Eating RateNCT06113146
Impact of the Eating Rate of Ultra-processed Foods on Dietary Intake Behavior and Metabolic Responses
A study testing ultra-processed slow eating rate diet and Ultra-processed fast eating rate diet in people with Eating Rate, run by Wageningen University at 1 site in Netherlands.
Trial summary
The aim of this balanced-order block randomized controlled cross-over trial with 2 treatment arms is to determine the effect of eating rate (ER) of ultra-processed food diets (UPF fast ER vs UPF slow ER) on ad libitum energy intake across a two week period. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Rate
- What is being tested?
- ultra-processed slow eating rate diet and Ultra-processed fast eating rate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Oct 2023to 4 Nov 2024
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Haemoglobin value is not between 7.5-11.0 mmol/L (women), 8.5-11.0 mmol/L (men)
- Fasted glucose level is below < 3.5 mmol/L or higher than 8 mmol/L
- Blood pressure is below 90/60 mm hg (below 90 and/or below 60 mm hg)
- Veins are not suited for blood sampling (as judged by trained research nurses)
- Persons with an extremely fast or slow eating rate trait, (> 2 times the SD from the median, based on the carrot test [26] eating rate distribution based on data collected in previous studies in the same study population (unpublished).
- Persons with little difference (< 20%) in the eating rate of a hard or soft carrot
- Do not like > 20% of the test foods based tasting small portions (1 bite) of each of the meals (scoring items below ≤ dislike on a nine point hedonic scale)* * This exclusion criterion will not explicitly be communicated to the participants to prevent desirable answers
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this balanced-order block randomized controlled cross-over trial with 2 treatment arms is to determine the effect of eating rate (ER) of ultra-processed food diets (UPF fast ER vs UPF slow ER) on ad libitum energy intake across a two week period.
Read the detailed description
Rationale: Consumption of industrially processed foods has been associated with obesity and related adverse health outcomes. If this reflects a causal relationship, it is unknown what attributes or properties of industrially processed foods might drive this association. Extensive research has shown that foods consumed with a texture-derived slow eating rate (ER) are consumed in smaller amounts relative to foods consumed with a fast ER. ER has been suggested as one of the mechanisms why (ultra-)processed foods (with a fast ER) may promote excess in calorie intakes. We will therefore test the hypothesis that ER moderates energy intakes from ultra-processed foods.
Objective: The primary objective of this study is to determine the effect of ER of ultra-processed food diets (UPF slow ER vs UPF fast ER) on ad libitum energy intake (kcal/day) across a two week period. The secondary objectives are to compare body composition and metabolic changes that occur when on a 14 day diet of ultra-processed foods with either a slow or a fast ER.
Study design: We will conduct a balanced-order, block randomized controlled cross-over trial with 2 treatment arms, to determine the effect of ER of ultra-processed food diets (UPF fast ER vs UPF slow ER) on ad libitum energy intake (kcal) across a two week period. The study will have a run-in period to determine habitual dietary habits (baseline) and a washout period (14 days) between treatments to prevent carry-over effects. All participants will receive both treatments and are their own control (within subject design).
Study population: 39 healthy, non-smoking, adults between 21-50 years old and with a BMI between 21-27 kg/m2 will be included.
Intervention: The two treatments are 1) a 14-days ultra-processed, slow ER diet, and 2) a 14-days ultra-processed, fast ER diet. The ad libitum meal menus are matched for energy density (kcal/g), liking (hedonic range), and level of processing, but different in textural characteristics known to influence ER. During the treatment periods participants eat all of their main meals at the research site on weekdays. Participants receive pre-packed meals to consume at home for the weekends. Meals are served ad-libitum, presented in portions that are > 200% of a regular portion size. Participants are asked to eat from each meal until they feel comfortably full. Food (gram) and energy (kcal) consumed will be recorded at the level of the meal, the day and week of the interventions.
Main study parameters/endpoints: The primary outcome is the between-treatment difference in average (across 14 days) daily energy intake (kcal/day). Secondary study parameters include between-treatment differences in: food intake (g/day), body weight and body composition changes, postprandial hormone responses and respiratory quotient changes to a mixed meal tolerance test, continuous measures of glucose levels, and changes in fasted state leptin and ghrelin levels and blood lipid profiles.
- Conditions
- Eating Rate
- Being tested
- ultra-processed slow eating rate diet, Ultra-processed fast eating rate diet
- Keywords
- Eating rate, Food texture, Eating behaviour, Ultra-Processed Foods, Metabolism
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultra-processed slow eating rate dietOther
Consuming ultra-processed slow eating rate meals (served ad libitum) and snacks. Eating rate is manipulated through food texture, for example foods with a hard texture that require a long chewing duration before a bite of food can be swallowed.
