Sustained Effect of Food Texture of Ultra-processed Foods on Energy Intake

Eating Behavior Clinical Trial

Official title:

Sustained Effect of Food Texture of Ultra-processed Foods on Energy Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05561426
• Other study ID #: PRESTRUCTURE
• Status: Completed
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: April 14, 2023

Study information

• Verified date: April 2023
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study the sustained effect of food texture differences (slow vs fast eating rate) of ultra-processed foods on energy intake and body composition changes will be investigated.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Eating Behavior

Intervention

Other:
• Ad libitum breakfast and dinner meals for 12 days
Ad libitum portions of breakfast and dinner meals served at the eating behaviour lab

Locations

Country	Name	City	State
Netherlands	Wageningen University, Human Nutrition Department	Wageningen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective hunger	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
Other	Subjective fullness	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
Other	Subjective desire to eat	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
Other	Subjective prospective consumption	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
Other	Liking	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
Other	Flavour intensity	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
Other	Sweetness	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
Other	Sourness	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
Other	Saltiness	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
Other	Hardness	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
Other	Firmness	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
Other	Thickness	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
Other	Chewiness	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
Other	Dryness	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
Other	Cohesiveness	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
Other	Elasticity	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
Other	Springiness	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
Other	Stickiness	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
Other	Familiarity	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
Other	Expected satiation	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
Other	Desire to eat the meal	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
Other	Reasons for eating cessation	Reasons for eating cessation assessed with the Reasons Individuals Stop Eating Questionnaire (RISE-Q)	Two periods of 12 days
Other	Eating rate (g/min)	Eating rate (g/min) measured with video recording and automated video analysis	Two periods of 12 days
Other	Number of chews (chews/gram and chewes/bite)	Number of chews measured with video recording and automated video analysis	Two periods of 12 days
Other	Number of bites	Number of bites measured with video recording and automated video analysis	Two periods of 12 days
Other	Bite size	Bite size (gram/bite) measured with video recording and automated video analysis	Two periods of 12 days
Other	Oral processing duration (minutes)	Oral processing duration (minutes) measured with video recording and automated video analysis	Two periods of 12 days
Other	Oro-sensory exposure time (s/g)	Oro-sensory exposure time (s/g) measured with video recording and automated video analysis	Two periods of 12 days
Other	Physical activity	Energy expenditure will be measured using ActiGraph activity monitors	Two periods of 12 days
Other	Energy expenditure	Physical activity will be measured using ActiGraph activity monitors	Two periods of 12 days
Other	Energy intake during wash-out period	Energy (kcal) measured with a food dairy during the wash-out period	Period of 16 days
Other	Macro-nutrient intake during wash-out period	Macro-nutrient intake (g) measured with a food dairy during the wash-out period	Period of 16 days
Other	Ultra-processed food intake during wash-out period	UPF intake (%) measured with a food dairy during the wash-out period	Period of 16 days
Other	Habitual energy intake	Energy (kcal) measured with a food frequency questionnaire	One hour
Other	Habitual macro-nutrient intake	Macro-nutrient (g) measured with a food frequency questionnaire	One hour
Other	Habitual ultra-processed food intake	UPF intake (%) measured with a food frequency questionnaire	One hour
Other	Habitual physical activity	Habitual physical activity (MET-min/week) measured using the short version of the International Physical Activity Questionnaire (IPAQ)	Ten minutes
Other	Habitual energy expenditure	Habitual energy expenditure (kcal/week) measured using the short version of the International Physical Activity Questionnaire (IPAQ)	Ten minutes
Other	Self-reported eating rate	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
Other	Restrained eating, emotional eating and external eating	The level of restrained, emotional, and external eating assessed with the Dutch Eating Behaviour Questionnaire (DEBQ) consisting out of 33 questions.	Thirty minutes
Other	Diet satisfaction	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
Other	Appetitive traits	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
Primary	Average daily energy intake (kcal/day)	Daily energy intake across 12 days for each diet	Two periods of 12 days
Secondary	Body weight (kg)	Body weight (kg) measured using in duplicate using a weighing scale	Two periods of 12 days
Secondary	Fat free mass measured with bioelectrical impedance analysis	Fat free mass measured with bioelectrical impedance analysis (kg and %)	Two periods of 12 days
Secondary	Fat free mass measured with skinfold measurements	Fat free mass measured with skinfold measurements (kg and %)	Two periods of 12 days
Secondary	Fat mass measured with bioelectrical impedance analysis	Fat mass measured wit bioelectrical impedance analysis (kg and %)	Two periods of 12 days
Secondary	Fat mass measured with skinfold measurements	Fat mass measured with skinfold measurements (kg and %)	Two periods of 12 days
Secondary	Waist and hip circumference (cm)	Waist and hip circumference will be measured in duplicate using measuring tape	Two periods of 12 days
Secondary	BMI	Obtained by body weight (kg; measured using a weighing scale) and height (cm; measured using a stadiometer)	Two periods of 12 days