Status:
COMPLETED
Impact of the Eating Rate of Ultra-processed Foods on Dietary Intake Behavior and Metabolic Responses
Lead Sponsor:
Wageningen University
Collaborating Sponsors:
Next Food Collective (previously TKI agri-food program and TiFN, Top Institute Food and Nutrition)
Conditions:
Eating Rate
Eligibility:
All Genders
21-50 years
Phase:
NA
Brief Summary
The aim of this balanced-order block randomized controlled cross-over trial with 2 treatment arms is to determine the effect of eating rate (ER) of ultra-processed food diets (UPF fast ER vs UPF slow ...
Detailed Description
Rationale: Consumption of industrially processed foods has been associated with obesity and related adverse health outcomes. If this reflects a causal relationship, it is unknown what attributes or pr...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, a participant must meet all of the following criteria:
- Between 21-50 years old at the day of inclusion
- Being able to read and understand English
- BMI 21-27 kg/m2
- Good general and mental health and appetite (self-report)
- Commonly (5 out of 7 week days) eating three meals a day around approximately the same times (self-report).
- A potential participant who meets any of the following criteria will be excluded from participation in this study:
- Based on the information meeting:
- Difficulties with swallowing, chewing and/or eating in general
- Suffering from an endocrine or eating disorder, gastrointestinal illness or illness of the thyroid gland, cardio-vascular diseases, bowel diseases, respiratory disease, neurological diseases, or diabetes, anaemia, cancer, or psychiatric conditions such as clinical depression, burnout or anxiety or bipolar disorder.
- Having a history of low blood pressure
- Having taste or smell disorders (self-report)
- Braces (not including a dental wire) or oral piercing
- Followed an energy restricted diet during the last 2 months
- Currently using or in the past 3 months (calculated from the first day of the study) used prebiotics supplements, probiotic supplements and/or antibiotics
- Gained or lost 5 kg of body weight over the last half year
- High restrained eater (DEBQ restrained eater scale ≥ 2.90 for males and ≥ 3.40 for females \[23\])\*
- Use of medication, including but not limited to hormone therapy or medications that affect the immune system or any medication that influences study outcomes such as food intake, appetite in general or metabolic responses (self-report)
- Consuming on average more than 21 (men) or 14 (women) glasses of alcohol per week
- Pregnant or lactating women, or women who are planning on becoming pregnant within the study period.
- Smoking (daily)
- Not willing to stop using drugs during the study period (from inclusion till last test session)
- Not willing to stop consuming alcohol during the intervention weeks
- Exercising more than 4 hours per week (excluding biking and walking at a normal pace and distance)
- Following a vegetarian or vegan diet
- Allergies or intolerance to any ingredient of the test meals
- Not willing to eat the test food because of eating habits or believes
- Do not like \> 20% of the test foods or its ingredients based on descriptions of the meal (scoring items ≤ dislike on a nine point hedonic scale)\*
- Majority \> 50% of dietary food intake (g) is derived from ultra-processed foods (based on a food frequency questionnaire (FFQ) based on normative data collected in pre-trial.\* The 50% cut-off is based on median intake of UPFs in Dutch cohort studies \[24\] \[25\]
- Being unfamiliar with \> 25% of the test meals
- Signed up for participating in another research study
- Being an employee or thesis student of the Division of Human Nutrition and Health at Wageningen university
- Radiological investigation during past 7 days where iodine or barium containing contrast fluids have been used (DEXA contra-indication)
- Nuclear medical investigation involving isotopes during past 7 days (DEXA contra-indication)
- Exclusion after screening:
- Haemoglobin value is not between 7.5-11.0 mmol/L (women), 8.5-11.0 mmol/L (men)
- Fasted glucose level is below \< 3.5 mmol/L or higher than 8 mmol/L
- Blood pressure is below 90/60 mm hg (below 90 and/or below 60 mm hg)
- Veins are not suited for blood sampling (as judged by trained research nurses)
- Persons with an extremely fast or slow eating rate trait, (\> 2 times the SD from the median, based on the carrot test \[26\] eating rate distribution based on data collected in previous studies in the same study population (unpublished).
- Persons with little difference (\< 20%) in the eating rate of a hard or soft carrot
- Do not like \> 20% of the test foods based tasting small portions (1 bite) of each of the meals (scoring items below ≤ dislike on a nine point hedonic scale)\* \* This exclusion criterion will not explicitly be communicated to the participants to prevent desirable answers
Exclusion
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2024
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT06113146
Start Date
October 2 2023
End Date
November 4 2024
Last Update
November 6 2024
Active Locations (1)
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1
Wageningen University
Wageningen, Gelderland, Netherlands, 6708 WE