NCT02285907

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

March 26, 2018

Completed
Last Updated

May 15, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

October 24, 2014

Results QC Date

April 19, 2017

Last Update Submit

April 30, 2019

Conditions

Outcome Measures

Primary Outcomes (5)

  • Eating Initiation

    Eating initiation will be measured as the time lapse between consuming the intervention and requesting dinner.

    1 Day

  • Subsequent Food Intake

    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

    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)

    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

    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 Outcomes (1)

  • Plasma Amino Acids

    - 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

Study Arms (4)

Macronutrient and Fiber Matched BEEF

EXPERIMENTAL

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

Macronutrient and Fiber Matched SOY

EXPERIMENTAL

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

Serving Size Matched BEEF

EXPERIMENTAL

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

Serving Size Matched SOY

EXPERIMENTAL

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

Interventions

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).

Macronutrient and Fiber Matched BEEF

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).

Macronutrient and Fiber Matched SOY

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).

Serving Size Matched BEEF

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).

Serving Size Matched SOY

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

Related Publications (1)

  • Douglas SM, Lasley TR, Leidy HJ. Consuming Beef vs. Soy Protein Has Little Effect on Appetite, Satiety, and Food Intake in Healthy Adults. J Nutr. 2015 May;145(5):1010-6. doi: 10.3945/jn.114.206987. Epub 2015 Mar 25.

MeSH Terms

Interventions

Nutrients

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Dr. Heather Leidy
Organization
Purdue University

Study Officials

  • Heather J Leidy, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 24, 2014

First Posted

November 7, 2014

Study Start

May 1, 2012

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

May 15, 2019

Results First Posted

March 26, 2018

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations