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| Name | Class |
|---|---|
| Next Food Collective (previously TKI agri-food program and TiFN, Top Institute Food and Nutrition) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultra-processed slow eating rate diet | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Average daily energy intake (kcal/day) | The average (across two weeks) daily energy intake (kcal/day) in each diet arm | Two periods of 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total Energy intake (kcal) | Ad libitum energy intake (kcal) per meal, day and week. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Eating behaviour observed during meals of intervention diets using video-annotation | Total meal duration (min), bite duration (min) and number of bites | Two periods of 14 days |
| Derived measures of eating behaviour observed during meals of intervention diets using video-annotation |
In order to be eligible to participate in this study, a participant must meet all of the following criteria:
A potential participant who meets any of the following criteria will be excluded from participation in this study:
Based on the information meeting:
Exclusion after screening:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wageningen University | Wageningen | Gelderland | 6708 WE | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41314613 | Derived | Forde 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. | |
| 40926558 |
| Label | URL |
|---|---|
| Project webpage | View source |
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Data will be made available according to the FAIR principles on Open Science Framework (OSF)
Prior to data analyses
Statistical Analysis Plan and the Analytic Code will be made available at OSF
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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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).
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To cover the true aim of the study, participants will be told that the study is about different types of protein and body composition changes and that this is not a weight-loss study. Participants will be debriefed about the true study aim by email when the last participant finishes the study.
Equal numbers of participants will be randomly allocated to each treatment order. The allocation sequence will be concealed until participants are enrolled and assigned to the intervention orders. Meals will be given a 3 random-digit code to conceal treatment allocation. However, the diets cannot be administered in a fully blinded manner due to the nature of the study foods. Study participants and research staff involved in food provision might be able to identify differences between the diets based on the types of foods served.
Data is blinded by an independent researcher outside of the research project and unblinding will occur after the primary analyses have been conducted.
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| Ultra-processed fast eating rate diet | Other | 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. |
|
| Two periods of 14 days |
| Cumulative energy intake (kcal) | Cumulative energy intake (kcal) over the study period (14 days) | Two periods of 14 days |
| Cumulative food intake (gram) | Cumulative food intake (gram) over the study period (14 days) | 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. | 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 | 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) | 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. | 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. | Every 15 minutes throughout two 14-day intervention periods |
| Leptin and Ghrelin levels (Fasted state) | Leptin, Ghrelin blood plasma concentrations after an overnight fast | Baseline and post 14-day intervention periods |
| Blood lipid profile (Fasted state) | Total cholesterol, HDL, LDL, free fatty acids and other blood lipids | Baseline and post 14-day intervention periods |
Derived measures of eating behaviour such as eating rate (g/min) based on video-annotation. |
| Two periods of 14 days |
| Micro-structure of eating observed during meals of intervention diets using video-annotation | Chewing behaviour, oro-sensory exposure time, bite size (gram/bite) and bite frequency (bite/min) based on video-annotation. | Two periods of 14 days |
| Eating behaviour observed during meals of intervention diets using weighing tray | Eating behaviour characteristics (eating rate (gram/min), total meal duration (min), bite duration (min), bite frequency (bite/min), number of bites (per meal), bite size (gram/bite), oro-sensory exposure time (seconds/bite), cumulative weight change of the meal from start to end, based on weighing tray. | Two periods of 14 days |
