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

Sponsor
Wageningen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06113146
Collaborator
Next Food Collective (previously TKI agri-food program and TiFN, Top Institute Food and Nutrition) (Other)
39
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: ultra-processed slow eating rate diet
  • Other: Ultra-processed fast eating rate diet
N/A

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 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, Dutch adults between 25-50 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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).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 (Participant, Outcomes Assessor)
Masking Description:
A block randomization scheme will be generated using EyeQuestion software, equal numbers of subjects will be randomly allocated to each treatment order. The allocation sequence will be concealed until participants are enrolled and assigned to the intervention orders. Treatments will be given a 3 random-digit code. 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. Treatment codes will only be revealed after data analysis. 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.
Primary Purpose:
Other
Official Title:
Impact of the Eating Rate of Ultra-processed Foods on Dietary Intake Behavior and Metabolic Responses
Actual Study Start Date :
Oct 2, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: ultra-processed slow eating rate diet then the ultra-processed fast eating rate diet

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
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.

Other: Ultra-processed fast eating rate diet
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.

Experimental: ultra-processed fast eating rate diet then the ultra-processed slow eating rate diet

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
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.

Other: Ultra-processed fast eating rate diet
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.

Outcome Measures

Primary Outcome Measures

  1. Average daily energy intake (kcal/day) [Two periods of 14 days]

    The average (across two weeks) daily energy intake (kcal/day) in each diet arm

Secondary Outcome Measures

  1. Total Energy intake (kcal) [Two periods of 14 days]

    Ad libitum energy intake (kcal) per meal, day and week.

  2. Total Food intake (gram) [Two periods of 14 days]

    Ad libitum food intake (gram) per meal, day, week and average daily food intake (gram/day) in each diet arm.

  3. Cumulative energy intake (kcal) [Two periods of 14 days]

    Cumulative energy intake (kcal) over the study period (14 days)

  4. Cumulative food intake (gram) [Two periods of 14 days]

    Cumulative food intake (gram) over the study period (14 days)

  5. Body weight (kg) [Pre and post intervention periods and six times (every other day) during each intervention period of 14 days]

    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.

  6. Total and Regional Fat Mass and Fat Free Mass (kg, %) [Pre and post 14-day intervention periods]

    Changes in fat mass and fat free mass (kg, %) will be measured using; DEXA, air displacement plethysmography (BODPOD), skinfold measurements

  7. Postprandial hormone responses (Mixed Meal Tolerance Test) [Baseline and post 14-day intervention periods]

    Insulin and glucose, total ghrelin, total GLP-1, PP, PYY, Glucagon and c-peptide responses, to a fixed calorie test meal (rice porridge)

  8. Metabolic outcomes (Mixed Meal Tolerance Test) [Baseline and post 14-day intervention periods]

    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.

  9. Glucose Excursions [Every 15 minutes throughout two 14-day intervention periods]

    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.

  10. Leptin and Ghrelin levels (Fasted state) [Baseline and post 14-day intervention periods]

    Leptin, Ghrelin blood plasma concentrations after an overnight fast

  11. Blood lipid profile (Fasted state) [Baseline and post 14-day intervention periods]

    Total cholesterol, HDL, LDL, free fatty acids and other blood lipids

Other Outcome Measures

  1. Eating behaviour observed during meals of intervention diets using video-annotation [Two periods of 14 days]

    Total meal duration (min), bite duration (min) and number of bites

  2. Derived measures of eating behaviour observed during meals of intervention diets using video-annotation [Two periods of 14 days]

    Derived measures of eating behaviour such as eating rate (g/min) based on video-annotation.

  3. Micro-structure of eating observed during meals of intervention diets using video-annotation [Two periods of 14 days]

    Chewing behaviour, oro-sensory exposure time, bite size (gram/bite) and bite frequency (bite/min) based on video-annotation.

  4. Eating behaviour observed during meals of intervention diets using weighing tray [Two periods of 14 days]

    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.

  5. Sensory attributes of intervention meals [pre and post meals during two 14-day intervention periods]

    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).

  6. Macro-nutrient intake (grams and %EN) [Two periods of 14 days]

    Intake of carbohydrates, protein, and fat (gram; %EN) per meal, day, week and study period.

  7. Dietary intake during washout periods [At baseline and washout; 3 days]

    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).