Ultra-processed fast eating rate dietOther
Consuming ultra-processed fast eating rate meals (served ad libitum) and snacks. Eating rate is manipulated through food texture, for example foods with a soft texture that require little chewing before a bite of food can be swallowed.
| Study group | Role | What they receive |
|---|---|---|
| ultra-processed slow eating rate diet then the ultra-processed fast eating rate diet | Experimental | Participants assigned to this arm will receive an ultra-processed slow eating rate diet for two weeks, followed by a two week washout period and a two week ultra-processed fast eating rate diet. Receives: Other: ultra-processed slow eating rate diet; Other: Ultra-processed fast eating rate diet |
| ultra-processed fast eating rate diet then the ultra-processed slow eating rate diet | Experimental | Participants assigned to this arm will receive an ultra-processed fast eating rate diet for two weeks, followed by a two week washout period and a two week ultra-processed slow eating rate diet. Receives: Other: ultra-processed slow eating rate diet; Other: Ultra-processed fast eating rate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily energy intake (kcal/day)
The average (across two weeks) daily energy intake (kcal/day) in each diet arm
Measured: Two periods of 14 days
Secondary outcomes (11)
Total Energy intake (kcal)
Ad libitum energy intake (kcal) per meal, day and week.
Measured: Two periods of 14 days
Total Food intake (gram)
Ad libitum food intake (gram) per meal, day, week and average daily food intake (gram/day) in each diet arm.
Measured: Two periods of 14 days
Cumulative energy intake (kcal)
Cumulative energy intake (kcal) over the study period (14 days)
Measured: Two periods of 14 days
Cumulative food intake (gram)
Cumulative food intake (gram) over the study period (14 days)
Measured: Two periods of 14 days
Body weight (kg)
Participant's weight will be measured in duplicate to obtain an average. The participant will be measured in stocking feet and light clothing on a standard balance scale. Participant will not be able to see their weight.
Measured: Pre and post intervention periods and six times (every other day) during each intervention period of 14 days
Total and Regional Fat Mass and Fat Free Mass (kg, %)
Changes in fat mass and fat free mass (kg, %) will be measured using; DEXA, air displacement plethysmography (BODPOD), skinfold measurements
Measured: Pre and post 14-day intervention periods
Postprandial hormone responses (Mixed Meal Tolerance Test)
Insulin and glucose, total ghrelin, total GLP-1, PP, PYY, Glucagon and c-peptide responses, to a fixed calorie test meal (rice porridge)
Measured: Baseline and post 14-day intervention periods
Metabolic outcomes (Mixed Meal Tolerance Test)
Resting energy expenditure will be measured 30 minutes before a Mixed Meal Tolerance Test (MMTT) consisting of a fixed energy amount of rice porridge, and 30 minutes immediately after the meal using a ventilated hood. Based on this we will estimate the respiratory quotient, diet induced thermogenesis and substrate use. Based on the resting energy expenditure in combination with physical activity levels (estimated based on accelerometer (actigraphy) and 24hr recalls of exercise/sports) energy expenditure will be calculated per participant.
Measured: Baseline and post 14-day intervention periods
Glucose Excursions
24-hour glucose levels will be measured using Continuous Glucose Monitoring (CGM). This will be used for a comparison of percentage of time spent within and out of the normative range.
Measured: Every 15 minutes throughout two 14-day intervention periods
Leptin and Ghrelin levels (Fasted state)
Leptin, Ghrelin blood plasma concentrations after an overnight fast
Measured: Baseline and post 14-day intervention periods
Blood lipid profile (Fasted state)
Total cholesterol, HDL, LDL, free fatty acids and other blood lipids
Measured: Baseline and post 14-day intervention periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start2 Oct 2023
- Primary completion4 Nov 2024
- Study completion4 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Eating RateStudies 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
- Model description
- The study is a balanced-order, block randomized controlled cross-over trial with 2 treatment arms. The study will have a run-in period to determine dietary habits at baseline and a washout period (14 days) to prevent carry-over effects. All participants will receive both treatments and are their own control (within participant design).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Next Food Collective (previously TKI agri-food program and TiFN, Top Institute Food and Nutrition)
- Responsible party
- Principal investigator, Ciaran Forde, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113146
- Sponsor's protocol ID
- RESTRUCTURE- Revamp Study
- Status last verified
- Jun 2024
- First submitted
- 18 Oct 2023
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available according to the FAIR principles on Open Science Framework (OSF)
Publications
van Bruinessen M, Liu Z, Heuven LAJ, Stieger M, Lasschuijt MP, Forde CG. Satiety responsiveness following dietary exposure to ultra-processed foods differing in texture-derived eating rate: a secondary analysis of a randomized controlled crossover diet intervention. Eur J Nutr. 2026 Sep 24;65(7):261. doi: 10.1007/s00394-026-04111-7.