| Sensory attributes of intervention meals | Sensory properties, liking and familiarity of the meals, assessed after one bite of each meal on a 100mm Visual Analogue Scale ranging from "Not at all" (0mm) to "Extremely" (100mm). | pre and post meals during two 14-day intervention periods |
| Macro-nutrient intake (grams and %EN) | Intake of carbohydrates, protein, and fat (gram; %EN) per meal, day, week and study period. | Two periods of 14 days |
| Dietary intake during washout periods | Dietary intake (energy intake, macronutrients, fiber, salt, and UPF) will be measured using a 3 day food diary ( 2 week-days and one weekend day). | At baseline and washout; 3 days |
| Sodium and nitrogen in urine (24 hr urine sample collection) | Sodium and nitrogen in urine will be measured in urine as markers for salt and protein intake as compliance markers of participants dietary intakes | 4 x 24 hours during the intervention periods and 4 times urine sample collection during the two 14 day intervention periods |
| Urine metabolites (24 hr urine sample collection) | Untargeted metabolomics, C-peptide, creatinine | 3x24hr urine collection once at baseline and post both 14-day intervention periods |
| Nutrient intake (grams and %en) during intervention periods | Intake of mono- and disaccharides, fibre (grams, gram/100 kcal) and salt (grams, gram/100kcal) per meal, day, week and study period | Two periods of 14 days |
| Dutch Healthy Diet index 2015 | Dutch Healthy Diet index 2015 (DHD15-index) consists of fifteen components each representing one of the fifteen food-based Dutch dietary guidelines (2015). Per component the score ranges from 0 to 10, resulting in a final total range score between 0 (no adherence) and 150 (complete adherence). | At baseline, two periods of 14 days and washout |
| Subjective appetite | Summary of questions on participants' perceived level of hunger, fullness, thirst and the desire to eat indicated on 100mm Visual Analogue Scales ranging from "Not at all" (0mm) to "Extremely" (100mm). | pre and post meals during two 14-day intervention periods |
| Adiposity distribution | Waist to hip ratio circumference will be calculated by dividing the waist measurement (cm) by the hip measurement (cm). | Pre and post 14-day intervention periods |
| Water retention | Changes in water retention (kg, %) will be measured using bio impedance analysis (BIA) | Pre and post 14-day intervention periods |
| Glucose level (various outcomes) | 24-hour glucose levels will be measured every 15 minutes using Continues Glucose Monitoring (CGM). | Two periods of 14 days |
| HbA1c | Blood HbA1c | Baseline; 10 minutes |
| Resting energy expenditure | VO2 and VCO2 measures will be measured using the ventilated hood for 30 minutes | Baseline and post 14-day intervention periods |
| Person trait: oral processing behaviour | Standardized method to determine oral processing behaviour as a personal trait (Carrot test). | Screening; 5 minutes |
| Appetitive Traits (study population characteristics): Dutch Eating Behaviour Questionnaire | The Dutch Eating Behavior Questionnaire (DEBQ) consists out of 33 questions which can be scored from "Never" (1) to "Very often" (5) and will be used to classify participants based on their eating behavior trait (restrained eater, emotional eater, external eater). High restrained eaters will be identified with DEBQ restrained eater scale ≥ 2.90 for males and ≥ 3.40 for females. | Screening; 15 minutes |
| Appetitive Traits (study population characteristics): Adult Eating behaviour questionnaire | The Adult Eating Behaviour Questionnaire (AEBQ) will be used to characterize the appetitive traits of the participants. The questionnaire consists out of 35 statements which can be scored from "Strongly agree" (1) to "Strongly disagree" (5). The statements are summarized into the scales 'Enjoyment of food', 'Emotional over-eating', 'emotional under-eating', 'Food fussiness', 'Food responsiveness', 'Hunger', 'Slowness in eating', and 'Satiety responsiveness'. | Screening; 15 minutes |
| Appetitive Traits (study population characteristics): Reasons Individuals Stop Eating Questionnaire | The Reasons Individuals Stop Eating Questionnaire (RISE-Q15) consists out of 15 questions in which the reasons or eating cessation can be assessed. All items are scored on a 7-point frequency scale (Never, Rarely, Seldom, Sometimes, Often, Usually, and Always) and summarized into 5 subscales: decreased food appeal, physical satisfaction, planned amount, self-consciousness, and decreased priority of eating. | Screening; 5 minutes |
