Influence on Food Liking of Adding Spices to Replace Sugar Using CLT

March 19, 2018 updated by: University of Colorado, Denver

Influence of Food Liking of Adding Spices to Replace Dietary Sugar Using Sequential Monadic CLT Methodology

This study aims to reduce the amount of sugar in a particular food item and add spices to see if the food liking of that item rates as high or higher in a post meal survey. Through taste testing of the menu items (using sequential monadic CLT methodology) the investigators will determine an opinion of the participants. Results of these surveys will determine whether participants enjoy the reduced sugar options as much as their full sugar counterparts.

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

The investigators will compare the overall consumer acceptability of each of three test items (tea, oatmeal and apple crisp) across the three test conditions using central location test (CLT) and cross-over design. The three test conditions for each test item will be (1) Full sugar ("FS"), (2) reduced sugar (and calorie) with no added spice ("RS") and (3) reduced sugar (and calorie) plus spice ("RSS"). The two reduced sugar items will be matched for calories. Subjects will be provided the test items using sequential monadic CLT methodology (Central Location Test methodology which involves product evaluation after a brief exposure (one sample-subject contact) under standardized conditions whereby subjects are given each of the 3 recipes of each test item (e.g., oatmeal with full sugar, oatmeal with reduced sugar, oatmeal with reduced plus spice) back to back (all within one sitting) in a random order. The investigators are interested in using the sequential monadic CLT methodology and having subjects taste all 3 recipes of each item in one sitting which is a commonly used test modality for sensory studies.

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.
150

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

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-ages 18-65

Exclusion Criteria:

  • diagnosed taste or sensory disorder
  • known eating disorder
  • allergies to test food/ingredients
  • medical conditions that may adversely affect taste (ie: dysgeusia)
  • inability to complete protocol or to participate in all three taste testing sessions
  • personal dietary restrictions towards test items
  • dislike of the particular food items to be served in taste tests
  • subjects who do not consume foods or beverages that contain sugar or to which they have added sugar will be excluded
  • subjects who have not consumed or would not be willing to consume hot tea, oatmeal or baked apple products will be excluded
  • subjects who are pregnant or trying to become pregnant will be excluded

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

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: full sugar recipe

Each subject was randomly assigned to one of six possible sequences to taste three recipes of each test item (apple crisp, tea and oatmeal). The three recipes were full sugar recipe (FS), reduced sugar recipe (RS) and reduced sugar plus spice recipe (RSS). Each subject was randomly assigned to one of the below sequence schedules for each taste test whereby A, B, and C refer to one of the three recipes (FS, RS, or RSS):

Sequence 1: A, B, C Sequence 2: A, C, B Sequence 3: B, A, C Sequence 4: B, C, A Sequence 5: C, A, B Sequence 6: C, B, A
Other: Apple Crisp
Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe) of apple crisp in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted each recipe of an item at one sitting (ie: subject completed apple crisp tastings during one seating during first week, oatmeal tastings during one seating the next week and tea tastings during one seating the next and final week).
Other: Tea
Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe) of tea in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted each recipe of an item at one sitting (ie: subject completed apple crisp tastings during one seating during first week, oatmeal tastings during one seating the next week and tea tastings during one seating the next and final week).
Other: Oatmeal
Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe of oatmeal in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted each recipe of an item at one sitting (ie: subject completed apple crisp tastings during one seating during first week, oatmeal tastings during one seating the next week and tea tastings during one seating the next and final week).
Experimental: reduced sugar recipe

Each subject was randomly assigned to one of six possible sequences to taste three recipes of each test item (apple crisp, tea and oatmeal). The three recipes were full sugar recipe (FS), reduced sugar recipe (RS) and reduced sugar plus spice recipe (RSS). Each subject was randomly assigned to one of the below sequence schedules for each taste test whereby A, B, and C refer to one of the three recipes (FS, RS, or RSS):

Sequence 1: A, B, C Sequence 2: A, C, B Sequence 3: B, A, C Sequence 4: B, C, A Sequence 5: C, A, B Sequence 6: C, B, A
Other: Apple Crisp
Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe) of apple crisp in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted each recipe of an item at one sitting (ie: subject completed apple crisp tastings during one seating during first week, oatmeal tastings during one seating the next week and tea tastings during one seating the next and final week).
Other: Tea
Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe) of tea in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted each recipe of an item at one sitting (ie: subject completed apple crisp tastings during one seating during first week, oatmeal tastings during one seating the next week and tea tastings during one seating the next and final week).
Other: Oatmeal
Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe of oatmeal in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted each recipe of an item at one sitting (ie: subject completed apple crisp tastings during one seating during first week, oatmeal tastings during one seating the next week and tea tastings during one seating the next and final week).
Experimental: reduced sugar plus spice recipe