PubMed 42782361Forde CG, Heuven LA, van Bruinessen M, Liu Z, Stieger M, de Graaf K, Lasschuijt MP. Eating rate has sustained effects on energy intake from ultraprocessed diets: a 2-week ad libitum dietary randomized controlled crossover trial. Am J Clin Nutr. 2026 Apr;123(4):101122. doi: 10.1016/j.ajcnut.2025.11.012. Epub 2025 Nov 26.
PubMed 41314613Lasschuijt MP, Heuven LAJ, van Bruinessen M, Liu Z, Rubert J, Stieger M, de Graaf K, Forde CG. The Effect of Eating Rate of Ultra-Processed Foods on Dietary Intake, Eating Behaviour, Body Composition and Metabolic Responses-Rationale, Design and Outcomes of the Restructure Randomised Controlled Trial. Nutr Bull. 2025 Dec;50(4):640-655. doi: 10.1111/nbu.70027. Epub 2025 Sep 9.
PubMed 40926558
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Eating Rate of Ultra-processed Foods on Dietary Intake Behavior and Metabolic Responses
- ClinicalTrials.gov ID
- NCT06113146
- Acronym / sponsor ID
- RESTRUCTURE- Revamp Study
- Conditions
- Eating Rate
- Keywords
- Eating rate, Food texture, Eating behaviour, Ultra-Processed Foods, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Next Food Collective (previously TKI agri-food program and TiFN, Top Institute Food and Nutrition)
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 2 Nov 2023 (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.
The aim of this balanced-order block randomized controlled cross-over trial with 2 treatment arms is to determine the effect of eating rate (ER) of ultra-processed food diets (UPF fast ER vs UPF slow ER) on ad libitum energy intake across a two week period.
Detailed description
Rationale: Consumption of industrially processed foods has been associated with obesity and related adverse health outcomes. If this reflects a causal relationship, it is unknown what attributes or properties of industrially processed foods might drive this association. Extensive research has shown that foods consumed with a texture-derived slow eating rate (ER) are consumed in smaller amounts relative to foods consumed with a fast ER. ER has been suggested as one of the mechanisms why (ultra-)processed foods (with a fast ER) may promote excess in calorie intakes. We will therefore test the hypothesis that ER moderates energy intakes from ultra-processed foods.
Objective: The primary objective of this study is to determine the effect of ER of ultra-processed food diets (UPF slow ER vs UPF fast ER) on ad libitum energy intake (kcal/day) across a two week period. The secondary objectives are to compare body composition and metabolic changes that occur when on a 14 day diet of ultra-processed foods with either a slow or a fast ER.
Study design: We will conduct a balanced-order, block randomized controlled cross-over trial with 2 treatment arms, to determine the effect of ER of ultra-processed food diets (UPF fast ER vs UPF slow ER) on ad libitum energy intake (kcal) across a two week period. The study will have a run-in period to determine habitual dietary habits (baseline) and a washout period (14 days) between treatments to prevent carry-over effects. All participants will receive both treatments and are their own control (within subject design).
Study population: 39 healthy, non-smoking, adults between 21-50 years old and with a BMI between 21-27 kg/m2 will be included.
Intervention: The two treatments are 1) a 14-days ultra-processed, slow ER diet, and 2) a 14-days ultra-processed, fast ER diet. The ad libitum meal menus are matched for energy density (kcal/g), liking (hedonic range), and level of processing, but different in textural characteristics known to influence ER. During the treatment periods participants eat all of their main meals at the research site on weekdays. Participants receive pre-packed meals to consume at home for the weekends. Meals are served ad-libitum, presented in portions that are > 200% of a regular portion size. Participants are asked to eat from each meal until they feel comfortably full. Food (gram) and energy (kcal) consumed will be recorded at the level of the meal, the day and week of the interventions.
Main study parameters/endpoints: The primary outcome is the between-treatment difference in average (across 14 days) daily energy intake (kcal/day). Secondary study parameters include between-treatment differences in: food intake (g/day), body weight and body composition changes, postprandial hormone responses and respiratory quotient changes to a mixed meal tolerance test, continuous measures of glucose levels, and changes in fasted state leptin and ghrelin levels and blood lipid profiles.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a balanced-order, block randomized controlled cross-over trial with 2 treatment arms. The study will have a run-in period to determine dietary habits at baseline and a washout period (14 days) to prevent carry-over effects. All participants will receive both treatments and are their own control (within participant design).