| Person trait: Interoceptive awareness | The conscious level of interception with its multiple dimensions potentially accessible to self-report will be accessed with the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2). MAIA-2 is a validated 8-scale state-trait questionnaire with 37 statements. The statements are scored from "Never" (0) to "Always" (5). The scales are 'Noticing', 'Not-Distracting', 'Not-Worrying', 'Attention regulation', 'Emotional Awareness', 'Self-Regulation', 'Body Listening', and 'Trusting'. | Screening; 15 minutes |
| Diet Satisfaction | The satisfaction of the participants with the diets (baseline, UPF fast and UPF slow) will be assessed with the Diet Satisfaction Questionnaire (Dsat-28) [40]. The Dsat-28 is a validated questionnaire that consists out of five scales accessed by 28 statements about the characteristics of the lifestyle and attitudes of individuals that reflect satisfaction within the diets. The agreement to the statements will be scored from "Disagree strongly" (1) to "Agree strongly" (5). The scales are 'Healthy Lifestyle', 'Eating Out', 'Costs', 'Preoccupation with Food', and 'Planning and preparation' . Only questions that are applicable will be asked (e.g. for the test diets no questions belonging to the scales Costs or Eating Out will be asked). | Baseline and post 14-day intervention periods |
| Habitual dietary intake at baseline | Using the Food Frequency Questionnaire (FFQ) the dietary intake at baseline will be measured in terms of macro(nutrients) and NOVA class. | At baseline covering past 14 days |
| Person trait: Salivary flow | Alpha-amylase activity and stimulated saliva flow rate | Baseline; 15 minutes |
| Blood pressure (fasted state) | measured in mm/hg after an overnight fast | Baseline and post 14-day intervention periods |
| Physical activity: accelerometry | Physical activity will be measured using accelerometry | Two periods of 14 days |
| Physical activity: exercise diary | Physical activity will be measured using exercise diaries | Two periods of 14 days |
| Physical activity questionnaire | The International Physical Activity Questionnaire-Short Form (IPAQ-SF) records the activity of the last 7 days on four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting. It estimates energy expenditure based on reported physical activity. | Baseline; 10 minutes |
| Markers of gut health | Inflammatory and leaky gut markers will be measured by measuring changes in C-reactive protein (CRP), IL-6, IL-8, TNF-α,levels of zonulin, gamma-glutamyltransferase, leukocytes, lipopolysaccharide-binding protein, soluble CD14, bactericidal increasing protein, peptidoglycan in fasted state. | Baseline and post 14-day intervention periods |
| Bolus properties (person characteristic) | The bolus properties the mixed meal tolerance test will be analysed on total number, surface area (mm2), and particle size (mm2 or mm). | Baseline and post 14-day intervention periods |
| Bolus saliva uptake (person characteristic) | The bolus properties the mixed meal tolerance test will be analysed on the amount of saliva uptake (g). | Baseline and post 14-day intervention periods |
| Microbiome | Measuring of fecal metabolite profile (SCFAs, tryptophan metabolites and bile acids), metagenomics, microbiota composition, and water content of fecal samples | Pre and post 14-day intervention periods |
| Gut transit time | Measure of gut transit time using the blue dye test | Pre and post 14-day intervention periods |
| Gastrointestinal symptoms | The Irritable bowel syndrome severity scoring system (IBS-SSS) will be used to assess the severity of IBS (gastrointestinal symptoms). The IBS-SSS consists of five questions in which severity of IBS symptoms in the last 10 days will be assessed on a 0 - 100 VAS scale. The sum of the scores of these five questions indicate the severity of IBS with a maximum achievable score of 500. Scores of 75 - 175 indicate a mild form of the disease, 175-300 a moderate form and scores of 175-300 indicate a severe type of IBS. | Baseline and post 14-day intervention periods |
| Stoolform | Participants will be asked classify their stool on the Bristol Stool Form Scale (BSFS). The BSFS is a 7-pont scale. The BSFS is an ordinal scale of stool types ranging from the hardest (Type 1) to the softest (Type 7). Types 1 and 2 are considered to be abnormally hard stools while Types 6 and 7 are considered abnormally loose/liquid stools. Type 3, 4 and 5 are therefore generally considered to be the most 'normal' stool form and are the modal stool forms in cross-sectional surveys of healthy adults. | Baseline and post 14-day interventions periods |
| Lasschuijt 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. |