NCT05019872

Brief Summary

Rationale: The world-wide rising obesity rates are a major health problem. Therefore, people should moderate food intake. A lower eating rate will decrease the energy intake. The eating rate of foods can be modified by changing the texture without affecting their acceptability. Harder, chunkier, more viscous, and more voluminous foods will decrease the eating rate and thus energy intake. However, the impact of texture on oral processing has mostly been studied as a model or single food system, whereas a diet consists of many different food products often consumed in combination. Little has been researched on the effect of food texture on eating rate within the context of realistic meals. It is not known if the eating rate of a meal is determined by the eating rate component with the lowest eating rate or if there is an additive effect of the eating rates of all components of the meal. Objective: The aim of the ESPA study is to determine how the eating rate of a pasta meal can be changed by manipulating the hardness of the ingredients and to investigate if the eating rate of a meal is determined by the eating rate of the component with the lowest eating rate or if there is an additive effect of the eating rates of all components of the meal. Study design: The study is a randomized crossover trial. All participants receive all pasta samples. Study population: Healthy adults (n=50) between 18-55 years old with European nationality, and a BMI between 18.5-30 kg/m2. Intervention: Participants will attend three test sessions during lunch in which in total twelve pasta samples will be consumed. The pasta samples will consists of individual or combined pasta noodles, vegetables, and sauce differing in hardness. The order of the samples will be randomized. After the consumption of the test samples, the participants will rate their appetite and the sensory characteristics of the samples. During the test sessions, participants will be video recorded to determine their eating behavior. Main study parameters/endpoints: The main study outcome is the eating rate (g/min). Secondary outcomes are the oral processing characteristics assessed with the video recordings (meal duration \[min\], bite duration \[min\], number of bites, number of chews, average bite size \[g\], average amount of chews per bite, and oral sensory exposure time \[min\]) and sensory characteristics rated on a visual analogue scale (liking \[flavor, texture, and overall\], flavor intensity, sweetness, saltiness, sourness, hardness, and chewiness).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

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

July 19, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

September 14, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2021

Completed
Last Updated

December 13, 2021

Status Verified

December 1, 2021

Enrollment Period

3 months

First QC Date

July 19, 2021

Last Update Submit

December 10, 2021

Conditions

Keywords

Eating ratePastaOral ProcessingEating BehaviourTextureHardness

Outcome Measures

Primary Outcomes (1)

  • Eating rate (g/min)

    Amount of the sample divided by the consumption time of the sample, measured with video recording.

    1 sample, up to 30 minutes

Secondary Outcomes (15)

  • Meal duration (min)

    1 sample, up to 30 minutes

  • Bite duration (min)

    1 sample, up to 30 minutes

  • Number of bites

    1 sample, up to 30 minutes

  • Number of chews

    1 sample, up to 30 minutes

  • Average bite size (g)

    1 sample, up to 30 minutes

  • +10 more secondary outcomes

Study Arms (12)

Penne hard

ACTIVE COMPARATOR

20 g penne cooked for 7 minutes

Behavioral: (Components of) pasta meal

Penne soft

ACTIVE COMPARATOR

20 g penne cooked for 20 minutes

Behavioral: (Components of) pasta meal

Carrot hard

ACTIVE COMPARATOR

50 g diced carrot cooked for 2 minutes

Behavioral: (Components of) pasta meal

Carrot soft

ACTIVE COMPARATOR

50 g diced carrot cooked for 20 minutes

Behavioral: (Components of) pasta meal

Penne hard + sauce

ACTIVE COMPARATOR

20 g penne cooked for 7 minutes + 10 g tomato sauce

Behavioral: (Components of) pasta meal

Penne soft + sauce

ACTIVE COMPARATOR

20 g penne cooked for 20 minutes + 10 g tomato sauce

Behavioral: (Components of) pasta meal

Carrot hard + sauce

ACTIVE COMPARATOR

50 g diced carrot cooked for 2 minutes + 10 g tomato sauce

Behavioral: (Components of) pasta meal

Carrot soft + sauce

ACTIVE COMPARATOR

50 g diced carrot cooked for 20 minutes + 10 g tomato sauce

Behavioral: (Components of) pasta meal

Penne hard + carrot hard + sauce

ACTIVE COMPARATOR

20 g penne cooked for 7 minutes + 50 g diced carrot cooked for 2 minutes + 20 g tomato sauce

Behavioral: (Components of) pasta meal

Penne hard + carrot soft + sauce

ACTIVE COMPARATOR

20 g penne cooked for 7 minutes + 50 g diced carrot cooked for 20 minutes + 20 g tomato sauce

Behavioral: (Components of) pasta meal

Penne soft + carrot hard + sauce

ACTIVE COMPARATOR

20 g penne cooked for 20 minutes + 50 g diced carrot cooked for 2 minutes + 20 g tomato sauce

Behavioral: (Components of) pasta meal

Penne soft + carrot soft + sauce

ACTIVE COMPARATOR

20 g penne cooked for 20 minutes + 50 g diced carrot cooked for 20 minutes + 20 g tomato sauce

Behavioral: (Components of) pasta meal

Interventions

Samples will be provided one by one in cups labeled with an unique code.

Carrot hardCarrot hard + sauceCarrot softCarrot soft + saucePenne hardPenne hard + carrot hard + saucePenne hard + carrot soft + saucePenne hard + saucePenne softPenne soft + carrot hard + saucePenne soft + carrot soft + saucePenne soft + sauce

Eligibility Criteria

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

You may qualify if:

  • European nationality
  • Able to understand and speak English fluently or without difficulty (self-report)
  • BMI 18.5-30 kg/m2 (self-report)
  • Good general health and appetite (self-report)
  • Regular consumers of pasta with tomato sauce (commonly once or more per month)

You may not qualify if:

  • Pregnant or lactating women
  • Smoking
  • Braces (not including a dental wire) or oral piercing
  • 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)
  • Use of medication that may influence study outcomes (self-report)
  • Consuming on average more than 21 glasses of alcohol per week
  • Intensive exercising more than eight hours per week
  • Allergies or intolerance to any ingredient of the test meals
  • Don't like pasta with tomato sauce or its ingredients (\<five on a nine point Likert scale)
  • Men having facial hair such as a beard as facial movements cannot be analyzed
  • Signed up for participating in another research study
  • Employee of Human Nutrition department of Wageningen university
  • Employee, thesis student or intern at the chair group of Sensory Science and Eating Behaviour Human Nutrition or Food Quality and Design (WUR)

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 Officials

  • Lise AJ Heuven, MSc

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: All participants receive twelve pasta samples differing in the hardness of carrots and penne, and the addition of sauce
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2021

First Posted

August 25, 2021

Study Start

September 14, 2021

Primary Completion

December 9, 2021

Study Completion

December 9, 2021

Last Updated

December 13, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations