component with the lowest eating rate or if there is an additive effect of the eating rates of all components of the meal.
Study design: The study is a randomized crossover trial. All participants receive all pasta samples.
Study population: Healthy adults (n=50) between 18-55 years old with European nationality, and a BMI between 18.5-30 kg/m2.
Intervention: Participants will attend three test sessions during lunch in which in total twelve pasta samples will be consumed. The pasta samples will consists of individual or combined pasta noodles, vegetables, and sauce differing in hardness. The order of the samples will be randomized. After the consumption of the test samples, the participants will rate their appetite and the sensory characteristics of the samples. During the test sessions, participants will be video recorded to determine their eating behavior.
Main study parameters/endpoints: The main study outcome is the eating rate (g/min). Secondary outcomes are the oral processing characteristics assessed with the video recordings (meal duration [min], bite duration [min], number of bites, number of chews, average bite size [g], average amount of chews per bite, and oral sensory exposure time [min]) and sensory characteristics rated on a visual analogue scale (liking [flavor, texture, and overall], flavor intensity, sweetness, saltiness, sourness, hardness, and chewiness).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study has a randomized crossover design with three test sessions. All participants receive twelve pasta samples (four per test session) and are their own control (within subject effects).
Participants attend three test sessions during which they eat four pasta samples. The pasta samples will have a fixed amount and differ in pasta noodle and vegetable hardness. Eight pasta samples will consist out of only penne or carrots with or without sauce. Four pasta samples will consist out of penne, carrots, and sauce. The sample order will be randomized, but in each test session only one or two of sample 9 to 12 will be served. The samples will be served on a plate together with a fork.
Procedure of the study:
Throughout study period :
- No use of drugs
- Medication use + illness should be reported
Evening preceding test day:
• Not allowed to eat or drink after 22.00 except for water
Morning of test day:
- Do not perform intensive exercise
- Eat the same breakfast at the same time each test day
- If wanted, eat the same morning snack at the same time each test day
- Not allowed to eat or drink two hours prior the study session except for water
- Have a negative corona test
Lunch
- Give instructions (eat as you normally would do, eat the whole sample without taking breaks or sips of water in between, you can take a new bite before you swallowed the previous one)
- Seated at sensory booth with fork, knife, spoon, 200 mL of water and three pieces of a plain cracker
- Question about food consumption that morning
- Appetite questionnaire
- Eat the pasta sample (one of twelve conditions) while recording eating behavior
- Sensory questionnaire
- Appetite questionnaire
- Taste neutralization by waiting for two minutes, taking sip of water and bite of cracker
- Repeat * ... * until four pasta samples are consumed
- Appetite questionnaire
Participants will be recruited from Wageningen and surroundings using an e-mailing list, social media, and flyers. Healthy (self-report), normal weight (18.5-30 kg/m2) men and women between 18-55 years old will be included. Participants need to have European nationality, and have to be able to understand and speak English (self-report), because of the sensory questionnaire and appetite questionnaire which will be in English and have difficult direct translations to Dutch. As 90% of the people that show interest in the study are university students this should not be a problem. The BMI range is based on the average BMI in the Netherlands, which is 25 kg/m2 but around 50% of the Dutch population is overweight. To be able to include sufficient subjects it was therefore chosen to widen the BMI range and include people up to a BMI of 30 kg/m2. Due to the within subject design this will not influence the outcome of the study, but results will be more generalizable to people with an average weight.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gelderland
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Wageningen, Gelderland, Netherlands, 6708 WE
- Wageningen University, Human Nutrition Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Between 18-55 years old at the day of inclusion
- European nationality
- Able to understand and speak English fluently or without difficulty (self-report)
- BMI 18.5-30 kg/m2 (self-report)
- Good general health and appetite (self-report)
- Regular consumers of pasta with tomato sauce (commonly once or more per month)
Exclusion Criteria:
- Pregnant or lactating women
- Smoking
- Braces (not including a dental wire) or oral piercing
- Difficulties with swallowing, chewing and/or eating in general
- Suffering from an endocrine or eating disorder, gastrointestinal illness or illness of the thyroid gland, respiratory disease, or diabetes
- Having taste or smell disorders (self-report)
- Use of medication that may influence study outcomes (self-report)
- 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)
- Intensive exercising more than eight hours per week
- Allergies or intolerance to any ingredient of the test meals
- Don't like pasta with tomato sauce or its ingredients (<five on a nine point Likert scale)
- Men having facial hair such as a beard as facial movements cannot be analyzed
- 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 Human Nutrition or Food Quality and Design (WUR)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Penne hard
20 g penne cooked for 7 minutes
|
Samples will be provided one by one in cups labeled with an unique code.
