The Effect of Dietary Fiber on Food Liking

July 13, 2019 updated by: Hollie Raynor, The University of Tennessee, Knoxville
This study will investigate the effects of different fermenting fibers on liking of foods.

Study Overview

Status

Status

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

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

Participants will be randomized to one of three orders to reduce the possibility of an order effect.The participants will be given a brownie specific for the condition they are in and then will be instructed to eat the brownie in 10 minutes. Twenty minutes after consuming the brownie participants will be served a lunch. Dependent variables will be food liking.

At the start of the session the participant will be asked to recall all foods and beverages consumed 24 hours prior to the scheduled appointment. During this recall if a participant reports consuming any foods or beverages besides water within 3 hours of the appointment, the appointment will be rescheduled. Participants will also be asked if they have participated in any physical activity 24 hours prior to their scheduled appointment. If the participant answers "yes," then the appointment will be rescheduled.

After completing hunger and fullness VAS, participants will be presented with a preload of brownie, β-glucan brownie, or psyllium brownie. The brownie will be prepared from the same base recipe, thus be of the same approximate energy and macronutrient composition, but differ in amount and type of dietary fiber. The base recipe will use a box of Pillsbury™ dark chocolate brownie mix, two eggs, ¼ cup water and 2/3 cup of Food Club™ unsweetened applesauce. The regular brownie will not contain any fiber, while the β-glucan and psyllium brownie will contain about 6 grams of their respective fiber: Bulk Supplements™ β-glucan and Frontier™ Psyllium Husk Powder. An additional tablespoon of water will be added to the β-glucan brownie mix. The brownie will be presented warm, with two tablespoons of Cool Whip™ fat free spread on top, with 6 ounces of water. The participants will be told to consume all of the brownie and toping, and to drink all of the 6 oz of water within 10 minutes. Next, participants will rate their hunger and fullness again with the VAS and sit quietly for 20 minutes reading current magazines (i.e., People, Entertainment Weekly). After 20 minutes, the participants will be presented with a sandwich (turkey or ham), chips, and grapes.The sandwich will be cut into quarters on a plate, the chips and grapes will be presented in two separate bowls. Following the presentation of the meal, participants will be instructed that they will have 20 minutes to eat as much or as little as they would like of the meal provided until satisfied, however they need to at least taste each of the foods. At the completion of 20 minutes, the lunch will be removed and the participant will be asked to complete a scale for evaluating levels of hunger, fullness, and liking of the foods.

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.
12

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 Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37996
        • Healthy Eating and Activity Laboratory, University of Tennessee

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 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index (BMI) between 18.5 to 24.9 kg/m^2
  • Unrestrained eater (<12 on Three Factor Eating Questionnaire [TFEQ])
  • report liking turkey or ham sandwiches, brownies, grapes, and potato chips (rate all items >50mm on a visual analogue scale [VAS]).
  • Report regularly eating before 10 am
  • Can completed all sessions within 6 weeks of the screening session.

Exclusion Criteria:

  • Report binge eating
  • Report a medical condition that influences eating
  • Report food allergies to the study foods
  • Currently smoke
  • Report dietary restrictions
  • Report not liking brownies
  • Report currently taking a medication that effects appetite
  • Report being pregnant or breast-feeding
  • Report being an athlete in training.

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.
Other: Regular Brownie
Regular Brownie For the regular brownie condition (RB), participants will consume the brownie preload and then consume a meal 20 minutes later.
Other: Eating
Participants will have 10 minutes to eat all of the brownie and drink 6 oz of water. They will then have 20 minutes to eat as much or as little of a meal (consisting of a sandwich, grapes and chips).
Other: Psyllium Brownie
For the psyllium brownie (PG), participants will consume a psyllium brownie and then consume a meal 20 minutes later.
Other: Eating
Participants will have 10 minutes to eat all of the brownie and drink 6 oz of water. They will then have 20 minutes to eat as much or as little of a meal (consisting of a sandwich, grapes and chips).
Other: β-glucan Brownie
For the β-glucan Brownie (BG), participants will consume a β-glucan Brownie preload and then consume a meal 20 minutes later
Other: Eating
Participants will have 10 minutes to eat all of the brownie and drink 6 oz of water. They will then have 20 minutes to eat as much or as little of a meal (consisting of a sandwich, grapes and chips).

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
Hunger
Time Frame: Change across the meal, 20 minutes
100 mm Visual analog scale
Change across the meal, 20 minutes
Fullness
Time Frame: Change across the meal, 20 minutes
100 mm Visual analog scale
Change across the meal, 20 minutes
Liking
Time Frame: Change across the meal, 20 minutes
100 mm Visual analog scale
Change across the meal, 20 minutes

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.
The University of Tennessee, Knoxville

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.
July 24, 2017

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.
May 30, 2018

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.
May 30, 2018

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).
July 25, 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.
August 2, 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.
August 7, 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.
July 16, 2019

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.
July 13, 2019

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.
July 1, 2019

More Information

Terms related to this study

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.
  • UTK IRB-17-03817-XP

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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