NCT04280146

Brief Summary

Rationale: Foods that can be eaten at a fast rate - with low mastication effort - lead to shorter orosensory exposure (OSE) per unit of food consumed. This results in a decreased satiation response and higher subsequent food intake. Recent research has shown that participants on a ultra-processed diet have an higher caloric intake and gain body weight compared to those on an unprocessed food diet. In this study the ultra-processed vs. unprocessed meals were classified according to the NOVA classification and matched on caloric content and palatability. The NOVA classification, classifies foods based on the physical, biological and chemical processes that occur after foods are separated from nature, and before they are consumed or used in the preparation of dishes and meals. However, it remains unclear whether the found increase in food intake of ultra-processed foods is due to industrial processing or because of a difference in eating rate at which the (ultra-)processed foods can be consumed. Objective: The objective of this study is to determine the independent and additive effects of industrial food processing (according to the NOVA classification) and eating rate on satiation. Study design: The study has a 2x2 randomized crossover design. All participants receive 4 treatments and are their own control. Study population: Healthy adults (n=60) between 18-55 years old with a BMI between 18.5-27 kg/m2. Intervention: Participants will join 4 test days during which they receive 3 main test meals (breakfast, lunch, dinner) and in-between meals snacks according to one of the 4 diets. The 4 diets of this study are: 1) unprocessed, slow eating rate 2) unprocessed, fast eating rate 3) ultra-processed, slow eating rate 4) ultra- processed, fast eating rate. 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 intake during the three main meals and during snack time. 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. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk associated with participation is small and the burden can be considered as moderate. The knowledge obtained may be used to develop products or strategies that enhance healthy choices and eating behaviour and consequently help prevent overweight and obesity. We consider the knowledge obtained and possible implications of this study to outweigh the individual burden.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

February 20, 2020

Last Update Submit

February 20, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Energy intake

    Daily energy intake

    1 day

Study Arms (2)

Degree of food processing

ACTIVE COMPARATOR

unprocessed vs ultra-processed foods according to NOVA table.

Behavioral: daily energy intake

eating rate

ACTIVE COMPARATOR

slow vs fast eating rate (kcal/min), manipulated by food form

Behavioral: daily energy intake

Interventions

Investigate daily energy intake according to eating rate and food processing

Also known as: eating rate
Degree of food processingeating rate

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 (after signing informed consent)
  • Good general health and appetite (F1 questionnaire self-report)
  • Commonly (5 out of 7 week days) eating three meals a day every day around approximately the same times. (This is a Self-report question; see F1 questionnaire).

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 or believes.
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, 6700, Netherlands

RECRUITING

Related Publications (1)

  • Lasschuijt M, Camps G, Mars M, Siebelink E, de Graaf K, Bolhuis D. Speed limits: the effects of industrial food processing and food texture on daily energy intake and eating behaviour in healthy adults. Eur J Nutr. 2023 Oct;62(7):2949-2962. doi: 10.1007/s00394-023-03202-z. Epub 2023 Jul 14.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dieuwerke P Bolhuis, PhD

    Wageninge University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dieuwerke P Bolhuis, PhD

CONTACT

Marlou Lasschuijt, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Investigate cultural difference on eating behaviour
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Subjects are exposed foods for four days. 1 day Ultra processed fast food 1 day Ultra processed slow foods 1 day unprocessed fast food 1 day unprocessed slow food
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 21, 2020

Study Start

February 1, 2020

Primary Completion

April 30, 2020

Study Completion

July 31, 2020

Last Updated

February 21, 2020

Record last verified: 2020-02

Locations