NCT05561426

Brief Summary

In this study the sustained effect of food texture differences (slow vs fast eating rate) of ultra-processed foods on energy intake and body composition changes will be investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 13, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

September 20, 2022

Last Update Submit

April 17, 2023

Conditions

Eating Behavior

Keywords

Food textureUltra-processed foodsFood intakeEnergy intakeEating rate

Outcome Measures

Primary Outcomes (1)

  • Average daily energy intake (kcal/day)

    Daily energy intake across 12 days for each diet

    Two periods of 12 days

Secondary Outcomes (7)

  • Body weight (kg)

    Two periods of 12 days

  • Fat free mass measured with bioelectrical impedance analysis

    Two periods of 12 days

  • Fat free mass measured with skinfold measurements

    Two periods of 12 days

  • Fat mass measured with bioelectrical impedance analysis

    Two periods of 12 days

  • Fat mass measured with skinfold measurements

    Two periods of 12 days

  • +2 more secondary outcomes

Other Outcomes (42)

  • Subjective hunger

    Two periods of 12 days

  • Subjective fullness

    Two periods of 12 days

  • Subjective desire to eat

    Two periods of 12 days

  • +39 more other outcomes

Study Arms (2)

Fast UPF meals

EXPERIMENTAL

Meals consisting of UPF with textures that are consumed fast

Other: Ad libitum breakfast and dinner meals for 12 days

Slow UPF meals

EXPERIMENTAL

Meals consisting of UPF with textures that are consumed slow

Other: Ad libitum breakfast and dinner meals for 12 days

Interventions

Ad libitum breakfast and dinner meals for 12 daysOTHER

Ad libitum portions of breakfast and dinner meals served at the eating behaviour lab

Fast UPF mealsSlow UPF meals

Eligibility Criteria

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

You may qualify if:

  • Able to understand and speak Dutch and English fluently or without difficulty (self-report)
  • BMI 18.5-30 kg/m2 - measured by the researchers during the information meeting (after signing informed consent)
  • 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
  • Use of medication that may influence study outcomes (self-report)
  • Allergies or intolerance to any ingredient of the test meals
  • 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
  • Signed up for participating in another research study of the Nutrition and Health department (WUR)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University, Human Nutrition Department

Wageningen, Gelderland, 6708 WE, Netherlands

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof.dr. CG (Ciarán) Forde

Study Record Dates

First Submitted

September 20, 2022

First Posted

September 30, 2022

Study Start

February 13, 2023

Primary Completion

April 14, 2023

Study Completion

April 14, 2023

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)