Protein Quality on Appetite Control, Reward-driven Eating, & Subsequent Food Intake

April 30, 2019 updated by: Heather Leidy, University of Missouri-Columbia

The Effects of Consuming Beef vs. Soy-rich Lunch Meals, Matched for Macronutrient Content or Serving Size, on Markers of Appetite Control and Satiety

To determine whether the consumption of a beef-rich lunch improves appetite control, satiety, and energy intake regulation while reducing food reward and food cravings compared to the consumption of a soy-rich lunch when matched for macronutrients and fiber content or when match for serving size. The mechanisms of action surrounding the differential responses of beef versus soy proteins were also explored.

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

A randomized, crossover design, acute study was completed in 21 healthy adults (age 23 ±1 y; BMI: 23.8 ± 0.6 kg/m2) to compare 400 kcal lunch meals varying in protein quality. Two separate comparisons were performed. The first comparison consisted of macronutrient and fiber-matched lunches which varied in protein quality: 24 g beef protein vs. 24 g soy protein. The second comparison matched serving size only: 1 serving of beef (24 g protein with 0 g fiber) vs. 1 serving of soy (14 g protein; 5 g fiber). For each treatment, the participants completed 2 testing days per lunch treatment. During the "Appetite Assessment Days," each participant reported to the lab to consume one of the lunch meals. Pre and 7-h post-lunch appetite and cravings questionnaires were completed throughout each testing day along with plasma, hormonal responses, and plasma amino acid concentrations through repeated blood sampling. Ad libitum dinner energy intake was also measured. During the "Reward Assessment Days," the participants reported to our facility to again consume one of the lunch meals. Pre and post-lunch neural responses to food stimuli, through functional magnetic resonance imaging (fMRI), occurred followed by ad libitum consumption of a lunch dessert.

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.
21

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
    • Missouri
      • Columbia, Missouri, United States, 65211
        • University of Missouri

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 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age range 18-30 y
  • Normal to Overweight (BMI: 18-29.9 kg/m2)
  • No metabolic, psychological, or neurological diseases/conditions
  • Not currently/previously on a weight loss or other special diet (in the past 6 months)
  • Not a vegetarian
  • Right-handed (necessary for the fMRI analyses)
  • Not pregnant
  • Meets the MU-Brain Imaging Center Screening Criteria
  • Have not given blood (for the American Red Cross in the past 6 months)

Exclusion Criteria:

  • Age >30 y and <18y
  • Under Weight or Obese (BMI: <18 kg/m2 or >29.9 kg/m2)
  • Clinically diagnosed with diabetes (Type I or Type II), having an eating disorder, or having any other metabolic, psychological, or neurological diseases/conditions that would influence the study outcomes.
  • Currently/previously on a weight loss or other special diet (in the past 6 months)
  • Left-handed
  • Claustrophobic (≥ 2 past bouts of claustrophobia when exposure to small spaces)
  • Do not meet the fMRI criteria established by the MU-BIC (regarding metal implants, etc.)
  • Pregnant
  • Does not meeting the MU-Brain Imaging Center screening criteria
  • Have given blood (for the American Red Cross) in the past 6 months or plan to give blood in the following 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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

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: Macronutrient and Fiber Matched BEEF
The participants will consume the macronutrient and fiber matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef (Cargill, KS). Soy fiber (Nutritional Designs, NY) was added to the BEEF meal to match total final content between meals.The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
Other: Macronutrient and Fiber Matched BEEF
The participants will consume the macronutrient and fiber matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef (Cargill, KS). Soy fiber (Nutritional Designs, NY) was added to the BEEF meal to match total final content between meals.The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
Experimental: Macronutrient and Fiber Matched SOY
The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day. SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).
Other: Macronutrient and Fiber Matched SOY
The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day. SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).
Experimental: Serving Size Matched BEEF
The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
Other: Serving Size Matched BEEF
The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
Experimental: Serving Size Matched SOY
The participants will consume the serving size matched SOY lunch on a single testing day. SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
Other: Serving Size Matched SOY
The participants will consume the serving size matched SOY lunch on a single testing day. SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).

