- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06691958
Impact of Chip Thickness and Size on Eating Responses
May 2, 2025 updated by: PepsiCo Global R&D
To analyze prototypes developed with the base and seasonings of products that exhibit variations in chip thickness and size.
The information obtained from this analysis will serve as the basis for subsequent research to explore different prototype options with increased satiation properties.
Study Overview
Status
Completed
Detailed Description
There are two study components, a sensory study and an ad libitum study.
Eighty-eight participants will test tortilla chips and eighty-eight will test extruded chips in the sensory study.
On a first-come first-served basis, forty-four of the eighty-eight chip participants from the sensory testing phase will test tortilla chips, and forty-four of the eighty-eight extruded chip participants will test extruded chips in the ad libitum study.
Study Type
Interventional
Enrollment (Actual)
178
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Leicestershire
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Sutton Bonington, Leicestershire, United Kingdom, LE12 5RD
- University of Nottingham Sensory Science Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Report eating tortilla and/or extruded chips regularly, non-rejector of cheese flavor chips
- Provide informed consent
- Speak and understand English without difficulty
- Willing to eat similar food the day prior and on the day of each visit to the testing facility for ad libitum sessions
- Describe yourself as generally healthy
Exclusion Criteria:
- Those who are on restricted diet due to a weight loss or maintenance purpose
- Participants with class III occlusions for ad libitum sessions
- Have abnormal taste, chewing and smell ability
- Smoke or vape
- Being pregnant or breastfeeding
- Allergic or intolerance to any of the product ingredients (section 6), especially milk and wheat
- Participation in a sensory clinical trial within past 7 days (we do not expect carryover issue from the taste testing)
- Participation in any PepsiCo trial within past 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard tortilla chip for Sensory Study
Snack comparable to marketed version
|
Snack
|
|
Experimental: Thicker than standard tortilla chip with same amount of seasoning per 100g for Sensory Study
Snack
|
Snack
|
|
Active Comparator: Standard extruded chip for Sensory Study
Snack comparable to marketed version
|
Snack
|
|
Experimental: Bigger extruded chip with same seasoning per 100g for Sensory Study
Snack
|
Snack
|
|
Experimental: Bigger extruded chip with same concentration of seasoning on surface per 100g for Sensory Study
Snack
|
Snack
|
|
Active Comparator: Standard tortilla chip for Ad libitum Study
Snack comparable to marketed version
|
Snack
|
|
Experimental: Thicker than standard tortilla chip with same seasoning per 100g for Ad libitum Study
Snack
|
Snack
|
|
Active Comparator: Standard extruded chip for Ad libitum Study
Snack comparable to marketed version
|
Snack
|
|
Experimental: Bigger extruded chip with same seasoning per 100g for Ad libitum Study
Snack
|
Snack
|
|
Experimental: Bigger extruded chip with same concentration of seasoning on surface per 100g for Ad libitum Study
Snack
|
Snack
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satiation: Intake in grams
Time Frame: Total grams consumed at each 30-minute ad libitum testing session from beginning of eating until end of eating on separate days, two test visits for tortilla chips arm and three test visits for extruded chips arm.
|
gram weight of consumption
|
Total grams consumed at each 30-minute ad libitum testing session from beginning of eating until end of eating on separate days, two test visits for tortilla chips arm and three test visits for extruded chips arm.
|
|
Satiation: Nutrition
Time Frame: Total calories consumed at each 30-minute ad libitum testing session from beginning of eating until end of eating on separate days, two test visits for tortilla chips arm and three test visits for extruded chips arm.
|
Intake in calories
|
Total calories consumed at each 30-minute ad libitum testing session from beginning of eating until end of eating on separate days, two test visits for tortilla chips arm and three test visits for extruded chips arm.
|
|
Duration of eating
Time Frame: Timed from beginning of eating until end of eating at each 30-minute ad libitum testing sessions on separate days, two test visits for tortilla chips arm and three test visits for extruded chips arm.
|
In minutes
|
Timed from beginning of eating until end of eating at each 30-minute ad libitum testing sessions on separate days, two test visits for tortilla chips arm and three test visits for extruded chips arm.
|
|
Rate of consumption
Time Frame: Measured in grams per minute at each 30-minute ad libitum testing session from beginning of eating until end of eating, on separate days, two test visits for tortilla chips arm and three test visits for extruded chips arm.
