NCT05659771

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 2, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

3 months

First QC Date

May 2, 2022

Last Update Submit

December 12, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Energy intake

    Intake in Kcal

    One meal, up to 30 minutes

  • Food intake

    Intake in gram

    One meal, up to 30 minutes

Secondary Outcomes (12)

  • Eating rate

    One meal, up to 30 minutes

  • chews

    One meal, up to 30 minutes

  • bite size

    One meal, up to 30 minutes

  • Energy intake rate

    One meal, up to 30 minutes

  • bites

    One meal, up to 30 minutes

  • +7 more secondary outcomes

Other Outcomes (2)

  • technology to measure intake automatically

    One meal, up to 30 minutes

  • technology to measure eating behavior

    One meal, up to 30 minutes

Study Arms (5)

low energy density, hard texture

EXPERIMENTAL

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

low energy density, soft texture

EXPERIMENTAL

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

High energy density, hard texture

EXPERIMENTAL

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

High energy density, soft texture

EXPERIMENTAL

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

Average energy density and medium hard texture (control)

ACTIVE COMPARATOR

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

Food properties of commercially available food products

Average energy density and medium hard texture (control)High energy density, hard textureHigh energy density, soft texturelow energy density, hard texturelow energy density, soft texture

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)
  • 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 )
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen university

Wageningen, Gelderland, 6708WE, Netherlands

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

OverweightObesity

Interventions

FoodEnergy Intake

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDietNutritional Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
cover story - different aim
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 2, 2022

First Posted

December 21, 2022

Study Start

April 22, 2022

Primary Completion

July 8, 2022

Study Completion

July 8, 2022

Last Updated

December 21, 2022

Record last verified: 2022-12

Locations