- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05561426
Sustained Effect of Food Texture of Ultra-processed Foods on Energy Intake
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rationale: Several observational studies have shown that the consumption of ultra-processed foods (UPF) is associated with higher energy intake and obesity rates. However, the high eating rate of UPF might cause its high energy intake instead of the industrial processing level itself. There is a positive relationship between the eating rate and oro-sensory exposure of foods and subsequent energy intake. Food texture modifies eating rate and through that the energy intake of foods. It is shown that harder, chunkier, more viscous, and more voluminous foods decrease eating rate of foods and thus decrease energy intake. So far, research on food texture and energy intake has only been performed for one meal or one day and it is unknown if food texture and eating rate have a sustained effect on energy intake. Knowledge on the sustained effect of food texture differences could be used for strategies to drive or limit energy intake.
Objective: The primary objective is to determine the sustained effect of food texture differences (slow vs fast eating rate) of UPF on energy intake. The secondary objective is to determine the effect of texture differences (slow vs fast eating rate) of UPF on body composition changes.
Study design: The study has a randomized crossover design with two treatment arms. All participants receive both conditions (1. slow test breakfast and dinners consisting of UPF and 2. fast test breakfast and dinners consisting of UPF for twelve subsequent days) and are their own control (within subject effects).
Study population: Healthy Dutch speaking adults (n=20) between 18-55 years old with a BMI between 18.5-30 kg/m2.
Intervention: Participants will join two test periods, each consisting out of twelve days. During the test periods they will visit the eating behaviour lab where they receive ad libitum breakfast and dinner meals. During meal consumption participants are video recorded to determine eating behaviour. Standardized fixed portion lunch meals and snacks will be provided on-the-go. On weekend days participants will receive pre-packed meals. In one test period participants will receive meals consisting of UPF that have a hard texture (slow eating rate) and in the other period (randomized order) they will receive meals consisting of UPF with a soft texture (fast eating rate). The order in which participants will receive the meals within each condition will be (block) randomized.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gelderland
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Wageningen, Gelderland, Netherlands, 6708 WE
- Wageningen University, Human Nutrition Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between 18-55 years old at the day of inclusion
- Able to understand and speak Dutch and English fluently or without difficulty (self-report)
- BMI 18.5-30 kg/m2 - measured by the researchers during the information meeting (after signing informed consent)
- Good general health and appetite (self-report)
- Commonly (5 out of 7 week days) eating three meals a day every day around approximately the same times (self-report)
Exclusion Criteria:
- Difficulties with swallowing, chewing, and/or eating in general
- Suffering from an endocrine or eating disorder, gastrointestinal illness or illness of the thyroid gland, respiratory disease, or diabetes
- Having taste or smell disorders (self-report)
- Braces (not including a dental wire) or oral piercing
- Smoking
- Consuming on average more than 21 glasses of alcohol per week
- Not willing to stop using drugs during the study period (from inclusion till last test session)
- Use of medication that may influence study outcomes (self-report)
- Allergies or intolerance to any ingredient of the test meals
- Not willing to eat the test food because of eating habits, believes, or religion
- Following a vegetarian or vegan diet
- Lactose intolerant
- Men having facial hair such as a beard as facial movements cannot be analysed
- Followed an energy restricted diet during the last 2 months
- Gained or lost 5 kg of body weight over the last half year
- High restrained eater according to the Dutch Eating Behaviour Questionnaire (men: score>2.89, women>3.39) - this exclusion criterion will not explicitly be communicated to the participants to prevent desirable answers
- Signed up for participating in another research study of the Nutrition and Health department (WUR)
- Employee, thesis student or intern at the chair group of Sensory Science and Eating Behaviour Human Nutrition (WUR).
