Human Nutrition Department,
Wageningen university
Information folder
[JELLYHEAD STUDY]
Research to study the effects of chewing
and taste on satiation
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Participant information
Subject information for participation
in medical scientific research
JellyHead study
Research to study the effects of chewing and taste on satiation
Introduction
Dear Sir,
You are kindly requested to take part in a medical-scientific study. Participation is
voluntary. Participation requires your written consent. Before you decide whether you
want to participate (in this study), you will be given an explanation about what the study
involves. Please read this information carefully and ask the investigator for an
explanation if you have any questions. You may also discuss it with your partner, friends
or family.
This study is performed by the Division of Human Nutrition of Wageningen University.
The Dutch organisation for scientific research (NWO) reimburses the expenses of the
study.
The Ethics Committee of Wageningen University has approved this study.
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Participant information
1. Purpose of the study
The purpose of this study is to investigate how eating behaviour and food
characteristics affect hormone levels and satiation. When visiting a fast food restaurant
people easily overconsume, eating more than half of the recommended daily energy
intake (overconsumption through fast food). Previous studies have been performed to
understand how and why this happens. These studies have shown that it has something
to do with the relation between food characteristics and eating behaviour.
This
relationship can be explained by satiety signals or hormones that are sent to the brain.
These signals usually cause you to stop eating however when eating fast food these
signals are not activated. When this happens you usually eat more than your body
actually needs (overconsumption).
During this study we will look at hormonal levels in your blood that signal satiation while
you chew. To be able to do so we will collect blood samples.
With this study we hope to better understand which signals are most important in
causing people to stop eating during a meal.
2. What participation involves
When you participate in this study you will visit the Helix building 124 of Wageningen
University 7 times:

1x you will join an information meeting which is also the first part of the
screening (if you immediately decide to participate in the study). After the
meeting it will be determined whether or not you are eligible to participate in the
training part of this study. The information meeting takes approximately 30
minutes.

1x you will join a training session which is also the second part of the screening
where we will determine whether you can participate in the test sessions of the
study. The training takes approximately an hour

5x you will visit the research centre for the actual test sessions. All sessions
take 1.5 hour.
Participating in this study will cost you 9 hours of your time in total (including the
information meeting and training). The training and tests sessions will be spread out
over multiple weeks.
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Participant information
Information meeting and first part of the screening
There will be two moments during which we will decide whether you are eligible to
participate in this study. If you decide to participate after joining the information meeting
we will ask you to sign an informed consent. After you have given your consent by
signing the form we will give you a short questionnaire for you to fill in. This
questionnaire contains questions about your health, and questions about your age,
gender and food preferences. After you have filled in this questionnaire we will give you
another questionnaire with questions about your eating behaviour.
When you have finished filling in the questionnaires we will give you some of the model
foods or gels that we use in the study for you to taste and to rate on liking. The gels are
made from commercially available food products and are similar to pudding or panna
cotta.
This will be the first part of the screening, after the information meeting we will contact
you by email or phone to let you know whether you are eligible to participate in the
training session of the study which is also the second part of the screening.
Training and second part screening
When found eligible during the first part of the screening we will schedule your training
session which is also the second part of the screening. The training takes approximately
an hour. During the training you will receive the same model foods or gels as during the
information meeting but now you will be asked to eat the gels in a certain way. We will
ask you to eat the gels as you would normally do but spit out the gel at the moment you
would normally swallow. During the training we will ask you to repeat this a couple of
times to learn how to chew the gel without swallowing small pieces of the gel.
During this visit we will also determine your weight, height and your haemoglobin (Hb)
blood levels. The blood screening sometimes reveals anemia, we will always tell you
about these findings. Further medical examination will be done by your own GP or
specialist. The costs of this will be charged to your own insurance. You may also be
healthy but may still not be eligible for participation.
During this visit we will also determine whether the veins of your arm are suitable for
blood collection.
In addition, during the training you will fill in a questionnaire where we will ask you about
your opinion on eating foods that are unfamiliar to you.
Based on this second part of the screening we will determine whether you are eligible to
participate in the test sessions of the study. You may be excluded from participation
after the training, however, you will receive part of the reimbursement.
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Participant information
Test sessions
For the test sessions you will visit the university (Helix building) 5 times during
approximately 6 weeks.
The test session visit will take 90 minutes and will be scheduled on Tuesday-Thursday
and you will always be scheduled on the same time. There are three time points during
which you will be able to do the test sessions, however we do want you to plan all 5 test
sessions at the same time slot. The time slots are from 10.30 till 12.00, from 13.0014.30 and from 15.30 till 17.00. You have to be available at the time slot of your
choosing at least once a week.
The following will take place:

We will insert a cannula (intravenous tube) in a vein of your arm (inner side of
your elbow) from which we can draw blood during the measurements. That way
we do not have to insert a needle every time we collect blood.

