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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
178

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • Leicestershire
      • Sutton Bonington, Leicestershire, United Kingdom, LE12 5RD
        • University of Nottingham Sensory Science Centre

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard tortilla chip for Sensory Study
Snack comparable to marketed version
Other: Tortilla corn chips 4-5 pieces, eat one piece at time
Snack
Experimental: Thicker than standard tortilla chip with same amount of seasoning per 100g for Sensory Study
Snack
Other: Tortilla corn chips 4-5 pieces, eat one piece at time
Snack
Active Comparator: Standard extruded chip for Sensory Study
Snack comparable to marketed version
Other: Extruded corn chips 4-5 pieces, eat one piece at time
Snack
Experimental: Bigger extruded chip with same seasoning per 100g for Sensory Study
Snack
Other: Extruded corn chips 4-5 pieces, eat one piece at time
Snack
Experimental: Bigger extruded chip with same concentration of seasoning on surface per 100g for Sensory Study
Snack
Other: Extruded corn chips 4-5 pieces, eat one piece at time
Snack
Active Comparator: Standard tortilla chip for Ad libitum Study
Snack comparable to marketed version
Other: Tortilla corn chips 90 grams
Snack
Experimental: Thicker than standard tortilla chip with same seasoning per 100g for Ad libitum Study
Snack
Other: Tortilla corn chips 90 grams
Snack
Active Comparator: Standard extruded chip for Ad libitum Study
Snack comparable to marketed version
Other: Extruded corn chips 90 grams
Snack
Experimental: Bigger extruded chip with same seasoning per 100g for Ad libitum Study
Snack
Other: Extruded corn chips 90 grams
Snack
Experimental: Bigger extruded chip with same concentration of seasoning on surface per 100g for Ad libitum Study
Snack
Other: Extruded corn chips 90 grams
Snack

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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..
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.
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
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PepsiCo Global R&D

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 14, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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