|
Speed of eating in minutes
|
Measured in grams per minute at each 30-minute ad libitum testing session from beginning of eating until end of eating, on separate days, two test visits for tortilla chips arm and three test visits for extruded chips arm.
|
|
Consumer response: Liking
Time Frame: At end of eating each product at the one 45-minute sensory session, and at end of each 30-minute ad libitum session on separate days, two visits for the tortilla chips arm and three visits for the extruded chips arm. Higher score is the better outcome.
|
9-point hedonic scale from extremely dislike to extremely like
|
At end of eating each product at the one 45-minute sensory session, and at end of each 30-minute ad libitum session on separate days, two visits for the tortilla chips arm and three visits for the extruded chips arm. Higher score is the better outcome.
|
|
Consumer response: Satisfaction
Time Frame: At end of eating each product at the one 45-minute sensory session and at end of each ad libitum session on separate days, two visits for tortilla chips arm and three visits for the extruded chips arm. Higher satisfaction is a better outcome.
|
9-point hedonic scale from extremely dissatisfied to extremely satisfied
|
At end of eating each product at the one 45-minute sensory session and at end of each ad libitum session on separate days, two visits for tortilla chips arm and three visits for the extruded chips arm. Higher satisfaction is a better outcome.
|
|
Perceived sensory properties (TCATA)
Time Frame: Over a period of 60 seconds for each product at the one 45-minute sensory session and at each ad libitum session on separate days, two visits for tortilla chips arm and three visits for the extruded chips arm.
|
Using Temporal CATA (TCATA) choose all that apply from list of crunchy, hard, tooth clogging, loose particles, soft, airy melting
|
Over a period of 60 seconds for each product at the one 45-minute sensory session and at each ad libitum session on separate days, two visits for tortilla chips arm and three visits for the extruded chips arm.
|
|
Perceived sensory properties (CATA)
Time Frame: Check all that apply for each product while sampling them at the one 45-minute sensory session. A favorable rating would be a better outcome.
|
CATA
|
Check all that apply for each product while sampling them at the one 45-minute sensory session. A favorable rating would be a better outcome.
|
|
Emotional responses using CATA
Time Frame: Check all that apply for each product while sampling them at the one 45-minute sensory session. Positive ratings would be a better outcome than negative..
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Essence 25 using CATA
|
Check all that apply for each product while sampling them at the one 45-minute sensory session. Positive ratings would be a better outcome than negative..
|
|
Hunger and Fullness and how much could you eat right now
Time Frame: Before eating and right after eating as much as they want to eat at each 30-minute ad libitum session on separate days, two visits for tortilla chips arm and three visits for the extruded chips arm.
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Using a 3 item Visual Analog Scale (VAS) to mark along 100 mm line the level of hunger and fullness from not at all to totally full
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Before eating and right after eating as much as they want to eat at each 30-minute ad libitum session on separate days, two visits for tortilla chips arm and three visits for the extruded chips arm.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exploratory measure: Relationship between chewing behavior and textural profile
Time Frame: At each ad libitum eating period at each 30-minute ad libitum session on separate days, two visits for tortilla chips arm and three visits for the extruded chips arm.
|
Audio/video recording of jaw movement analyzed by software vs. self-reported snack texture by survey
|
At each ad libitum eating period at each 30-minute ad libitum session on separate days, two visits for tortilla chips arm and three visits for the extruded chips arm.
|
|
Exploratory measure: Relationship between facial movement and self-reported emotional response
Time Frame: At each ad libitum eating period at each 30-minute ad libitum session on separate days, two visits for tortilla chips arm and three visits for the extruded chips arm.
|
Audio/video recording of facial movement analyzed by software vs. self-reported emotional response by survey
|
At each ad libitum eating period at each 30-minute ad libitum session on separate days, two visits for tortilla chips arm and three visits for the extruded chips arm.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Qian Yang, PhD, University of Nottingham, Sensory Science Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 7, 2024
Primary Completion (Actual)
February 14, 2025
Study Completion (Actual)
February 14, 2025
Study Registration Dates
First Submitted
November 11, 2024
First Submitted That Met QC Criteria
November 13, 2024
First Posted (Actual)
November 18, 2024
Study Record Updates
Last Update Posted (Actual)
May 7, 2025
Last Update Submitted That Met QC Criteria
May 2, 2025
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEP-2409
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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