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Completed

NCT Number: NCT05561426

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

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.

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Key information

Conditions

Eating Behavior Behavior Behavior, Animal Feeding Behavior

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University, Human Nutrition Department

Wageningen, Gelderland, 6708 WE, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ad libitum breakfast and dinner meals for 12 days

Other

Ad libitum portions of breakfast and dinner meals served at the eating behaviour lab

Primary outcomes

  1. Average daily energy intake (kcal/day)

    Time frame: Two periods of 12 days

    Daily energy intake across 12 days for each diet

Secondary outcomes

  1. Body weight (kg)

    Time frame: Two periods of 12 days

    Body weight (kg) measured using in duplicate using a weighing scale

  2. 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 %)

  3. Fat free mass measured with skinfold measurements

    Time frame: Two periods of 12 days

    Fat free mass measured with skinfold measurements (kg and %)

  4. Fat mass measured with bioelectrical impedance analysis

    Time frame: Two periods of 12 days

    Fat mass measured wit bioelectrical impedance analysis (kg and %)

  5. Fat mass measured with skinfold measurements

    Time frame: Two periods of 12 days

    Fat mass measured with skinfold measurements (kg and %)

  6. Waist and hip circumference (cm)

    Time frame: Two periods of 12 days

    Waist and hip circumference will be measured in duplicate using measuring tape

  7. 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)

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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)

  23. Eating rate (g/min)

    Time frame: Two periods of 12 days

    Eating rate (g/min) measured with video recording and automated video analysis

  24. 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

  25. Number of bites

    Time frame: Two periods of 12 days

    Number of bites measured with video recording and automated video analysis

  26. Bite size

    Time frame: Two periods of 12 days

    Bite size (gram/bite) measured with video recording and automated video analysis

  27. Oral processing duration (minutes)

    Time frame: Two periods of 12 days

    Oral processing duration (minutes) measured with video recording and automated video analysis

  28. 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

  29. Physical activity

    Time frame: Two periods of 12 days

    Energy expenditure will be measured using ActiGraph activity monitors

  30. Energy expenditure

    Time frame: Two periods of 12 days

    Physical activity will be measured using ActiGraph activity monitors

  31. Energy intake during wash-out period

    Time frame: Period of 16 days

    Energy (kcal) measured with a food dairy during the wash-out period

  32. 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

  33. 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

  34. Habitual energy intake

    Time frame: One hour

    Energy (kcal) measured with a food frequency questionnaire

  35. Habitual macro-nutrient intake

    Time frame: One hour

    Macro-nutrient (g) measured with a food frequency questionnaire

  36. Habitual ultra-processed food intake

    Time frame: One hour

    UPF intake (%) measured with a food frequency questionnaire

  37. 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)

  38. Habitual energy expenditure

    Time frame: Ten minutes

    Habitual energy expenditure (kcal/week) measured using the short version of the International Physical Activity Questionnaire (IPAQ)

  39. 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')

  40. 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.

  41. 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

  42. 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'.

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 30, 2022
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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