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

Study Overview
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Brief Summary
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The aim of this balanced-order individually 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
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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 that can be consumed quickly lead to higher food intakes relative to slow consumed food, and this has been suggested as one of the ways in which (ultra-)processed foods promote excess in calorie intakes. We will therefore test the hypothesis that eating rate moderates energy intakes from ultra-processed foods. Objective: The primary objective of this study 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 (kcal) 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 eating rate. Study design: We will conduct a balanced-order, individually randomized controlled cross-over trial with 2 treatment arms, 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 (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 eating rate diet, and 2) a 14-days ultra-processed, fast eating rate diet. The ad libitum meal menu's will be matched for energy density (kcal/g), liking (hedonic range), macronutrients and level of processing, but different in textural characteristics known to influence eating rate. During the treatment periods participants will eat all of their main meals at the research site on weekdays. Participants will receive pre-packed meals to consume at home for the weekends. Meals will be served ad-libitum, presented in portions that are > 200% of a regular portion size. On both diet arms, participants will be asked to eat from each meal until they feel comfortably full, food and energy 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.

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

Conditions
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Eating Rate

Intervention / Treatment
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* Other: ultra-processed slow eating rate diet
* Other: Ultra-processed fast eating rate diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study is a balanced-order, individually 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ultra-processed slow eating rate diet then the ultra-processed fast eating rate diet<br>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<br>* 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.<br>Other: Ultra-processed fast eating rate diet<br>* 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.<br>|
| Experimental: ultra-processed fast eating rate diet then the ultra-processed slow eating rate diet<br>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<br>* 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.<br>Other: Ultra-processed fast eating rate diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eating rate, Food texture, Eating behaviour, Ultra-Processed Foods, Metabolism