N/A
N=35
The Consumption of Beef on Appetite and Cognitive Function
Obesity · Poor Glycemic Control · Dietary Interventions
Bottom Line
View on ClinicalTrials.gov: NCT02614729 ↗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
| Outcome | Result | p-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
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.