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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285907
First Posted: November 7, 2014
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
University of Missouri-Columbia
  Purpose
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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
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

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Eating Initiation [ Time Frame: 1 Day ]
    Eating initiation will be measured as the time of dinner request following the interventions

  • 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.

  • Appetite Assessment [ Time Frame: 1 Day ]
    Computerized questionnaires, assessing perceived sensations of hunger and fullness were completed throughout the testing days. A post-lunch palatability questionnaire was also completed to identify 'overall liking' of the meal. 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." The Adaptive Visual Analog Scale Software (Neurobehavioral Research Laboratory ad Clinic; San Antonio, TX) was used for these assessments.

  • Hormonal Responses [ Time Frame: 1 Day ]

    Blood samples (4 ml/sample; 64 ml/testing day) were collected every 30 min throughout the 8-h testing day. The samples were collected in test tubes containing ethylenediaminetetraacetic acid (EDTA) (ethylenediaminetetraacetic acid). Protease inhibitors (pefabloc SC and dipeptidyl peptidase (DPP-IV) were added to some of the tubes to reduce protein degradation (for the hormonal analyses). Within 10 min of collection, the samples were centrifuged at -4°C for 10 min. The plasma was separated and stored in microcentrifuge tubes at -80°C for future analysis.

    Plasma total glucagon-like peptide (GLP-1) and total peptide YY (PYY) were measured for all time points using the Milliplex multi-analyte profiling (MAP) magnetic bead-based multi-analyte, metabolic panel,2-plex assay (Millipore, St. Charles, MO) and Magpix Luminex technologies (Luminex Corporation, Austin, TX).


  • Food-cue Stimulated Functional Magnetic Resonance Imaging Brain Scans [ Time Frame: 1 Day ]
    A structural scan, lasting 10 min, was performed to identify anatomical structures. During the fMRI phase, the participants viewed photographs projected onto a screen. The fMRI paradigm incorporated 3 categories of pictures including food, animals, and blurred images. The pictures from each category were presented in blocks of images. Ten photographs (of the same type of stimuli) were presented per block. There were 3 repetitions of each block of stimulus-producing images(i.e., food, animal), alternated with blocks of randomized blurred images. Each photograph was projected for 2.5 sec, with an interstimulus interval of 0.5 sec. There was a total of 13 blocks of stimuli presented. The functional scan lasted approximately 7 min and was performed in duplicate. Scanning was performed at the University of Missouri Brain Imaging Center on a 3 Tesla Siemens Trio scanner (Siemens Medical Solutions, Erlangen, Germany).


Enrollment: 24
Study Start Date: May 2012
Study Completion Date: March 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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% carbohydrate (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.
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).

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.
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02285907     History of Changes
Other Study ID Numbers: UMissouri
First Submitted: October 24, 2014
First Posted: November 7, 2014
Last Update Posted: October 12, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Nutrition Disorders