Each subject was randomly assigned to one of six possible sequences to taste three recipes of each test item (apple crisp, tea and oatmeal). The three recipes were full sugar recipe (FS), reduced sugar recipe (RS) and reduced sugar plus spice recipe (RSS). Each subject was randomly assigned to one of the below sequence schedules for each taste test whereby A, B, and C refer to one of the three recipes (FS, RS, or RSS):

Sequence 1: A, B, C Sequence 2: A, C, B Sequence 3: B, A, C Sequence 4: B, C, A Sequence 5: C, A, B Sequence 6: C, B, A
Other: Apple Crisp
Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe) of apple crisp in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted each recipe of an item at one sitting (ie: subject completed apple crisp tastings during one seating during first week, oatmeal tastings during one seating the next week and tea tastings during one seating the next and final week).
Other: Tea
Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe) of tea in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted each recipe of an item at one sitting (ie: subject completed apple crisp tastings during one seating during first week, oatmeal tastings during one seating the next week and tea tastings during one seating the next and final week).
Other: Oatmeal
Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe of oatmeal in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted each recipe of an item at one sitting (ie: subject completed apple crisp tastings during one seating during first week, oatmeal tastings during one seating the next week and tea tastings during one seating the next and final week).

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
Overall Liking of Apple Crisp
Time Frame: Day of taste testing
Overall liking of apple crisp with a 9-point hedonic rating scale instrument (whereby 0 = dislike extremely and 9 = like extremely )
Day of taste testing
Overall Liking of Tea
Time Frame: day of taste testing
Overall liking of tea with a 9-point hedonic rating scale instrument (whereby 0 = dislike extremely and 9 = like extremely )
day of taste testing
Overall Liking of Oatmeal
Time Frame: day of taste testing
Overall liking of oatmeal with a 9-point hedonic rating scale instrument (whereby 0 = dislike extremely and 9 = like extremely )
day of taste testing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ranking of Full Sugar Recipe of Apple Crisp
Time Frame: day of taste testing
Subjects ranked each recipe in order of likability as first, second or third.
day of taste testing
Ranking of Reduced Sugar Recipe of Apple Crisp
Time Frame: day of taste testing
Subjects ranked each recipe in order of likability as first, second or third.
day of taste testing
Ranking of Reduced Sugar Plus Spice Recipe of Apple Crisp
Time Frame: day of taste testing
Subjects ranked each recipe in order of likability as first, second or third.
day of taste testing
Ranking of Reduced Sugar Recipe of Tea
Time Frame: Day of taste testings
Subjects ranked each recipe in order of likability as first, second or third.
Day of taste testings
Ranking of Full Sugar Recipe of Tea
Time Frame: day of taste testing
Subjects ranked each recipe in order of likability as first, second or third.
day of taste testing
Ranking of Reduced Sugar Plus Spice Recipe of Tea
Time Frame: day of taste testing
Subjects ranked each recipe in order of likability as first, second or third.
day of taste testing
Ranking of Reduced Sugar Recipe of Oatmeal
Time Frame: day of taste testing
Subjects ranked each recipe in order of likability as first, second or third.
day of taste testing
Ranking of Full Sugar Recipe of Oatmeal
Time Frame: day of taste testing
Subjects ranked each recipe in order of likability as first, second or third.
day of taste testing
Ranking of Reduced Sugar Plus Spice Oatmeal
Time Frame: day of taste testing
Subjects ranked each recipe in order of likability as first, second or third.
day of taste testing

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.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
McCormick Science Institute

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: John C. Peters, PhD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
October 17, 2016

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.
December 9, 2016

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.
December 9, 2016

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).
April 26, 2017

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.
May 1, 2017

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.
May 4, 2017

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.
November 2, 2018

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.
March 19, 2018

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.
March 1, 2018

More Information

Terms related to this study

Keywords

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.
  • 16-1599

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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Drug Interventions

Conditions

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Drug Interventions

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