After that you will have a 30 minute break for the body to adjust to the tube in
your vein.

We will ask you to fill in a short questionnaire about your hunger and thirst
feelings.

During the measurements you will get instructions on a computer screen when
to eat a gel; you can spit out the gel at the moment you would normally swallow
(as you will practice during the training sessions). You will repeat this
approximately 15 times.

During chewing we will video record you to study your eating behaviour and we
will take blood drawings every couple of minutes.

We will again ask you to fill in a short questionnaire about your hunger and thirst
feelings.

25 minutes after you started chewing we will collect the last blood sample and
the cannula or tube in your arm will be removed.

Once the cannula is removed you will be invited to the lunch room where you will
receive a glass of water and bread with different toppings; cheese, ham, jam or
hazelnut spread. You can then eat until you are pleasantly full.

After that you will fill in one last questionnaire about your hunger and thirst
feelings.
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Participant information
3. What is expected of you
For this study we are looking for men who fulfil the following criteria:

You are male

generally healthy (according to your self-report
when filling in the health
questionnaire)

good appetite

between 18 and 35 years old

speak Dutch and/or English fluently, and understand Dutch and/or English without
difficulty

healthy weight (BMI 18.5-25 kg/m2).

non-smoker

no facial hair or willing to shave (due to facial markers (stickers) that wil be placed
for the video recording to determine eating behavior.)

eat a meal three times a day, every day around the same time.
You are unable to participate in this study if you:

Have dental pathologies such as known caries, full dentures or if you are planning
to undergo dental treatment during the study.

Have difficulties with swallowing, chewing and or eating.

Are suffering from an endocrine or eating disorder, gastrointestinal illness or illness
of the thyroid gland or diabetes.

Are suffering from taste or smell disorders (self-report).

Have braces (not including a dental wire) or oral piercing.

Consume on average more than 28 glasses of alcohol per week.

Use medication that might influence your hormone levels or medication of which
you notice or noticed in the past that it influences your appetite, taste, saliva
production, chewing behaviour or when these side effects are mentioned in the
description of your medication.

Have allergies or intolerance to any ingredient of the model foods or gel: whipped
cream, sugar, Natrena sweeteners (cyclamate and saccharin), jelly pudding powder
(Dr. Oetker), locust bean gum and carrageenan.

Have allergies or intolerance for the breakfast or lunch meal: Goedemorgen
breakfast drink Campina, ingredients: Milk, sugar, banana, kiwi, strawberry, wheat
and oats. Lunch meal: bread with butter and any of the following toppings; cheese,
ham, jam or hazelnut spread.

Are not willing to eat the model foods or ad libitum lunch or breakfast drink because
of eating habits, (religious) believes or vegetarianism.
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Participant information

Followed an energy restricted diet during the last 2 months.

Gained or lost 5 kg over the last half year.

Signed up for participating in another research study (with the exception of the
EetMeetWeet study).

Are an employee of the Division of Human Nutrition (Wageningen University)

Are a thesis student or intern at the chair group of Sensory Science and Eating
Behaviour (Wageningen University).
Whether or not you fulfil these criteria will be determined with use of the questionnaire
you will receive during the information meeting, after you have given informed consent
for participating in this study.
During the training which is also the second part of the screening we will determine
whether you are eligible to participate in the test sessions. After the training it is still
possible you are excluded from participation in the test sessions, however, you will
receive part of the reimbursement.
After the training you may not participate in the test sessions when



You are not able to expectorate the entire gel (i.e. you swallow small pieces of
the gel)
You have anemia
The veins of your arm are not suitable to insert the cannula (intravenous tube)
to draw blood
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Participant information
In order to perform the study it is important that you agree to do the following.
The agreements are that you:

Do not exercise intensively or drink alcoholic drinks 24 hours before each test
session.

Will eat the same evening meal (of your own choice), the evening proceeding
the test sessions and you will not eat or drink anything after 19 hrs except for
water.

