Effects of Food Form and Fitness on Appetite and Digestion.

July 22, 2011 updated by: Purdue University
Energy-yielding fluids induce weaker appetitive and compensatory dietary responses than energy-matched semi-solids or solids. This is problematic because the high and increasing contribution of energy from beverages in the diet may enhance positive energy balance and weight gain. The prevailing view of the overweight/obesity problem is that it stems from a small, sustained positive energy balance. It follows then that only small changes, perhaps manipulations in the rheological characteristics of the diet, will be required to correct the problem. Certain populations that are more prone to weight gain may benefit from such manipulations. Obese individuals have a higher beverage intake and experience greater weight loss with reductions in beverage intake. Further, there is evidence that obese individuals consume more energy after a liquid pre-load than their lean counterparts, yet there is no difference in energy intake after a solid load. In contrast, habitual exercisers have been shown to have an increased accuracy of short-term regulation of food intake at meals following liquid preloads. A better understanding of the mechanisms by which beverages and energy-matched solid food forms elicit differential appetitive and dietary responses in these populations needed. This research will attempt to identify the influence of physical fitness and body fat on the ability to compensate for the energy content of solid and liquid preloads by reduction in energy intake at a subsequent ad libitum meal (i.e., acute compensation) and over the course of the day (i.e., short-term compensation). Furthermore, this study will examine the cognitive contribution to differential responses to energy-matched beverage and solid food forms and the effects of mastication on appetite, GI transit, glycemic response, and selected endocrine responses.

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.

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.
81

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
    • Indiana
      • West Lafayette, Indiana, United States, 47907
        • Purdue University

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-50 years of age BMI of 18-23 kg/m2 (lean) or 30-35 kg/m2 (obese) Sedentary physical activity level (<70th¬ percentile of estimated VO2max for age and sex) or physically Active/Exercisers (>70th¬ percentile of estimated VO2max for age and sex) Good health and not taking any medications known to influence appetite Non-smokers Not pregnant or lactating Weight stable (≤ 3 kg within last 3 months) Dietary restraint score <11 on the Three Factor Eating Questionnaire (included in the on-line screening questionnaire) Glucose Tolerant or Non-Diabetic (fasting blood glucose of <100 mg/dL) Self-reported consumer of breakfast and lunch

Exclusion Criteria:

  • History or presence of significant metabolic diseases that may impact study results (i.e., endocrine, hepatic, renal disease) Individuals planning on starting a new diet or exercise regimen during the course of the study Use of obesity pharmacotherapeutic agents or over-the counter anti-obesity agents within the last 3 months Underlying conditions such as any cardiovascular, pulmonary, or neurological dysfunction that may be aggravated with exercise

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: None (Open Label)

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.
Experimental: liquid to liquid,
Behavioral: liquid to liquid
• One test session will involve presentation of a glass of clear cherry-flavored unthickened beverage (Kool-Aid, Kraft Foods Inc., White Plains, NY). This session will be referred to as the "Liquid to Liquid" session as the participants will be consuming a liquid and be told that the consistency in their stomach will be a liquid.
Other Names:
  • Liquid test load
Experimental: liquid to solid,
Behavioral: liquid to solid
This session involves a solution of calcium chloride and a solution of sodium alginate. The participant will be instructed to pour the cherry-flavored beverage/alginate solution into the calcium chloride. The result is a solid mass. They are allowed to examine the solution to confirm the solid texture and consistency.Participants will be told that this same reaction will occur in their stomach when the session's beverage is consumed due to the effect of gastric acid on the solution. But, the participant will be consuming the same cherry-flavored beverage as in the 1st session. Thus, they will believe that their GI tract will be challenged with a solid mass, but in reality, the challenge is the same (i.e., liquid).Therefore, the only difference between the test sessions is expectation.
Other Names:
  • liquid test load
Experimental: solid to liquid
Behavioral: solid to liquid
• This session will involve the same dense gelatin cubes previously described, but participants will be told that the solid cubes will turn to liquid when they come into contact with the acid in their stomach. This trial will be known as "Solid to Liquid". A demonstration of the "Solid to Solid" and "Solid to Liquid" phases will be shown to the participant before they consume the load. Both phases exhibited by placing two cubes into separate containers filled with similar looking clear liquids. The "Solid to Solid" phase container will contain cold water so the cube stays in solid form. The "Solid to Liquid" phase container will contain hot water that will quickly dissolve the cube into a liquid form.
Other Names:
  • liquid test load
Experimental: solid to solid
Behavioral: solid to solid
Participants will be presented with dense gelatin cubes. These 1" x 1" x 1" cubes will have a solid appearance and require mastication, but is isocaloric to the beverage. However, after mastication and gastric processing, the solid rapidly breaks down into a clear fluid.However, participants will be informed that the cubes will remain the same solid consistency in their stomach. The masticatory process and stimulus form will be standardized through the use of a metronome. Participants will be required to chew the solid cube at a fixed rate prior to swallowing. Thus, adding to the cognitive impression that they are eating a solid when essentially the GI challenge will be similar to the beverage.
Other Names:
  • liquid test load

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
Change of energy intake.
Time Frame: 24 hours
Effects of actual and perceived food form on short term energy intake in lean and obese, fit and unfit adults.
24 hours

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
Change of appetite.
Time Frame: 4 hours
Effects of actual and perceived food form on hunger, fullness, desire to eat, and thirst.
4 hours
Gastric emptying
Time Frame: 4 hours
Effects of actual and perceived food form on gastric emptying time.
4 hours
Gastro-intestinal transit
Time Frame: 4 hours
Effects of actual and perceived food form on gastro-intestinal transit time.
4 hours
Endocrin responses
Time Frame: 4 hours
Effects of actual and perceived food form on GLP-1, CCK, Insulin, Ghrelin concentration.
4 hours
Glucose response
Time Frame: 4 hours
Effects of actual and perceived food form on serum glucose concentration.
4 hours

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.
Purdue University

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.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

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.
January 1, 2009

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 1, 2009

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 1, 2010

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).
February 16, 2010

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.
February 16, 2010

First Posted (Estimate)

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.
February 17, 2010

Study Record Updates

Last Update Posted (Estimate)

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 25, 2011

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 22, 2011

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, 2011

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.
  • R01DK079913 (U.S. NIH Grant/Contract)
  • 0805006922 (Other Identifier: Purdue University)

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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