ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02285907
Recruitment Status : Completed
First Posted : November 7, 2014
Results First Posted : March 26, 2018
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Heather Leidy, University of Missouri-Columbia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Appetite and General Nutritional Disorders Other: Macronutrient and Fiber Matched BEEF Other: Macronutrient and Fiber Matched SOY Other: Serving Size Matched BEEF Other: Serving Size Matched SOY Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: The Effects of Consuming Beef vs. Soy-rich Lunch Meals, Matched for Macronutrient Content or Serving Size, on Markers of Appetite Control and Satiety
Study Start Date : May 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Eating Initiation [ Time Frame: 1 Day ]
    Eating initiation will be measured as the time lapse between consuming the intervention and requesting dinner.

  2. 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.

  3. Net Incremental Area Under the Curve (niAUC) of Perceived Hunger and Fullness [ Time Frame: 1 Day ]
    Computerized questionnaires, assessing perceived sensations of hunger and fullness were completed throughout the testing days. The questionnaires contained a visual analog scale incorporating a 100 mm horizontal line rating scale for each response. 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 perceived hunger and fullness 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 (units of min) between the two measures (also referred to as the trapezoidal rule). For reported feelings of hunger, a higher score can be interpreted as "feeling more hungry" throughout the day. For reported feelings of fullness, a higher can be interpreted as "feeling more full" throughout the day.

  4. Net Incremental Area Under the Curve (niAUC) of Plasma Total Glucagon-like Peptide (GLP-1) and Total Peptide YY (PYY) [ Time Frame: 1 Day ]
    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 in microcentrifuge tubes at -80°C for future analysis. 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 (Millipore, St. Charles, MO) and Magpix Luminex technologies (Luminex Corporation, Austin, TX). niAUC was calculated for perceived circulating GLP-1 and PYY 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 (also referred to as the trapezoidal rule).

  5. 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).


Secondary Outcome Measures :
  1. Plasma Amino Acids [ Time Frame: 1 day ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285907


Locations
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65211
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Heather J Leidy, PhD University of Missouri-Columbia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Heather Leidy, Assistant Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02285907     History of Changes
Other Study ID Numbers: UMissouri
First Posted: November 7, 2014    Key Record Dates
Results First Posted: March 26, 2018
Last Update Posted: March 26, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Nutrition Disorders