| Arm | Type | Receives |
|---|---|---|
| ultra-processed slow eating rate diet then the ultra-processed fast eating rate diet | Experimental | Other: ultra-processed slow eating rate diet, Other: Ultra-processed fast eating rate dietParticipants assigned to this arm will receive an ultra-processed slow eating rate diet for two weeks, followed by a two week washout period and a two week ultra-processed fast eating rate diet. |
| ultra-processed fast eating rate diet then the ultra-processed slow eating rate diet | Experimental | Other: ultra-processed slow eating rate diet, Other: Ultra-processed fast eating rate dietParticipants assigned to this arm will receive an ultra-processed fast eating rate diet for two weeks, followed by a two week washout period and a two week ultra-processed slow eating rate diet. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Haemoglobin value is not between 7.5-11.0 mmol/L (women), 8.5-11.0 mmol/L (men)
- Fasted glucose level is below < 3.5 mmol/L or higher than 8 mmol/L
- Blood pressure is below 90/60 mm hg (below 90 and/or below 60 mm hg)
- Veins are not suited for blood sampling (as judged by trained research nurses)
- Persons with an extremely fast or slow eating rate trait, (> 2 times the SD from the median, based on the carrot test [26] eating rate distribution based on data collected in previous studies in the same study population (unpublished).
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 |
|---|---|---|
| ultra-processed slow eating rate dietConsuming ultra-processed slow eating rate meals (served ad libitum) and snacks. Eating rate is manipulated through food texture, for example foods with a hard texture that require a long chewing duration before a bite of food can be swallowed. | Other | ultra-processed fast eating rate diet then the ultra-processed slow eating rate diet, ultra-processed slow eating rate diet then the ultra-processed fast eating rate diet |
| Ultra-processed fast eating rate dietConsuming ultra-processed fast eating rate meals (served ad libitum) and snacks. Eating rate is manipulated through food texture, for example foods with a soft texture that require little chewing before a bite of food can be swallowed. | Other | ultra-processed fast eating rate diet then the ultra-processed slow eating rate diet, ultra-processed slow eating rate diet then the ultra-processed fast eating rate diet |
Primary outcome
Average daily energy intake (kcal/day)
Time frame: Two periods of 14 days
The average (across two weeks) daily energy intake (kcal/day) in each diet arm
11 secondary outcomes
Total Energy intake (kcal)
Time frame: Two periods of 14 days
Total Food intake (gram)
Time frame: Two periods of 14 days
Cumulative energy intake (kcal)
Time frame: Two periods of 14 days
Cumulative food intake (gram)
Time frame: Two periods of 14 days
Body weight (kg)
Time frame: Pre and post intervention periods and six times (every other day) during each intervention period of 14 days
Total and Regional Fat Mass and Fat Free Mass (kg, %)
Time frame: Pre and post 14-day intervention periods
Postprandial hormone responses (Mixed Meal Tolerance Test)
Time frame: Baseline and post 14-day intervention periods
Metabolic outcomes (Mixed Meal Tolerance Test)
Time frame: Baseline and post 14-day intervention periods
Glucose Excursions
Time frame: Every 15 minutes throughout two 14-day intervention periods
Leptin and Ghrelin levels (Fasted state)
Time frame: Baseline and post 14-day intervention periods
Blood lipid profile (Fasted state)
Time frame: Baseline and post 14-day intervention periods
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 6 Nov 2024.
- Derived from this study: PubMed 42782361van Bruinessen M, Liu Z, Heuven LAJ, Stieger M, Lasschuijt MP, Forde CG. Satiety responsiveness following dietary exposure to ultra-processed foods differing in texture-derived eating rate: a secondary analysis of a randomized controlled crossover diet intervention. Eur J Nutr. 2026 Sep 24;65(7):261. doi: 10.1007/s00394-026-04111-7.
- Derived from this study: PubMed 41314613Forde CG, Heuven LA, van Bruinessen M, Liu Z, Stieger M, de Graaf K, Lasschuijt MP. Eating rate has sustained effects on energy intake from ultraprocessed diets: a 2-week ad libitum dietary randomized controlled crossover trial. Am J Clin Nutr. 2026 Apr;123(4):101122. doi: 10.1016/j.ajcnut.2025.11.012. Epub 2025 Nov 26.
- Derived from this study: PubMed 40926558Lasschuijt MP, Heuven LAJ, van Bruinessen M, Liu Z, Rubert J, Stieger M, de Graaf K, Forde CG. The Effect of Eating Rate of Ultra-Processed Foods on Dietary Intake, Eating Behaviour, Body Composition and Metabolic Responses-Rationale, Design and Outcomes of the Restructure Randomised Controlled Trial. Nutr Bull. 2025 Dec;50(4):640-655. doi: 10.1111/nbu.70027. Epub 2025 Sep 9.
- Project webpageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be made available according to the FAIR principles on Open Science Framework (OSF)
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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 ultra-processed slow eating rate diet and Ultra-processed fast eating rate diet in people with Eating Rate, 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 0 inclusion and 7 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 6 Nov 2024. 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 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06113146, which also lists 3 linked publications.
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 6 Nov 2024.