The primary objective of this study is to determine the role of eating rate of ultra-processed food (14 day) diets in moderating ad libitum energy intake over time.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
overgewicht en obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome measure is the average (across two weeks) daily energy intake
(kcal/day) in each diet arm
Secondary outcome
Secondary study parameters include: food (gram) ,energy (kcal) and nutrient
(gram, EN%) intake in gram and kcal on the level of the food, meal day and
week, pre-, and post meal appetite, body weight and body composition changes
and distribution fat mass vs fat free mass, changes in postprandial hormone
responses and respiratory quotient to a mixed meal tolerance test as a marker
of metabolic flexibility, changes in blood pressure, continues glucose levels
and long term satiety hormones (leptin, ghrelin),
Background summary
Consumption of industrially processed foods has been associated with obesity
and related adverse health outcomes. Yet it is unknown what properties of
industrially processed foods drive this association. Extensive research has
shown that foods that can be consumed more quickly, lead to higher food intakes
and this has been suggested as one of the ways in which processed foods promote
excess in calorie intakes. We therefore hypothesize that food texture moderates
energy intakes from processed foods.
Study objective
The primary objective of this study is to determine the role of eating rate of
ultra-processed food (14 day) diets in moderating ad libitum energy intake over
time.
Study design
We will conduct a randomized controlled cross-over trial with 2 treatment arms,
examining the effects of a ultra-processed slow eating rate (UPFslow) diet
versus a ultra-processed fast eating rate (UPFfast) diet on ad libitum energy
intake. The study will have a run-in period to determine habitual dietary
habits (baseline) and a washout period in between the two treatments to prevent
carry-over effects. All participants will receive both treatments and are their
own control (within participant design).
Intervention
The two treatments are 1) a 14-days ultra-processed slow eating rate diet, and
2) a 14-days ultra-processed fast eating rate diet. During the treatment period
participants will eat all of their main meals in the research diner room on
week days and will receive pre-packed meals to consume at home for the
weekends. Meals will be served ad-libitum, meaning in portions that are > 200%
of a regular portion size. Participants are asked to eat until they feel
comfortably full. In between the treatment periods there will be a 14-day
wash-out period.
Study burden and risks
The risk associated with participation is negligible and the burden can be
considered as high. Participant have to attend one information session, a
screening and will participate in a baseline week, two times a 2 week
intervention period, and a 2 week washout period. During the intervention
weeks, participants have to consume all of their main meals at the study site
on week days. During the weekends of the intervention period participants will
be asked to consume only the pre-packed weekend meals and bring back the
remaining after the weekend. Participants will be asked to wear a glucose
monitor during the two- 2 week intervention periods. During the baseline,
intervention and washout weeks participants will be asked to wear an
accelerometer and during the baseline and washout week they will be asked to
log their dietary intake in an app. Additionally we will collect different
types of bio-samples (blood, feces faecal and urine) which is burdensome for
the participant to collect. Participants will receive financial compensation
for their time and effort and will receive free meals for a total duration of 1
month. In demonstrating the impact of eating rate in moderating energy intakes
from processed foods, the project will provide *design rules* on the
application of texture to different product portfolios, and encourage the
application of texture innovations to slow the rate of calorie intake. To
summarize, this project provides insight in whether or not processed foods can
be part of healthy diet or whether some foods may be avoided or (re)formulated
to ultimately promote health and prevent chronic diseases.
stippeneng 4 stippeneng 4
Wageningen 6708 WE
NL
stippeneng 4 stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
Inclusion 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).
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, 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 pictures and descriptions of the meal (scoring items <=
dislike on a nine point likert 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 - 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: - HB 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 little difference (< 20%) in the eating rate of a hard and 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
Likert scale)* * This exclusion criterion will not explicitly be communicated
to the participants to prevent desirable answers
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83462.091.23 |