Clinical trial NCT02285907: Protein Quality on Appetite Control, Reward-driven Eating, & Subsequent Food Intake
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite and General Nutritional Disorders
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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 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

Primary outcomes:
measure: Eating Initiation
timeFrame: 1 Day
measure: Subsequent Food Intake
timeFrame: 1 Day
measure: Net Incremental Area Under the Curve (niAUC) of Perceived Hunger and Fullness
timeFrame: - 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
measure: Net Incremental Area Under the Curve (niAUC) of Plasma Total Glucagon-like Peptide (GLP-1) and Total Peptide YY (PYY)
timeFrame: - 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
measure: Food Cue-stimulate fMRI Brain Scans
timeFrame: 3 hours
Secondary outcomes:
measure: Plasma Amino Acids
timeFrame: - 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
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Heather J Leidy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.