- Intensive exercising more than 5 hours per week
- Low score (<1) for liking the individual test meals on a nine point Likert scale based on pictures of the meals
- Unfamiliar with the test meals (self-report)
- Having an abnormal (non-representative) eating rates - measured by the researchers during the information meeting (after signing informed consent)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fast UPF meals
Meals consisting of UPF with textures that are consumed fast
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Ad libitum portions of breakfast and dinner meals served at the eating behaviour lab
|
|
Experimental: Slow UPF meals
Meals consisting of UPF with textures that are consumed slow
|
Ad libitum portions of breakfast and dinner meals served at the eating behaviour lab
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average daily energy intake (kcal/day)
Time Frame: Two periods of 12 days
|
Daily energy intake across 12 days for each diet
|
Two periods of 12 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body weight (kg)
Time Frame: Two periods of 12 days
|
Body weight (kg) measured using in duplicate using a weighing scale
|
Two periods of 12 days
|
|
Fat free mass measured with bioelectrical impedance analysis
Time Frame: Two periods of 12 days
|
Fat free mass measured with bioelectrical impedance analysis (kg and %)
|
Two periods of 12 days
|
|
Fat free mass measured with skinfold measurements
Time Frame: Two periods of 12 days
|
Fat free mass measured with skinfold measurements (kg and %)
|
Two periods of 12 days
|
|
Fat mass measured with bioelectrical impedance analysis
Time Frame: Two periods of 12 days
|
Fat mass measured wit bioelectrical impedance analysis (kg and %)
|
Two periods of 12 days
|
|
Fat mass measured with skinfold measurements
Time Frame: Two periods of 12 days
|
Fat mass measured with skinfold measurements (kg and %)
|
Two periods of 12 days
|
|
Waist and hip circumference (cm)
Time Frame: Two periods of 12 days
|
Waist and hip circumference will be measured in duplicate using measuring tape
|
Two periods of 12 days
|
|
BMI
Time Frame: Two periods of 12 days
|
Obtained by body weight (kg; measured using a weighing scale) and height (cm; measured using a stadiometer)
|
Two periods of 12 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective hunger
Time Frame: Two periods of 12 days
|
Hunger measured before and 0, 30, 60 and 90 minutes after meal consumption on a 100-mm VAS ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Subjective fullness
Time Frame: Two periods of 12 days
|
Fullness measured before and 0, 30, 60 and 90 minutes after meal consumption on a 100-mm VAS ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Subjective desire to eat
Time Frame: Two periods of 12 days
|
Desire to eat measured before and 0, 30, 60 and 90 minutes after meal consumption on a 100-mm VAS ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Subjective prospective consumption
Time Frame: Two periods of 12 days
|
Prospective consumption measured before and 0, 30, 60 and 90 minutes after meal consumption on a 100-mm VAS ranging from 'not at all' (0) to 'extremely' (100) with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Liking
Time Frame: Two periods of 12 days
|
Liking of meals after one bite and after meal consumption will be rated on a 100-mm VAS scale ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Flavour intensity
Time Frame: Two periods of 12 days
|
Flavour intensity after one bite will be rated on a 100-mm VAS scale ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Sweetness
Time Frame: Two periods of 12 days
|
Sweetness intensity after one bite will be rated on a 100-mm VAS scale ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Sourness
Time Frame: Two periods of 12 days
|
Sourness intensity after one bite will be rated on a 100-mm VAS scale ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Saltiness
Time Frame: Two periods of 12 days
|
Saltiness intensity after one bite will be rated on a 100-mm VAS scale ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Hardness
Time Frame: Two periods of 12 days
|
Hardness after one bite will be rated on a 100-mm VAS scale ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Firmness
Time Frame: Two periods of 12 days
|
Firmness after one bite will be rated on a 100-mm VAS scale ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Thickness
Time Frame: Two periods of 12 days
|
Thickness after one bite will be rated on a 100-mm VAS scale ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Chewiness
Time Frame: Two periods of 12 days
|
Chewiness after one bite will be rated on a 100-mm VAS scale ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Dryness
Time Frame: Two periods of 12 days
|
Dryness after one bite will be rated on a 100-mm VAS scale ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Cohesiveness
Time Frame: Two periods of 12 days
|
Cohesiveness after one bite will be rated on a 100-mm VAS scale ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Elasticity
