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Completed

NCT Number: NCT05659771

Opportunities for Food Reformulation

The objective of this study is to determine the independent and additive effects of food texture and energy density on food and energy intake compared to a control condition.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen university

Wageningen, Gelderland, 6708WE, Netherlands

About this study

Study design: The study has a 2x2 randomized crossover design. All participants receive 5 treatments and are their own control.

Study population: Healthy adults (n=75) between 18-55 years old with a BMI between 18.5-30 kg/m2.

Intervention: Participants will join 5 test days during which they receive, 5 test meals (lunch). The 5 test meals of this study are: 1.) low energy density, hard texture (slow eating rate) 2.) low energy density, soft texture (fast eating rate) 3.) High energy density, hard texture (slow eating rate) 4.) High energy density, soft texture (fast eating rate) 5.) Average energy density and medium hard texture (control). During eating and before and after eating the weight of the plate will be measured to determine intake. Additionally, participants will be recorded on video to determine eating behaviour (number of bites, chews and oral processing duration). The order in which participants will receive the diets will be randomized. The evening before and during each test day participants will keep a food and exercise diary.

Main study parameters/endpoints: The main study outcomes are food and energy intake of each lunch meal. Secondary outcomes are, eating behaviour characteristics measured by video (eating rate (g/min and bites/min), number of chews (chews/bite and chews/gram), bite size (gram/bite), oral processing duration (seconds), appetite (hunger, fullness, desire to eat, desire to eat sweet, desire to eat savoury, prospective consumption) and sensory characteristics (liking (taste + smell), desire to eat the meal, expected satiation, sweet, savoury, smoothness, chewiness, thickness) of the meals. Additional outcomes are individual differences in microstructure of eating, appetite responsiveness, eating Behavior phenotype, interoceptive sensitivity and anthropometry measures. During the trial new technology to capture food intake and eating behavior will be validated which is also an outcome of this trial.

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 English fluently or without difficulty (self-report)
  • BMI 18.5-30 kg/m2 - measured by the researchers at the end of information meeting
  • 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 (21)
  • 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 or snacks
  • 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 )
  • Signed up for participating in another research study
  • Employee of Human Nutrition department of Wageningen university
  • Thesis student or intern at the chair group of Sensory Science and Eating Behaviour Human Nutrition (WUR).
  • Intensive exercising more than 8 hours per week
  • Low score for liking the test foods on a nine point likert scale based on pictures of the food items.
  • Unfamiliar with the test foods (self-report).

Treatment and study plan

Food properties manipulation to alter eating behavior and food and energy intake

Behavioral

Food properties of commercially available food products

Primary outcomes

  1. Energy intake

    Time frame: One meal, up to 30 minutes

    Intake in Kcal

  2. Food intake

    Time frame: One meal, up to 30 minutes

    Intake in gram

Secondary outcomes

  1. Eating rate

    Time frame: One meal, up to 30 minutes

    Eating rate gram/min

  2. chews

    Time frame: One meal, up to 30 minutes

    number of chews per bite

  3. bite size

    Time frame: One meal, up to 30 minutes

    gram/bite

  4. Energy intake rate

    Time frame: One meal, up to 30 minutes

    kcal/min

  5. bites

    Time frame: One meal, up to 30 minutes

    number of bites per meal

  6. swallows

    Time frame: One meal, up to 30 minutes

    number of swallows per meal

  7. oral exposure time

    Time frame: One meal, up to 30 minutes

    duration of food in mouth in seconds

  8. Appetite

    Time frame: One meal, up to 30 minutes

    subjective ratings of appetite on a 100 mm line scale (visual analogue scale)

  9. Individual differences in fat free mass (FFM)

    Time frame: 5 minutes

    % FFM of total body weight

  10. individual eating rate

    Time frame: 1 minute

    eating rate (gram/min) of carrots of each participant (personal trait)

  11. Individual appetite responsiveness

    Time frame: 10 minutes

    interoceptive sensitivity the ratio between the amount drank till first satiation signal and complete fullness, according to the waterload test

  12. Sensory properties

    Time frame: 5 minutes

    rating on a 100mm line scale (visual analogue scale from 0 - not at all to 100 extremely) of the sensory properties of the sandwiches offered during the test sessions

Other outcomes

  1. technology to measure intake automatically

    Time frame: One meal, up to 30 minutes

    automated weighing scales

  2. technology to measure eating behavior

    Time frame: One meal, up to 30 minutes

    automated measures of eating behavior using video recordings

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • 4TU pride and prejudice project

Registry information

Official study title

Opportunities For Food Reformulation: Food Texture and Energy Density Effects on Eating Behaviour and Satiation

Acronym: OffR

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 21, 2022
Registry last updated
Dec 21, 2022

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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