Overweight and ObesityOffRNCT05659771
Opportunities for Food Reformulation
A study testing Food properties manipulation to alter eating behavior and food and energy intake in people with Overweight and Obesity, run by Wageningen University at 1 site in Netherlands.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Food properties manipulation to alter eating behavior and food and energy intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Apr 2022to 8 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 22Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opportunities For Food Reformulation: Food Texture and Energy Density Effects on Eating Behaviour and Satiation
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.
- Conditions
- Overweight and Obesity
- Being tested
- Food properties manipulation to alter eating behavior and food and energy intake
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food properties manipulation to alter eating behavior and food and energy intakeBehavioural
Food properties of commercially available food products
| Study group | Role | What they receive |
|---|---|---|
| low energy density, hard texture | Experimental | Sandwich with a hard texture (slow eating rate) and relatively low energy density (kcal/g) Receives: Behavioral: Food properties manipulation to alter eating behavior and food and energy intake |
| low energy density, soft texture | Experimental | Sandwich with a soft texture (fast eating rate) and relatively low energy density (kcal/g) Receives: Behavioral: Food properties manipulation to alter eating behavior and food and energy intake |
| High energy density, hard texture | Experimental | Sandwich with a hard texture (slow eating rate) and relatively high energy density (kcal/g) Receives: Behavioral: Food properties manipulation to alter eating behavior and food and energy intake |
| High energy density, soft texture | Experimental | Sandwich with a soft texture (fast eating rate) and relatively high energy density (kcal/g) Receives: Behavioral: Food properties manipulation to alter eating behavior and food and energy intake |
| Average energy density and medium hard texture (control) | Active comparator | Sandwich with a medium texture (medium eating rate) and medium energy density (kcal/g) Receives: Behavioral: Food properties manipulation to alter eating behavior and food and energy intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake
Intake in Kcal
Measured: One meal, up to 30 minutes
Food intake
Intake in gram
Measured: One meal, up to 30 minutes
Secondary outcomes (12)
Eating rate
Eating rate gram/min
Measured: One meal, up to 30 minutes
chews
number of chews per bite
Measured: One meal, up to 30 minutes
bite size
gram/bite
Measured: One meal, up to 30 minutes
Energy intake rate
kcal/min
Measured: One meal, up to 30 minutes
bites
number of bites per meal
Measured: One meal, up to 30 minutes
swallows
number of swallows per meal
Measured: One meal, up to 30 minutes
oral exposure time
duration of food in mouth in seconds
Measured: One meal, up to 30 minutes
Appetite
subjective ratings of appetite on a 100 mm line scale (visual analogue scale)
Measured: One meal, up to 30 minutes
Individual differences in fat free mass (FFM)
% FFM of total body weight
Measured: 5 minutes
individual eating rate
eating rate (gram/min) of carrots of each participant (personal trait)
Measured: 1 minute
Individual appetite responsiveness
interoceptive sensitivity the ratio between the amount drank till first satiation signal and complete fullness, according to the waterload test
Measured: 10 minutes
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
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start22 Apr 2022
- Primary completion8 Jul 2022
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The 5 conditions 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)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- 4TU pride and prejudice project
- Responsible party
- Principal investigator, Marlou Lasschuijt, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659771
- Sponsor's protocol ID
- offR WUR
- Acronym
- OffR
- Status last verified
- Dec 2022
- First submitted
- 2 May 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lasschuijt MP, Heuven LA, Gonzalez-Estanol K, Siebelink E, Chen Y, Forde CG. The Effect of Energy Density and Eating Rate on Ad Libitum Energy Intake in Healthy Adults-A Randomized Controlled Study. J Nutr. 2025 Aug;155(8):2602-2610. doi: 10.1016/j.tjnut.2025.06.006. Epub 2025 Jun 12.
PubMed 40516651
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opportunities For Food Reformulation: Food Texture and Energy Density Effects on Eating Behaviour and Satiation
- ClinicalTrials.gov ID
- NCT05659771
- Acronym / sponsor ID
- OffR / offR WUR
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- 4TU pride and prejudice project
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- The 5 conditions 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)
| Arm | Type | Receives |
|---|---|---|
| low energy density, hard texture | Experimental | Behavioral: Food properties manipulation to alter eating behavior and food and energy intakeSandwich with a hard texture (slow eating rate) and relatively low energy density (kcal/g) |
| low energy density, soft texture | Experimental | Behavioral: Food properties manipulation to alter eating behavior and food and energy intakeSandwich with a soft texture (fast eating rate) and relatively low energy density (kcal/g) |
| High energy density, hard texture | Experimental | Behavioral: Food properties manipulation to alter eating behavior and food and energy intakeSandwich with a hard texture (slow eating rate) and relatively high energy density (kcal/g) |
| High energy density, soft texture | Experimental | Behavioral: Food properties manipulation to alter eating behavior and food and energy intakeSandwich with a soft texture (fast eating rate) and relatively high energy density (kcal/g) |
| Average energy density and medium hard texture (control) | Active comparator | Behavioral: Food properties manipulation to alter eating behavior and food and energy intakeSandwich with a medium texture (medium eating rate) and medium energy density (kcal/g) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food properties manipulation to alter eating behavior and food and energy intakeFood properties of commercially available food products | Behavioural | Average energy density and medium hard texture (control), High energy density, hard texture, High energy density, soft texture, low energy density, hard texture, low energy density, soft texture |
Primary outcome
Energy intake
Time frame: One meal, up to 30 minutes
Intake in Kcal
Food intake
Time frame: One meal, up to 30 minutes
Intake in gram
12 secondary outcomes
Eating rate
Time frame: One meal, up to 30 minutes
chews
Time frame: One meal, up to 30 minutes
bite size
Time frame: One meal, up to 30 minutes
Energy intake rate
Time frame: One meal, up to 30 minutes
bites
Time frame: One meal, up to 30 minutes
swallows
Time frame: One meal, up to 30 minutes
oral exposure time
Time frame: One meal, up to 30 minutes
Appetite
Time frame: One meal, up to 30 minutes
Individual differences in fat free mass (FFM)
Time frame: 5 minutes
individual eating rate
Time frame: 1 minute
Individual appetite responsiveness
Time frame: 10 minutes
Sensory properties
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Derived from this study: PubMed 40516651Lasschuijt MP, Heuven LA, Gonzalez-Estanol K, Siebelink E, Chen Y, Forde CG. The Effect of Energy Density and Eating Rate on Ad Libitum Energy Intake in Healthy Adults-A Randomized Controlled Study. J Nutr. 2025 Aug;155(8):2602-2610. doi: 10.1016/j.tjnut.2025.06.006. Epub 2025 Jun 12.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food properties manipulation to alter eating behavior and food and energy intake in people with Overweight and Obesity, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy intake (time frame: One meal, up to 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05659771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.