Time Frame: Two periods of 12 days
|
Elasticity after one bite will be rated on a 100-mm VAS scale ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Springiness
Time Frame: Two periods of 12 days
|
Springiness after one bite will be rated on a 100-mm VAS scale ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Stickiness
Time Frame: Two periods of 12 days
|
Stickiness after one bite will be rated on a 100-mm VAS scale ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Familiarity
Time Frame: Two periods of 12 days
|
Familiarity (after one bite and after the meal) will be rated on a 100-mm VAS scale ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Expected satiation
Time Frame: Two periods of 12 days
|
Expected satiation (after one bite) will be rated on a 100-mm VAS scale ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Desire to eat the meal
Time Frame: Two periods of 12 days
|
Desire to eat the meal (after one bite and after the meal) will be rated on a 100-mm VAS scale ranging from 'not at all' to 'extremely' with anchors at the beginning and end of the line
|
Two periods of 12 days
|
|
Reasons for eating cessation
Time Frame: Two periods of 12 days
|
Reasons for eating cessation assessed with the Reasons Individuals Stop Eating Questionnaire (RISE-Q)
|
Two periods of 12 days
|
|
Eating rate (g/min)
Time Frame: Two periods of 12 days
|
Eating rate (g/min) measured with video recording and automated video analysis
|
Two periods of 12 days
|
|
Number of chews (chews/gram and chewes/bite)
Time Frame: Two periods of 12 days
|
Number of chews measured with video recording and automated video analysis
|
Two periods of 12 days
|
|
Number of bites
Time Frame: Two periods of 12 days
|
Number of bites measured with video recording and automated video analysis
|
Two periods of 12 days
|
|
Bite size
Time Frame: Two periods of 12 days
|
Bite size (gram/bite) measured with video recording and automated video analysis
|
Two periods of 12 days
|
|
Oral processing duration (minutes)
Time Frame: Two periods of 12 days
|
Oral processing duration (minutes) measured with video recording and automated video analysis
|
Two periods of 12 days
|
|
Oro-sensory exposure time (s/g)
Time Frame: Two periods of 12 days
|
Oro-sensory exposure time (s/g) measured with video recording and automated video analysis
|
Two periods of 12 days
|
|
Physical activity
Time Frame: Two periods of 12 days
|
Energy expenditure will be measured using ActiGraph activity monitors
|
Two periods of 12 days
|
|
Energy expenditure
Time Frame: Two periods of 12 days
|
Physical activity will be measured using ActiGraph activity monitors
|
Two periods of 12 days
|
|
Energy intake during wash-out period
Time Frame: Period of 16 days
|
Energy (kcal) measured with a food dairy during the wash-out period
|
Period of 16 days
|
|
Macro-nutrient intake during wash-out period
Time Frame: Period of 16 days
|
Macro-nutrient intake (g) measured with a food dairy during the wash-out period
|
Period of 16 days
|
|
Ultra-processed food intake during wash-out period
Time Frame: Period of 16 days
|
UPF intake (%) measured with a food dairy during the wash-out period
|
Period of 16 days
|
|
Habitual energy intake
Time Frame: One hour
|
Energy (kcal) measured with a food frequency questionnaire
|
One hour
|
|
Habitual macro-nutrient intake
Time Frame: One hour
|
Macro-nutrient (g) measured with a food frequency questionnaire
|
One hour
|
|
Habitual ultra-processed food intake
Time Frame: One hour
|
UPF intake (%) measured with a food frequency questionnaire
|
One hour
|
|
Habitual physical activity
Time Frame: Ten minutes
|
Habitual physical activity (MET-min/week) measured using the short version of the International Physical Activity Questionnaire (IPAQ)
|
Ten minutes
|
|
Habitual energy expenditure
Time Frame: Ten minutes
|
Habitual energy expenditure (kcal/week) measured using the short version of the International Physical Activity Questionnaire (IPAQ)
|
Ten minutes
|
|
Self-reported eating rate
Time Frame: One minute
|
Self-reported eating rate measured using the question "How would you describe your eating rate compared with others?" which can be answered on a five-point Likert scale ('very slow', 'slow', 'average', 'fast' or 'very fast')
|
One minute
|
|
Restrained eating, emotional eating and external eating
Time Frame: Thirty minutes
|
The level of restrained, emotional, and external eating assessed with the Dutch Eating Behaviour Questionnaire (DEBQ) consisting out of 33 questions.
|
Thirty minutes
|
|
Diet satisfaction
Time Frame: Ten minutes
|
The Diet Satisfaction Questionnaire (DSat-28) 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
|
Ten minutes
|
|
Appetitive traits
Time Frame: Ten minutes
|
The Adult Eating Behaviour Questionnaire (AEBQ) will be used to characterize the appetitive traits of the participants (Hunot et al., 2016).
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'.
|
Ten minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PRESTRUCTURE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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