Eating BehaviorNCT05561426
Sustained Effect of Food Texture of Ultra-processed Foods on Energy Intake
A study testing Ad libitum breakfast and dinner meals for 12 days in people with Eating Behavior, run by Wageningen University at 1 site in Netherlands.
Trial summary
In this study the sustained effect of food texture differences (slow vs fast eating rate) of ultra-processed foods on energy intake and body composition changes will be investigated. 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?
- Ad libitum breakfast and dinner meals for 12 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Feb 2023to 14 Apr 2023
- 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
- Between 18-55 years old at the day of inclusion
- Able to understand and speak Dutch and English fluently or without difficulty (self-report)
- BMI 18.5-30 kg/m2 - measured by the researchers during the information meeting (after signing informed consent)
- Good general health and appetite (self-report)
- Commonly (5 out of 7 week days) eating three meals a day every day around approximately the same times (self-report)
Who cannot join
- 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)
- Braces (not including a dental wire) or oral piercing
- Smoking
- Consuming on average more than 21 glasses of alcohol per week
Show all 22Show fewer
- Not willing to stop using drugs during the study period (from inclusion till last test session)
- Use of medication that may influence study outcomes (self-report)
- Allergies or intolerance to any ingredient of the test meals
- Not willing to eat the test food because of eating habits, believes, or religion
- Following a vegetarian or vegan diet
- Lactose intolerant
- Men having facial hair such as a beard as facial movements cannot be analysed
- Followed an energy restricted diet during the last 2 months
- Gained or lost 5 kg of body weight over the last half year
- High restrained eater according to the Dutch Eating Behaviour Questionnaire (men: score>2.89, women>3.39) - this exclusion criterion will not explicitly be communicated to the participants to prevent desirable answers
- Signed up for participating in another research study of the Nutrition and Health department (WUR)
- Employee, thesis student or intern at the chair group of Sensory Science and Eating Behaviour Human Nutrition (WUR).
- Intensive exercising more than 5 hours per week
- Low score (<1) for liking the individual test meals on a nine point Likert scale based on pictures of the meals
- Unfamiliar with the test meals (self-report)
- Having an abnormal (non-representative) eating rates - measured by the researchers during the information meeting (after signing informed consent)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University, Human Nutrition Department
Wageningen, Gelderland, 6708 WE
About this study
In this study the sustained effect of food texture differences (slow vs fast eating rate) of ultra-processed foods on energy intake and body composition changes will be investigated.
Read the detailed description
Rationale: Several observational studies have shown that the consumption of ultra-processed foods (UPF) is associated with higher energy intake and obesity rates. However, the high eating rate of UPF might cause its high energy intake instead of the industrial processing level itself. There is a positive relationship between the eating rate and oro-sensory exposure of foods and subsequent energy intake. 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. So far, research on food texture and energy intake has only been performed for one meal or one day and it is unknown if food texture and eating rate have a sustained effect on energy intake. Knowledge on the sustained effect of food texture differences could be used for strategies to drive or limit energy intake.
Objective: The primary objective is to determine the sustained effect of food texture differences (slow vs fast eating rate) of UPF on energy intake. The secondary objective is to determine the effect of texture differences (slow vs fast eating rate) of UPF on body composition changes.
Study design: The study has a randomized crossover design with two treatment arms. All participants receive both conditions (1. slow test breakfast and dinners consisting of UPF and 2. fast test breakfast and dinners consisting of UPF for twelve subsequent days) and are their own control (within subject effects).
Study population: Healthy Dutch speaking adults (n=20) between 18-55 years old with a BMI between 18.5-30 kg/m2.
Intervention: Participants will join two test periods, each consisting out of twelve days. During the test periods they will visit the eating behaviour lab where they receive ad libitum breakfast and dinner meals. During meal consumption participants are video recorded to determine eating behaviour. Standardized fixed portion lunch meals and snacks will be provided on-the-go. On weekend days participants will receive pre-packed meals. In one test period participants will receive meals consisting of UPF that have a hard texture (slow eating rate) and in the other period (randomized order) they will receive meals consisting of UPF with a soft texture (fast eating rate). The order in which participants will receive the meals within each condition will be (block) randomized.
