HealthyNTRNCT03165162
Assessing Consumer's Characterization of the Term Natural in a Food Context
A study testing Food Order in people with Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
The purpose of this project is to gain a better understanding of the underlying consumer motivations associated with choosing foods labeled as "natural"; and further, how the use of this term impacts the amount of food consumed. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Food Order
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2017to 28 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 20-65 years' old
- Able to provide informed consent and comply with study procedures
Who cannot join
- Special dietary patterns that may interfere with study results
- Have allergies/intolerances to foods consumed in the study
- Have uncontrolled high blood pressure at screening visit
- Have uncontrolled elevated fasting blood glucose concentration at screening visit (≥126 mg/dL)
- History of eating disorder
- Planning to become pregnant, pregnant and/or breast-feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
The purpose of this project is to gain a better understanding of the underlying consumer motivations associated with choosing foods labeled as "natural"; and further, how the use of this term impacts the amount of food consumed.
Read the detailed description
This study is a randomized, 1-arm, parallel trial design focused on determining the types of food labels people associate with 'natural.' A planned sample size of 100 will be enrolled into the study. This study will require one initial screening visit and 1 Study Day. This study will take approximately 1 day to 1 week per subject to complete.
The initial screening visit will provide subject with the informed consent document and determine subject eligibility through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey relate to general eating, health, and exercise habits.
If willing and eligible to participate, subjects will be invited to participate in the study for 1 Study Day that participants can choose to continue on to after the Screening visit.
Subject will arrive at the center in a fasted. During the Study Day, each participant will be asked to complete a health and mindfulness questionnaire. After completing the questionnaire, participants will be confronted with 7 bowls of granola, each with a different food label. The participant will be asked to choose the most natural granola to eat with the yogurt. After the participant chooses, the participant will then have a selected amount of time to consume the food and then after complete a debrief questionnaire regarding their intake choice. Subjects will be randomized to receive the food items labelled in different orders. The sequences of receiving the food items will be randomly assigned to one of sequences.
- Conditions
- Healthy
- Being tested
- Food Order
- Keywords
- natural, Food Label Choices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food OrderBehavioural
randomly assigned orders of 7 bowls of granola, each with a different food label.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | Food Order: Randomly assigned orders of 7 bowls of granola, each with a different food label. Receives: Behavioral: Food Order |
What is being measured
The primary outcome is the main question the study is designed to answer.
One choice of 7 Label choices associated with the term 'natural'
Participant's choice of 7 Label choices associated with the term 'natural'
Measured: 1 hours
Secondary outcomes (1)
Amount of Food intake consumption according to label choices
Amount of Food intake consumption according to label choices
Measured: 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start22 May 2017
- Primary completion28 Dec 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Clinical Nutrition Research Center, Illinois Institute of TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Britt M Burton-Freeman, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165162
- Sponsor's protocol ID
- IRB2017-042
- Acronym
- NTR
- Status last verified
- Jul 2020
- First submitted
- 19 May 2017
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Consumer's Characterization of the Term Natural in a Food Context
- ClinicalTrials.gov ID
- NCT03165162
- Acronym / sponsor ID
- NTR / IRB2017-042
- Conditions
- Healthy
- Keywords
- natural, Food Label Choices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 22 May 2017 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to gain a better understanding of the underlying consumer motivations associated with choosing foods labeled as "natural"; and further, how the use of this term impacts the amount of food consumed.
Detailed description
This study is a randomized, 1-arm, parallel trial design focused on determining the types of food labels people associate with 'natural.' A planned sample size of 100 will be enrolled into the study. This study will require one initial screening visit and 1 Study Day. This study will take approximately 1 day to 1 week per subject to complete.
The initial screening visit will provide subject with the informed consent document and determine subject eligibility through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey relate to general eating, health, and exercise habits.
If willing and eligible to participate, subjects will be invited to participate in the study for 1 Study Day that participants can choose to continue on to after the Screening visit.
Subject will arrive at the center in a fasted. During the Study Day, each participant will be asked to complete a health and mindfulness questionnaire. After completing the questionnaire, participants will be confronted with 7 bowls of granola, each with a different food label. The participant will be asked to choose the most natural granola to eat with the yogurt. After the participant chooses, the participant will then have a selected amount of time to consume the food and then after complete a debrief questionnaire regarding their intake choice. Subjects will be randomized to receive the food items labelled in different orders. The sequences of receiving the food items will be randomly assigned to one of sequences.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Behavioral: Food OrderFood Order: Randomly assigned orders of 7 bowls of granola, each with a different food label. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 20-65 years' old
- Able to provide informed consent and comply with study procedures
Key exclusion criteria (6 listed)
- Special dietary patterns that may interfere with study results
- Have allergies/intolerances to foods consumed in the study
- Have uncontrolled high blood pressure at screening visit
- Have uncontrolled elevated fasting blood glucose concentration at screening visit (≥126 mg/dL)
- History of eating disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food Orderrandomly assigned orders of 7 bowls of granola, each with a different food label. | Behavioural | Study Arm |
Primary outcome
One choice of 7 Label choices associated with the term 'natural'
Time frame: 1 hours
Participant's choice of 7 Label choices associated with the term 'natural'
1 secondary outcome
Amount of Food intake consumption according to label choices
Time frame: 1 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britt M Burton-Freeman principal investigator
Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Order in people with Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One choice of 7 Label choices associated with the term 'natural' (time frame: 1 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.