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
Eating Initiation
Time Frame: 1 Day
Eating initiation will be measured as the time lapse between consuming the intervention and requesting dinner.
1 Day
Subsequent Food Intake
Time Frame: 1 Day
Ad libitum dinner and snacks were provided. Energy content and macronutrient content of these eating occasions were assessed.
1 Day
Net Incremental Area Under the Curve (niAUC) of Perceived Hunger and Fullness
Time Frame: - 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min
Computerized questionnaires, assessing perceived sensations of hunger and fullness were completed throughout the testing days. The questions are worded as "how strong is your feeling of" with anchors of "not at all" to "extremely." Each reported score can be a minimum of 0 and a maximum of 100 mm. niAUC was calculated for by computing the summation of the average change from baseline score (units of mm) for each time point and the subsequent time point, multiplied by the difference in time (min) between the two measures. For reported feelings of hunger, a higher score can be interpreted as "feeling more hungry." For fullness, higher can be interpreted as "feeling more full." Questionnaires were asked at baseline and about every 30 minutes throughout the day for a total of 20 questionnaires.
- 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min
Net Incremental Area Under the Curve (niAUC) of Plasma Total Glucagon-like Peptide (GLP-1) and Total Peptide YY (PYY)
Time Frame: - 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min
The samples were collected in test tubes containing ethylenediaminetetraacetic acid. Protease inhibitors (pefabloc SC and dipeptidyl peptidase) were added to some of the tubes to reduce protein degradation. The plasma was separated and stored at -80°C. Plasma total glucagon-like peptide (GLP-1) and peptide YY (PYY) were measured for all time points using the Milliplex multi-analyte profiling magnetic bead-based multi-analyte, metabolic panel, 2-plex assay and Magpix Luminex technologies. niAUC was calculated throughout the testing period by computing the summation of the average change from baseline score (units of pg/ml) for each time point and the subsequent time point, multiplied by the difference in time (units of min) between the two time instances for a total of 20 blood samples.
- 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min
Food Cue-stimulate fMRI Brain Scans
Time Frame: 3 hours
Participants viewed 3 categories of pictures including food, nonfood (animals), and blurred baseline images. The pictures from each category were presented in blocks of images. Animal pictures were used to control for visual richness and general interest (i.e., appealing but not appetizing). To determine the effects of protein type on neural activity associated with food motivation, repeated measures ANOVAs were performed on the brain activation maps within the Brain Voyager software with use of stimulus [food (i.e., appetizing and appealing) vs. nonfood (i.e., animal, nonappetizing but appealing] and protein source (BEEF vs. SOY) comparisons within the macronutrient and fiber-matched condition and the serving size-matched conditions, separately. The mean percent signal change in the maximum voxel within each region that displayed significant activation after the BEEF and SOY meals was then determined. Talairach coordinates for each region are presented for each row as (x;y;z).
3 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
Plasma Amino Acids
Time Frame: - 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min
Plasma amino acid concentrations were measured from the pre and hourly postprandial time points until dinner request following the Macronutrient and Fiber Matched BEEF meal and the Serving Size Matched Beef Meal. An average amino acid concentration was then determined from the change from baseline concentration for all available time points. Plasma amino acid analyses were performed through the University of Missouri-Columbia Agricultural Experiment Station Chemical Laboratories using cation-exchange chromatography (cIEC-HPLC) coupled with post-column ninhydrin derivatization and quantitation.
- 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min

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 Missouri-Columbia

Publications and helpful links

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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.
May 1, 2012

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, 2013

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.
March 1, 2014

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).
October 24, 2014

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 4, 2014

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.
November 7, 2014

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 15, 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.
April 30, 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.
April 1, 2019

More Information

Terms related to this study

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.
  • UMissouri

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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