Impact of the Eating Rate of Ultra-processed Foods on Dietary Intake Behavior and Metabolic Responses

NCT06113146 | Completed

• 1 other identifier: RESTRUCTURE- Revamp Study
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eating Rate

Keywords

Eating rate; Food texture; Eating behaviour; Ultra-Processed Foods; Metabolism

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Total Energy intake (kcal)

  Two periods of 14 days

• Total Food intake (gram)

  Two periods of 14 days

• Cumulative energy intake (kcal)

  Two periods of 14 days

• Cumulative food intake (gram)

  Two periods of 14 days

• Body weight (kg)

  Pre and post intervention periods and six times (every other day) during each intervention period of 14 days

Other Outcomes (36)

• Eating behaviour observed during meals of intervention diets using video-annotation

  Two periods of 14 days

• Derived measures of eating behaviour observed during meals of intervention diets using video-annotation

  Two periods of 14 days

• Micro-structure of eating observed during meals of intervention diets using video-annotation

  Two periods of 14 days

Study Arms (2)

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.

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.

Other: ultra-processed slow eating rate diet; Other: Ultra-processed fast eating rate diet

Interventions

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.

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 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.

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

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

In order to be eligible to participate in this study, a participant must meet all of the following criteria: * Between 21-50 years old at the day of inclusion * Being able to read and understand English * BMI 21-27 kg/m2 * Good general and mental health and appetite (self-report) * Commonly (5 out of 7 week days) eating three meals a day around approximately the same times (self-report). A potential participant who meets any of the following criteria will be excluded from participation in this study: Based on the information meeting: * Difficulties with swallowing, chewing and/or eating in general * Suffering from an endocrine or eating disorder, gastrointestinal illness or illness of the thyroid gland, cardio-vascular diseases, bowel diseases, respiratory disease, neurological diseases, or diabetes, anaemia, cancer, or psychiatric conditions such as clinical depression, burnout or anxiety or bipolar disorder. * Having a history of low blood pressure * Having taste or smell disorders (self-report) * Braces (not including a dental wire) or oral piercing * Followed an energy restricted diet during the last 2 months * Currently using or in the past 3 months (calculated from the first day of the study) used prebiotics supplements, probiotic supplements and/or antibiotics * Gained or lost 5 kg of body weight over the last half year * High restrained eater (DEBQ restrained eater scale ≥ 2.90 for males and ≥ 3.40 for females \[23\])\* * Use of medication, including but not limited to hormone therapy or medications that affect the immune system or any medication that influences study outcomes such as food intake, appetite in general or metabolic responses (self-report) * Consuming on average more than 21 (men) or 14 (women) glasses of alcohol per week * Pregnant or lactating women, or women who are planning on becoming pregnant within the study period. * Smoking (daily) * Not willing to stop using drugs during the study period (from inclusion till last test session) * Not willing to stop consuming alcohol during the intervention weeks * Exercising more than 4 hours per week (excluding biking and walking at a normal pace and distance) * Following a vegetarian or vegan diet * Allergies or intolerance to any ingredient of the test meals * Not willing to eat the test food because of eating habits or believes * Do not like \> 20% of the test foods or its ingredients based on descriptions of the meal (scoring items ≤ dislike on a nine point hedonic scale)\* * Majority \> 50% of dietary food intake (g) is derived from ultra-processed foods (based on a food frequency questionnaire (FFQ) based on normative data collected in pre-trial.\* The 50% cut-off is based on median intake of UPFs in Dutch cohort studies \[24\] \[25\] * Being unfamiliar with \> 25% of the test meals * Signed up for participating in another research study * Being an employee or thesis student of the Division of Human Nutrition and Health at Wageningen university * Radiological investigation during past 7 days where iodine or barium containing contrast fluids have been used (DEXA contra-indication) * Nuclear medical investigation involving isotopes during past 7 days (DEXA contra-indication) Exclusion after screening: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wageningen University: lead
• Next Food Collective (previously TKI agri-food program and TiFN, Top Institute Food and Nutrition): collaborator

Study Sites (1)

Wageningen University

Wageningen, Gelderland, 6708 WE, Netherlands

Location

Related Publications (2)

• 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. 2025 Nov 26:101122. doi: 10.1016/j.ajcnut.2025.11.012. Online ahead of print.

  PMID: 41314613 DERIVED

• 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.

  PMID: 40926558 DERIVED

Related Links

• Project webpage

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.dr. CG (Ciarán) Forde

Model Details: 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).

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 2, 2023
• Study Start: October 2, 2023
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Prior to data analyses
• Access Criteria: Statistical Analysis Plan and the Analytic Code will be made available at OSF

Locations

NL (1)