|
Active Comparator: Penne soft
20 g penne cooked for 20 minutes
|
Samples will be provided one by one in cups labeled with an unique code.
|
Active Comparator: Carrot hard
50 g diced carrot cooked for 2 minutes
|
Samples will be provided one by one in cups labeled with an unique code.
|
Active Comparator: Carrot soft
50 g diced carrot cooked for 20 minutes
|
Samples will be provided one by one in cups labeled with an unique code.
|
Active Comparator: Penne hard + sauce
20 g penne cooked for 7 minutes + 10 g tomato sauce
|
Samples will be provided one by one in cups labeled with an unique code.
|
Active Comparator: Penne soft + sauce
20 g penne cooked for 20 minutes + 10 g tomato sauce
|
Samples will be provided one by one in cups labeled with an unique code.
|
Active Comparator: Carrot hard + sauce
50 g diced carrot cooked for 2 minutes + 10 g tomato sauce
|
Samples will be provided one by one in cups labeled with an unique code.
|
Active Comparator: Carrot soft + sauce
50 g diced carrot cooked for 20 minutes + 10 g tomato sauce
|
Samples will be provided one by one in cups labeled with an unique code.
|
Active Comparator: Penne hard + carrot hard + sauce
20 g penne cooked for 7 minutes + 50 g diced carrot cooked for 2 minutes + 20 g tomato sauce
|
Samples will be provided one by one in cups labeled with an unique code.
|
Active Comparator: Penne hard + carrot soft + sauce
20 g penne cooked for 7 minutes + 50 g diced carrot cooked for 20 minutes + 20 g tomato sauce
|
Samples will be provided one by one in cups labeled with an unique code.
|
Active Comparator: Penne soft + carrot hard + sauce
20 g penne cooked for 20 minutes + 50 g diced carrot cooked for 2 minutes + 20 g tomato sauce
|
Samples will be provided one by one in cups labeled with an unique code.
|
Active Comparator: Penne soft + carrot soft + sauce
20 g penne cooked for 20 minutes + 50 g diced carrot cooked for 20 minutes + 20 g tomato sauce
|
Samples will be provided one by one in cups labeled with an unique code.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eating rate (g/min)
Time Frame: 1 sample, up to 30 minutes
|
Amount of the sample divided by the consumption time of the sample, measured with video recording.
|
1 sample, up to 30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Meal duration (min)
Time Frame: 1 sample, up to 30 minutes
|
Time to consume one sample, measured with video recording.
|
1 sample, up to 30 minutes
|
Bite duration (min)
Time Frame: 1 sample, up to 30 minutes
|
Measured with video recording.
|
1 sample, up to 30 minutes
|
Number of bites
Time Frame: 1 sample, up to 30 minutes
|
Measured with video recording.
|
1 sample, up to 30 minutes
|
Number of chews
Time Frame: 1 sample, up to 30 minutes
|
Measured with video recording.
|
1 sample, up to 30 minutes
|
Average bite size (g)
Time Frame: 1 sample, up to 30 minutes
|
Measured with video recording.
|
1 sample, up to 30 minutes
|
Chews per bite
Time Frame: 1 sample, up to 30 minutes
|
Measured with video recording.
|
1 sample, up to 30 minutes
|
Oro-sensory exposure time (min)
Time Frame: 1 sample, up to 30 minutes
|
Measured with video recording.
|
1 sample, up to 30 minutes
|
Liking flavour
Time Frame: 1 sample, up to 30 minutes
|
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
|
1 sample, up to 30 minutes
|
Liking texture
Time Frame: 1 sample, up to 30 minutes
|
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
|
1 sample, up to 30 minutes
|
Liking overall
Time Frame: 1 sample, up to 30 minutes
|
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
|
1 sample, up to 30 minutes
|
Sweetness
Time Frame: 1 sample, up to 30 minutes
|
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
|
1 sample, up to 30 minutes
|
Saltiness
Time Frame: 1 sample, up to 30 minutes
|
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
|
1 sample, up to 30 minutes
|
Sourness
Time Frame: 1 sample, up to 30 minutes
|
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
|
1 sample, up to 30 minutes
|
Hardness
Time Frame: 1 sample, up to 30 minutes
|
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
|
1 sample, up to 30 minutes
|
Chewiness
Time Frame: 1 sample, up to 30 minutes
|
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
|
1 sample, up to 30 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lise AJ Heuven, MSc, Wageningen University
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SEC WUR 2021
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
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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