Will keep a diary the day before the test session, in which you note down your
exercise (walking, biking etc.) and everything you eat and drink.

Drink a breakfast drink 4 hours preceding your arrival time for the test sessions
and after that you will not eat or drink anything.

Use the same manner of transport every time you visit the research centre.

Do not participate in another study expect for the EetMeetWeet study.
It is important you contact the researchers in case

You are feeling ill or have a cold before the training or test session

You no longer want to participate in the study

Your contact information changes (i.e. phone number)
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Participant information
4. Possible undesirable discomforts
Possibly you may experience discomfort when participating in this study. For example,
you may feel a little dizzy or nauseous before or during the tests sessions because of
not eating for 4 hours prior to the visit and the following blood drawings. However, we
do not expect you to experience discomfort while eating the gels as they are made from
commercially available ingredients such as whipped cream, sugar, Natrena sweeteners
(cyclamate and saccharin), jelly pudding powder (Dr. Oetker) and thickening agents
locust bean gum and carrageenan. These thickening agents can also be found in other
food products such as chocolate milk and pudding.
5. Advantages and disadvantages
You will not personally benefit from participating in this study. Your participation will
however contribute to knowledge about eating behaviour and over eating; in return you
will receive a reimbursement and 5 times a free lunch meal.
Disadvantages of participating in this study are:
-
The time it will cost you to participate in this study
-
The agreements you are required to oblige
-
Inserting the cannula (tube) from which we will withdraw blood may be a bit painful.
6. If you do not want to participate or you want to stop participating
in the study
It is up to you to decide whether or not to participate in the study. Participation is
voluntary.
If you do participate in the study, you can always change your mind. You
may stop participation at any time during the study. You do not have to say why you are
stopping, but you do need to tell the investigator immediately. The data collected until
that time will still be used for the study. If you want, any bodily material or personal
material collected such as the video recordings or blood samples can be destroyed.
If there is any new information about the study that is important for you, the investigator
will let you know. You will then be asked whether you still want to continue your
participation.
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Participant information
7. End of study
Your participation in the study stops when
 You completed all the visits as described under point 2
 You choose to stop
 The, government or Wageningen University decides to stop the study.
The study is concluded once all the participants have completed the study.
After processing the data, the investigator will inform you about the most important
results of the study. This will happen about a year after your participation.
8. Usages and storage of your data
For this study it is necessary to collect and use your video recordings, blood samples
and personal data. Each study subject will receive a code that will be marked on the
blood samples. Your name will be deleted. The blood samples will be destroyed after
analysing the hormone levels. In case we find blood levels that deviate from normal we
will share this with you and we will always recommend contacting your family doctor.
Video’s will also get a code, your name will not be mentioned. However videos cannot
be fully anonymous as you will be recognizable. Video’s will not be published or shared
with people not involved in the study. Videos will not be used for presentation purposes
without your consent. Researchers are only allowed to use your video’s for
presentations after you gave verbal and in written permission to do so.
Your data
All your data will remain confidential. The investigator is the only person who will know
which code you have. Some people may access your medical and personal data. This
is to check whether the study is good and reliable. People who may access your data
are people from the study team and people from health inspection. They will keep your
data a secret. If you sign the consent form, you consent to your personal data, blood
samples and video recordings being collected, stored and accessed.
Researchers will keep your personal data 15 years after collection of the results of the
study.
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Participant information
Use of video recordings
We would like to keep and save your video recordings for three years after the results of
the study are published. On the informed consent form you can indicate whether or not
you agree with this. You can always withdraw your consent, in which case the videos
will be deleted. After the videos are analysed and eating behaviour is determined the
results will be used for research.
9. Study subject insurance
This nutrition research study will be performed with products or ingredients that can be
used in daily life therefore we do not anticipate on negative side effects.
You may experience some discomfort due to the blood drawings. Because of the blood
sample collection insurance has been taken out for everyone participating in this study.
Information about the insurance can be found in attachment C.
11. Compensation for participation
When participating in the entire study you will receive a reimbursement of € 260, (including traveling costs). After the second part of the screening you will receive a
€ 10, - gift card, also when you are not found eligible to continue with the test sessions
of the study. When you finish the entire study (5 test sessions) you will receive € 250, on your bank account. If you stop before the study is over, you will receive a smaller
