Opportunities for Food Reformulation

NCT ID: NCT05659771

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-22

Study Completion Date

2022-07-08

Brief Summary

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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

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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

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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)
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
cover story - different aim

Study Groups

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low energy density, hard texture

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

Food properties of commercially available food products

low energy density, soft texture

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

Food properties of commercially available food products

High energy density, hard texture

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

Food properties of commercially available food products

High energy density, soft texture

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

Food properties of commercially available food products

Average energy density and medium hard texture (control)

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

Food properties of commercially available food products

Interventions

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

Food properties of commercially available food products

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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4TU pride and prejudice project

UNKNOWN

Sponsor Role collaborator

Wageningen University

OTHER

Sponsor Role lead

Responsible Party

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Marlou Lasschuijt

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wageningen university

Wageningen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 40516651 (View on PubMed)

Other Identifiers

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offR WUR

Identifier Type: -

Identifier Source: org_study_id