- Conditions
- Eating Behavior
- Being tested
- Ad libitum breakfast and dinner meals for 12 days
- Keywords
- Food texture, Ultra-processed foods, Food intake, Energy intake, Eating rate
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad libitum breakfast and dinner meals for 12 daysOther
Ad libitum portions of breakfast and dinner meals served at the eating behaviour lab
| Study group | Role | What they receive |
|---|---|---|
| Fast UPF meals | Experimental | Meals consisting of UPF with textures that are consumed fast Receives: Other: Ad libitum breakfast and dinner meals for 12 days |
| Slow UPF meals | Experimental | Meals consisting of UPF with textures that are consumed slow Receives: Other: Ad libitum breakfast and dinner meals for 12 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily energy intake (kcal/day)
Daily energy intake across 12 days for each diet
Measured: Two periods of 12 days
Secondary outcomes (7)
Body weight (kg)
Body weight (kg) measured using in duplicate using a weighing scale
Measured: Two periods of 12 days
Fat free mass measured with bioelectrical impedance analysis
Fat free mass measured with bioelectrical impedance analysis (kg and %)
Measured: Two periods of 12 days
Fat free mass measured with skinfold measurements
Fat free mass measured with skinfold measurements (kg and %)
Measured: Two periods of 12 days
Fat mass measured with bioelectrical impedance analysis
Fat mass measured wit bioelectrical impedance analysis (kg and %)
Measured: Two periods of 12 days
Fat mass measured with skinfold measurements
Fat mass measured with skinfold measurements (kg and %)
Measured: Two periods of 12 days
Waist and hip circumference (cm)
Waist and hip circumference will be measured in duplicate using measuring tape
Measured: Two periods of 12 days
BMI
Obtained by body weight (kg; measured using a weighing scale) and height (cm; measured using a stadiometer)
Measured: Two periods of 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start13 Feb 2023
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciaran Forde, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561426
- Sponsor's protocol ID
- PRESTRUCTURE
- Status last verified
- Apr 2023
- First submitted
- 20 Sep 2022
- Last updated
- 18 Apr 2023
- 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 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Effect of Food Texture of Ultra-processed Foods on Energy Intake
- ClinicalTrials.gov ID
- NCT05561426
- Acronym / sponsor ID
- PRESTRUCTURE
- Conditions
- Eating Behavior
- Keywords
- Food texture, Ultra-processed foods, Food intake, Energy intake, Eating rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 30 Sep 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.
In this study the sustained effect of food texture differences (slow vs fast eating rate) of ultra-processed foods on energy intake and body composition changes will be investigated.
Detailed description
Rationale: Several observational studies have shown that the consumption of ultra-processed foods (UPF) is associated with higher energy intake and obesity rates. However, the high eating rate of UPF might cause its high energy intake instead of the industrial processing level itself. There is a positive relationship between the eating rate and oro-sensory exposure of foods and subsequent energy intake. 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. So far, research on food texture and energy intake has only been performed for one meal or one day and it is unknown if food texture and eating rate have a sustained effect on energy intake. Knowledge on the sustained effect of food texture differences could be used for strategies to drive or limit energy intake.
Objective: The primary objective is to determine the sustained effect of food texture differences (slow vs fast eating rate) of UPF on energy intake. The secondary objective is to determine the effect of texture differences (slow vs fast eating rate) of UPF on body composition changes.
Study design: The study has a randomized crossover design with two treatment arms. All participants receive both conditions (1. slow test breakfast and dinners consisting of UPF and 2. fast test breakfast and dinners consisting of UPF for twelve subsequent days) and are their own control (within subject effects).
Study population: Healthy Dutch speaking adults (n=20) between 18-55 years old with a BMI between 18.5-30 kg/m2.
Intervention: Participants will join two test periods, each consisting out of twelve days. During the test periods they will visit the eating behaviour lab where they receive ad libitum breakfast and dinner meals. During meal consumption participants are video recorded to determine eating behaviour. Standardized fixed portion lunch meals and snacks will be provided on-the-go. On weekend days participants will receive pre-packed meals. In one test period participants will receive meals consisting of UPF that have a hard texture (slow eating rate) and in the other period (randomized order) they will receive meals consisting of UPF with a soft texture (fast eating rate). The order in which participants will receive the meals within each condition will be (block) randomized.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast UPF meals | Experimental | Other: Ad libitum breakfast and dinner meals for 12 daysMeals consisting of UPF with textures that are consumed fast |
| Slow UPF meals | Experimental | Other: Ad libitum breakfast and dinner meals for 12 daysMeals consisting of UPF with textures that are consumed slow |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between 18-55 years old at the day of inclusion
- Able to understand and speak Dutch and English fluently or without difficulty (self-report)
- BMI 18.5-30 kg/m2 - measured by the researchers during the information meeting (after signing informed consent)
- Good general health and appetite (self-report)
- Commonly (5 out of 7 week days) eating three meals a day every day around approximately the same times (self-report)
Key exclusion criteria (22 listed)
- 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)
- Braces (not including a dental wire) or oral piercing
- Smoking
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 |
|---|---|---|
| Ad libitum breakfast and dinner meals for 12 daysAd libitum portions of breakfast and dinner meals served at the eating behaviour lab | Other | Fast UPF meals, Slow UPF meals |
Primary outcome
Average daily energy intake (kcal/day)
Time frame: Two periods of 12 days
Daily energy intake across 12 days for each diet
7 secondary outcomes
Body weight (kg)
Time frame: Two periods of 12 days
Fat free mass measured with bioelectrical impedance analysis
Time frame: Two periods of 12 days
Fat free mass measured with skinfold measurements
Time frame: Two periods of 12 days
Fat mass measured with bioelectrical impedance analysis
Time frame: Two periods of 12 days
Fat mass measured with skinfold measurements
Time frame: Two periods of 12 days
Waist and hip circumference (cm)
Time frame: Two periods of 12 days
BMI
Time frame: Two periods of 12 days
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 18 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Eating Behavior
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
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 Ad libitum breakfast and dinner meals for 12 days 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 22 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 18 Apr 2023. 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?
Average daily energy intake (kcal/day) (time frame: Two periods of 12 days). 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 18 Apr 2023.