  8. Sodium and nitrogen in urine (24 hr urine sample collection) [4 x 24 hours during the intervention periods and 4 times urine sample collection during the two 14 day intervention periods]

    Sodium and nitrogen in urine will be measured in urine as markers for salt and protein intake as compliance markers of participants dietary intakes

  9. Urine metabolites (24 hr urine sample collection) [3x24hr urine collection once at baseline and post both 14-day intervention periods]

    Untargeted metabolomics, C-peptide, creatinine

  10. Nutrient intake (grams and %en) during intervention periods [Two periods of 14 days]

    Intake of mono- and disaccharides, fibre (grams, gram/100 kcal) and salt (grams, gram/100kcal) per meal, day, week and study period

  11. Subjective appetite [pre and post meals during two 14-day intervention periods]

    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).

  12. Adiposity distribution [Pre and post 14-day intervention periods]

    Waist to hip ratio circumference will be calculated by dividing the waist measurement (cm) by the hip measurement (cm).

  13. Water retention [Pre and post 14-day intervention periods]

    Changes in water retention (kg, %) will be measured using bio impedance analysis (BIA)

  14. Glucose level (various outcomes) [Two periods of 14 days]

    24-hour glucose levels will be measured every 15 minutes using Continues Glucose Monitoring (CGM).

  15. HbA1c [Baseline; 10 minutes]

    Blood HbA1c

  16. Resting energy expenditure [Baseline and post 14-day intervention periods]

    VO2 and VCO2 measures will be measured using the ventilated hood for 30 minutes

  17. Person trait: oral processing behaviour [Screening; 5 minutes]

    Standardized method to determine oral processing behaviour as a personal trait (Carrot test).

  18. Appetitive Traits (study population characteristics): Dutch Eating Behaviour Questionnaire [Screening; 15 minutes]

    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.

  19. Appetitive Traits (study population characteristics): Adult Eating behaviour questionnaire [Screening; 15 minutes]

    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'.

  20. Appetitive Traits (study population characteristics): Reasons Individuals Stop Eating Questionnaire [Screening; 5 minutes]

    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.

  21. Person trait: Interoceptive awareness [Screening; 15 minutes]

    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'.

  22. Diet Satisfaction [Baseline and post 14-day intervention periods]

    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).

  23. Habitual dietary intake at baseline [At baseline covering past 14 days]

    Using the Food Frequency Questionnaire (FFQ) the dietary intake at baseline will be measured in terms of macro(nutrients) and NOVA class.

  24. Person trait: Salivary flow [Baseline; 15 minutes]

    Alpha-amylase activity and stimulated saliva flow rate

  25. Blood pressure (fasted state) [Baseline and post 14-day intervention periods]

    measured in mm/hg after an overnight fast

  26. Physical activity: accelerometry [Two periods of 14 days]

    Physical activity will be measured using accelerometry

  27. Physical activity: exercise diary [Two periods of 14 days]

    Physical activity will be measured using exercise diaries

  28. Physical activity questionnaire [Baseline; 10 minutes]

    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.

  29. Markers of gut health [Baseline and post 14-day intervention periods]

    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.

  30. Bolus properties (person characteristic) [Baseline and post 14-day intervention periods]

    The bolus properties the mixed meal tolerance test will be analysed on total number, surface area (mm2), and particle size (mm2 or mm).

  31. Bolus saliva uptake (person characteristic) [Baseline and post 14-day intervention periods]

    The bolus properties the mixed meal tolerance test will be analysed on the amount of saliva uptake (g).

  32. Microbiome [Pre and post 14-day intervention periods]

    Measuring of fecal metabolite profile (SCFAs, tryptophan metabolites and bile acids), metagenomics, microbiota composition, and water content of fecal samples

  33. Gut transit time [Pre and post 14-day intervention periods]

    Measure of gut transit time using the blue dye test

  34. Gastrointestinal symptoms [Baseline and post 14-day intervention periods]

    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.

  35. Stoolform [Baseline and half-way and post 14-day interventions periods]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

In order to be eligible to participate in this study, a participant must meet all of the following criteria:

  • Between 25-50 years old at the day of inclusion

  • Dutch nationality

  • 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

  • Having facial hair such as a beard as facial movements cannot be analysed

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wageningen University Wageningen Gelderland Netherlands 6708 WE

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Ciaran Forde, prof.dr. CG (Ciarán) Forde, Wageningen University
ClinicalTrials.gov Identifier:
NCT06113146
Other Study ID Numbers:
  • RESTRUCTURE- Revamp Study
First Posted:
Nov 2, 2023
Last Update Posted:
Nov 8, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ciaran Forde, prof.dr. CG (Ciarán) Forde, Wageningen University

Study Results

No Results Posted as of Nov 8, 2023