amount. This reimbursement should be communicated to the Tax Authorities as income.
You have to encounter 2-4 months before you will receive the money on your bank
account.
12. Any questions?
If you have any questions, please contact the study team ([email protected]). If you
would like any independent advice about participation in this study, you may contact the
independent physician. He knows about the study but is not involved in it. For studies
performed by the department of human Nutrition this is dr. J.J. van Binsbergen
(physician in Brielle).
Appendix A: Contact details.
Thank you for your attention.
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Participant information
13. Appendices to this information
A.
Contact details
B.
Informed consent forms
C.
Insurance information
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Participant information
Appendix A: contact details
Contact details research team
Principle investigator: Marlou Lasschuijt
Project leader: dr. Paul A.M. Smeets en dr. Ir. Monica Mars
Division of Human Nutrition, Wageningen University
E-mail: [email protected]
Visiting adress
Wageningen university
Helix (building 124)
Stippeneng 4
6708 WE Wageningen
Independent physician
The independent physician can be contacted for any questions related to this study
which you do not prefer to ask to the research team.
For the Division of Human Nutrition this is dr. J.J. van Binsbergen (physician in Brielle).
Phone number 0181-412155, can be reached on working days between 8 and 10 am.
You will hear a menu during which you will have to choose 2 ‘any other business’. The
assistant will write down your details and dr. van Binsbergen will contact you.
You can also ask your questions by email: [email protected]
Please, clearly indicate to the assistant which study you (intend to) participate in.
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Participant information
Appendix B: toestemmingsformulier proefpersoon JellyHead studie
Research study to the effects of chewing and taste on satiation:
-
I have read the subject information form. I was also able to ask questions. My
questions have been answered to my satisfaction. I had enough time to decide whether
to participate.
-
I know that participation is voluntary. I know that I may decide at any time not to
participate after all or to withdraw from the study. I do not need to give a reason for this.
-
I know that some people can access my data. These people are listed in this
information sheet.
-
I consent to my data, blood samples and video recordings being used in the way and
for the purpose stated in the information sheet
- I consent to my personal data being stored for another 15 years after this study.
- I consent to draw blood samples and storages thereof until analysed.
- I give permission to warn me if blood level values are outside the normal range by the
research nurse.
- I give permission to save my videos up to three years after publication of the results
□ yes
□ no
- I want to participate in this study
Name of study subject:
Signature:
Date:
__ / __ / __
----------------------------------------------------------------------------------------------------------------I hereby declare that I have adequately informed this study subject about this study.
If information comes to light during the course of the study that could affect the study
subject's consent, I will inform him/her of this in a timely fashion.
Name of investigator (or his/her representative):
Signature:
Date:__ / __ / __
----------------------------------------------------------------------------------------------------------------.
The study subject will receive the full information sheet, together with a copy of the
signed consent form.
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Participant information
Appendix C: INFORMATIE OVER DE VERZEKERING VOOR
DEELNEMERS
Wageningen university and research centre has taken out insurance for all
subjects participating in research of Wageningen university and research
centre.
The insurance covers damages caused by participating in research studies.
This applies to all damage done during the study or within four years after
participating. Damage has to be reported by the insurance company within four
years.
The insurance does not cover all damages. Below this paragraph a short
explanation states what damages are covered.
These provisions are contained in the Decree on compulsory insurance in
medical research involving human subjects. This decision can be found on the
following website www.ccmo.nl, the Central Committee on Research Involving
Human Subjects website (see "Library" and then "Laws").
In case of damage you can contact the insurance company directly
Insurance compagny:
Name:
HDI- Gerling Industrie Versicherung AG
Directie voor Nederland
Adress:
Postbus 925, 3000 AX Rotterdam
Phone number: 020 5650654
E-mail:
[email protected]
Polis number:
08150013-14006/72973741
Contactperson: M. Wijnsma (office Amsterdam)
The insurance provides coverage up to a maximum of € 650,000 per participant
with a maximum of € 5,000,000 per research. Here, a maximum of € 7,500,000
applies to all research at Wageningen UR per insurance year.
The insurance does not cover the following damage:
 damage from a risk which you are informed about on the written information
that has been given to you. This does not apply if the risk is more severe than
anticipated occurs or if the risk was very unlikely;
 damage to your health that would also have occurred if you had not
participated in the study;
 damage because of not following directions or instructions (completely);
 damage to your offspring, due to a negative impact of research on you or your
offspring;
 damage from an existing treatment method in research on existing
treatments.
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Participant information
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