CClinicalTrials.gg
CompletedNCT05659771OffRUpdated Dec 21, 2022

Opportunities for Food Reformulation

An interventional study of Food properties manipulation to alter eating behavior and food and energy intake in Overweight and Obesity, sponsored by Wageningen University. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-21.

Sponsored by Wageningen University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Overweight and Obesity

Browse trials for

03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 75 is close to the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Wageningen University is the lead sponsor of 150 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    low energy density, hard texture

    Sandwich with a hard texture (slow eating rate) and relatively low energy density (kcal/g)

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

  • Experimental
    low energy density, soft texture

    Sandwich with a soft texture (fast eating rate) and relatively low energy density (kcal/g)

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

  • Experimental
    High energy density, hard texture

    Sandwich with a hard texture (slow eating rate) and relatively high energy density (kcal/g)

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

  • Experimental
    High energy density, soft texture

    Sandwich with a soft texture (fast eating rate) and relatively high energy density (kcal/g)

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

  • Active comparator
    Average energy density and medium hard texture (control)

    Sandwich with a medium texture (medium eating rate) and medium energy density (kcal/g)

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

Interventions

  • BehavioralFood properties manipulation to alter eating behavior and food and energy intake

    Food properties of commercially available food products

06

What researchers measure

Primary outcomes

  1. Energy intake

    Intake in Kcal

    Time frame: One meal, up to 30 minutes

  2. Food intake

    Intake in gram

    Time frame: One meal, up to 30 minutes

Secondary outcomes

  1. Eating rate

    Eating rate gram/min

    Time frame: One meal, up to 30 minutes

  2. chews

    number of chews per bite

    Time frame: One meal, up to 30 minutes

  3. bite size

    gram/bite

    Time frame: One meal, up to 30 minutes

  4. Energy intake rate

    kcal/min

    Time frame: One meal, up to 30 minutes

  5. bites

    number of bites per meal

    Time frame: One meal, up to 30 minutes

  6. swallows

    number of swallows per meal

    Time frame: One meal, up to 30 minutes

  7. oral exposure time

    duration of food in mouth in seconds

    Time frame: One meal, up to 30 minutes

  8. Appetite

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

    Time frame: One meal, up to 30 minutes

  9. Individual differences in fat free mass (FFM)

    % FFM of total body weight

    Time frame: 5 minutes

  10. individual eating rate

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

    Time frame: 1 minute

  11. Individual appetite responsiveness

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

    Time frame: 10 minutes

  12. Sensory properties

    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

    Time frame: 5 minutes

Other outcomes

  1. technology to measure intake automatically

    automated weighing scales

    Time frame: One meal, up to 30 minutes

  2. technology to measure eating behavior

    automated measures of eating behavior using video recordings

    Time frame: One meal, up to 30 minutes

07

Study locations

1 site
  • Wageningen university
    Wageningen, Gelderland 6708WE, Netherlands
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05659771
Lead sponsor
Wageningen University
Collaborators
4TU pride and prejudice project
Responsible party
Marlou Lasschuijt (Assistant Professor, Wageningen University) — Principal investigator
First posted
Dec 21, 2022
Start date
Apr 22, 2022
Primary completion
Jul 8, 2022
Completion
Jul 8, 2022
Last update
Dec 21, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion