Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04272749 |
| Other study ID # |
2019-059 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 16, 2019 |
| Est. completion date |
December 2021 |
Study information
| Verified date |
January 2021 |
| Source |
Clinical Nutrition Research Center, Illinois Institute of Technology |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The objectives of this study are to:
1. Investigate and describe perceptions of nutrient content, including calories, of
plant-based milks and dairy milks without food labels (ie., no Ingredient or Nutrition
Facts label) and how this impacts consumption choice.
2. Determine understanding of nutrient content, including calories, of plant-based milks
and dairy milks after given access to food labels (ie., Ingredient or Nutrition Facts
label) and how this impacts consumption choice.
3. Assess influence of age, gender, economic status, and race/ethnicity on results.
Description:
The proposed study is to evaluate the nutrient content understanding of subjects before and
after exposure to nutrition facts and ingredients list labels, along with the decision-making
behind consumption choices. Before the activity, subjects will complete a consumer choice
questionnaire and an eating habits questionnaire, which evaluates grocery shopping patterns
and typical 'milk' beverage preferences of subjects prior to participation in the activity.
Subjects will be presented with several 'milk' products in a four-section activity. Carton
set-up will vary between sections in terms of number and order. The order the cartons will be
set up on the tables will be randomized for each subject in order to avoid having results
attributed to the order the cartons are seen. In order to make a smooth randomization
process, each carton with has a number sticker on it, such as '#1' '#2' and so on. If carton
'#1' is almond milk in section I, it will remain carton '#1' for all subjects during section
I - only the order that the cartons are placed will change. Each of the four sections of the
activity will take place in its own cubicle. Subjects will be able to look at, move around,
and compare cartons while answering questions for that section's respective questionnaire
booklet. There will be no time limit on questionnaires. Questions in the booklet will be
separated onto different pages in order to prevent subjects from looking back at previous
answers and/or changing answers due to surrounding questions. Questionnaires throughout the
four sections will assess consumer perceptions of nutrient content of 'milk' beverages before
and after exposure to nutrition labels, exposure to varieties of 'milk,' and an ingestion
component - the requirement to choose one smoothie in front of a 'milk' carton to consume.
All cartons will remain unbranded throughout the activity. The difference between labeled and
unlabeled cartons will be only the presence or absence, respectively, of a nutrition facts
table and ingredients list on the side of the carton.
II. Study Subjects Subjects will be recruited through online advertisements, flyers
distributed throughout the university and local communities, and word of mouth. Interested
individuals can either click a link or scan a QR code to a secure online pre-screen survey
available in online advertisements and on flyers, or will be directed to the secure online
pre-screen survey by phone and/or email through using the contact information provided to the
subject on the online advertisements and flyers. Based upon this initial screening outcome,
subjects will be contacted to schedule their study visit. Upon arrival to the study visit,
subjects will have their birth date and hunger level confirmed by study personnel. Hunger
level will be analyzed through a Visual Analogue Scale (VAS) question. Subjects that mark a
vertical line on the VAS that is under 25mm or over 75mm, meaning extreme fullness or extreme
hunger, respectively, will be dismissed from the lab and are able to return at another time.
One hundred (n=100) subjects will be recruited.
III. Study Procedures Recruited subjects must meet all eligibility criteria (age requirement,
no allergies that could produce bias in choice during this study); sign and date a written
Institutional Review Board (IRB) approved Informed Consent Form prior to any study
procedures, and be willing and able to comply with study schedule and procedures. Subjects
will also be asked to fast for two (2) hours before coming to our site - this means no eating
or drinking other than water. During the screening visit, which includes confirming age and
collecting basic health information (weight, height, body composition), participants will
also complete questionnaires relating to eating habits and choice patterns in purchasing,
including general questions about dairy milks and plant-based milk alternatives to assess
consumption preferences. These will not be used for exclusion, but rather to characterize
population included in the study from a general health standpoint. These answers will allow
for understanding of selection bias when comparing those who do and do not complete the
study. Subjects will be required to drink a smoothie containing strawberries and banana
during their visit at the CNRC.
IV. Study Visit After completion of the initial online pre-screen questionnaire, eligible
subjects will be provided the option to schedule a study visit time, meaning a time to come
into the CNRC to complete the study.
The activity portion will be divided into four sections. Throughout this study, font, font
size, and color will be standardized among all cartons. In the first section, the participant
will be presented with five brand-less, unlabeled cartons: each of the five cartons will have
only one of either a cow, almond, soy, rice, and coconut sticker on them, along with a number
given to each carton for randomization purposes. In this section, the varieties in
plant-based milk alternatives (sweetened and unsweetened) and the varieties in dairy milks
(whole, 2%, 1%, and skim) will not be shown. A questionnaire booklet will be given to
subjects, which will ask about word associations (the first words or phrases that come to
mind when thinking of each type of 'milk' beverage) and preferences. This section serves to
assess opinions on the beverages in the absence of variety and nutrition labeling. The second
section introduces variety in that 12 brand-less, unlabeled cartons will have only a name and
number sticker on them: whole, 2% fat, 1% fat, skim, unsweetened almond, sweetened almond,
unsweetened coconut, sweetened coconut, unsweetened soy, sweetened soy, unsweetened rice, and
sweetened rice will be shown. A questionnaire will be given to subjects, which will ask about
preferences and nutrient content associations, along with interfering questions that are
still of interest in order to avoid asking the nutrient association questions immediately
after one another. The third and fourth sections will have the same 12 brand-less cartons,
except all cartons will now have a nutrition facts and ingredients list label on their side.
A questionnaire booklet will ask about preferences and potential standout information to the
subject after the viewing of the nutrition labels. In the fourth section, the questionnaire
booklet will ask about preferences and see if the decision-making process to consume a 'milk'
beverage differs from that of only hypothetically choosing a 'milk' beverage. There will be a
strawberry banana smoothie in a cup in front of each of the 'milk' cartons and subjects will
answer the section's questionnaire before consuming the smoothie of their choice. Only the
fourth section of the activity will require consumption of a 'milk' beverage; sections one,
two, and three will not involve any smoothie consumption. Subjects will consume 2 ounces (oz)
of the beverage they choose. These beverages will all be made of the same recipe containing
strawberries, bananas, and water in the metabolic kitchen using appropriate standard food
safety protocols. Each of the various 'milk' cartons will have a smoothie placed in front of
it so that the subject chooses the smoothie they associate with that particular 'milk'
carton. The second section will assess consumer opinions in the presence of variety without
exposure to nutrition labeling, the third section will assess those opinions after exposure
to nutrition labeling, and the fourth section will assess if those opinions differ when
ingestion is added into the activity. Each subject will go through sections 1-4 in the same
order. Upon completion of the activity, subjects will complete a post-screen to re-assess
nutrient associations and opinions on dairy milk and plant-based milk alternatives after the
activity compared to before the activity.
