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Speed Limits: Food Intake and Eating Behaviour of Ultra-processed and Unprocessed Foods (Vogue)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04280146
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Wageningen University

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.


Condition or disease Intervention/treatment Phase
Obesity; Excess Calories Behavioral: daily energy intake Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

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

Masking: Single (Participant)
Masking Description: Investigate cultural difference on eating behaviour
Primary Purpose: Treatment
Official Title: Speed Limits: Food Intake and Eating Behaviour of Ultra-processed and Unprocessed Foods
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : July 31, 2020

Arm Intervention/treatment
Active Comparator: Degree of food processing
unprocessed vs ultra-processed foods according to NOVA table.
Behavioral: daily energy intake
Investigate daily energy intake according to eating rate and food processing
Other Name: eating rate

Active Comparator: eating rate
slow vs fast eating rate (kcal/min), manipulated by food form
Behavioral: daily energy intake
Investigate daily energy intake according to eating rate and food processing
Other Name: eating rate




Primary Outcome Measures :
  1. Energy intake [ Time Frame: 1 day ]
    Daily energy intake



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 (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).

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 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
  • High restrained eater according to the Dutch Eating Behaviour Questionnaire (men: score>2.9)*. * This exclusion criterion will not explicitly be communicated to the participants to prevent desirable answers.
  • 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 (< -1) 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280146


Contacts
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Contact: Dieuwerke P Bolhuis, PhD 31 (0) 317 48 58 70 dieuwerke.bolhuis@wur.nl
Contact: Marlou Lasschuijt, MSc marlou.lasschuijt@wur.nl

Locations
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Netherlands
Wageningen University Recruiting
Wageningen, Netherlands, 6700
Contact: Marlou Lasschuijt, MSc       marlou.lasschuijt@wur.nl   
Sponsors and Collaborators
Wageningen University
Investigators
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Principal Investigator: Dieuwerke P Bolhuis, PhD Wageninge University

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Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT04280146    
Other Study ID Numbers: SEC 2020-11
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No