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N/A N=35 Randomized Single-blind Prevention

The Consumption of Beef on Appetite and Cognitive Function

Obesity · Poor Glycemic Control · Dietary Interventions

Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Daily Energy Intake: Total Daily Intake — 2859; 2313; 2714; 2396 kcal

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN) (Other); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN) (Other); High Protein-Beef, Even Distribution (HP-BEEF-EVEN) (Other); High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN) (Other)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
University of Missouri-Columbia
Primary completion
May 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Daily Energy Intake: Total Daily Intake
2859; 2313; 2714; 2396; 2830; 2820
SECONDARY
Perceived Fullness
38849; 32167; 38689; 30862; 39560; 36313
SECONDARY
Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test
309; 303; 321; 311; 320; 312
SECONDARY
Perceived Alertness
1631; 2151; 1525; 1950; 1374; 2434
SECONDARY
Perceived Hunger
16624; 21833; 17496; 24849; 16713; 18598
SECONDARY
Perceived Prospective Food Consumption
19158; 24889; 19847; 25929; 19087; 21015
SECONDARY
Perceived Desire to Eat
18132; 24309; 18753; 25886; 18179; 19921

Summary

The purpose of the main study is to determine whether the daily consumption of protein-rich meals containing high quality, lean beef products improves appetite control and cognitive function during a weight maintenance diet. The purpose of the sub-study is to determine whether the daily consumption of protein-rich meals containing the same amount of high quality, lean beef products improves appetite control and cognitive function during a modest energy restriction, weight loss diet.

Eligibility Criteria

Inclusion Criteria

  • Women
  • Ages: 18-52 y
  • BMI: 25-32 kg/m2
  • No metabolic, hormonal, and/or neural conditions/diseases that influence metabolism, appetite, or cognition
  • No blood donations to American Red Cross within past 6 months
  • No medication that would influence directly appetite or cognition
  • No change in any medications (over the past 3 months)
  • Non-smoking (for the past year)
  • Not pregnant within the past 6 months (or planning to become pregnant during study)
  • Have not given birth and/or lactating within the past 6 months
  • Normal menstrual cycles between 26-32 days in duration; 5 menstrual cycles within the past 6 months; or able to provide documentation of oral/hormonal contraceptive use which contains low-dose estrogen/progesterone to maintain continuous levels throughout the 28-day cycle (i.e., no placebos)
  • Not clinically diagnosed with an eating disorder
  • No weight loss/gain (≥10 lb. in the past 6 months)
  • No past history of surgical interventions for the treatment of obesity
  • No allergies and/or aversions to the study foods, particularly beef
  • Consumes ≤ 800 mg caffeine/day
  • Of this, ≤260 mg caffeine is consumed prior to lunch (~12 oz. Starbucks coffee)
  • Not currently and/or previously on a specific diet including high protein, vegan, vegetarian, etc.
  • Willing and able to consume all study foods
  • Habitually consumes breakfast, lunch, and dinner >4 days/week
  • No history of drug abuse or alcohol abuse (i.e., >14 drinks/week; 1 drink=12 oz. beer; 5 oz. wine; 1.5 oz. liquor)
  • Displays a score of 70 (>2%) on the CNS Vital Signs Battery
  • Sedentary (i.e., limited purposeful physical activity)
  • Willing and able to maintain current inactivity patterns throughout the study
  • Willing and able to follow all study procedures
  • Generally healthy, as assessed from the medical history questionnaire

Exclusion Criteria

  • Men
  • Ages: 52 y
  • BMI: 32 kg/m2
  • Any metabolic, hormonal, and/or neural conditions/diseases that influence metabolism, appetite, or cognition
  • Have donated blood to American Red Cross within past 6 months
  • Medication that would influence directly appetite or cognition
  • Change in medications (over the past 3 months)
  • Have smoked in the past year
  • Pregnant within the past 6 months (or planning to become pregnant during study)
  • Have given birth and/or lactating within the past 6 months
  • Abnormal menstrual cycles [not between 26-32 days in duration; or not 5-6 menstrual cycles within the past 6 months; or not able to provide documentation of oral/hormonal contraceptive use which contains low-dose estrogen/progesterone to maintain continuous levels throughout the 28-day cycle (i.e., no placebos)]
  • Clinically diagnosed with an eating disorder
  • Weight loss/gain (≥10 lb. in the past 6 months)
  • Past history of surgical interventions for the treatment of obesity
  • Allergies and/or aversions to the study foods, particularly beef
  • Consumes > 800 mg caffeine/day
  • Or, of caffeine consumed, >260 mg caffeine is consumed prior to lunch (~12 oz. Starbucks coffee)
  • Currently and/or previously on a specific diet including high protein, vegan, vegetarian, etc.
  • Unwilling and/or unable to consume all study foods
  • Habitually consumes breakfast, lunch, and dinner 14 drinks/week; 1 drink=12 oz. beer; 5 oz. wine; 1.5 oz. liquor)
  • Displays a score of >4 on the Three Factor Eating Habits Questionnaire (TFEQ)
  • Unconventional (atypical) and/or inconsistent sleep patterns
  • awake hours not somewhere between 5 am - 11 pm and/or afternoon naps
  • does not rate quality of sleep as Fairly to Very Good on the Pittsburg Sleep Quality Index (PSQI)
  • averages 70 (>2%) on the CNS Vital Signs Battery
  • Not sedentary (i.e., purposeful physical activity)
  • Unwilling and/or unable to maintain current inactivity patterns throughout the study
  • Unwilling and/or unable to follow all study procedures
  • Not generally healthy, as assessed from the medical history questionnaire
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02614729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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