Assessing Consumer's Characterization of the Term Natural in a Food Context (NTR)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Food Order

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Clinical Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 20-65 years' old
• Able to provide informed consent and comply with study procedures

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Arm; Food Order: Randomly assigned orders of 7 bowls of granola, each with a different food label.	Behavioral: Food Order; randomly assigned orders of 7 bowls of granola, each with a different food label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One choice of 7 Label choices associated with the term 'natural'	Participant's choice of 7 Label choices associated with the term 'natural'	1 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of Food intake consumption according to label choices	Amount of Food intake consumption according to label choices	1 hours

Collaborators and Investigators

• Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology
• Investigators: Principal Investigator: Britt M Burton-Freeman, Illinois Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2017
• Primary Completion (Actual): December 28, 2018
• Study Completion (Actual): December 28, 2018

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: natural; Food Label Choices
• Other Study ID Numbers: IRB2017-042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No