A Randomized Controlled Feeding, Crossover Trial to Assess the Appetitive and Cognitive Effects of Daily Beef Consumption in Healthy, Overweight Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of Missouri-Columbia
- Enrollment
- 35
- Primary Endpoint
- Daily Energy Intake: Total Daily Intake
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed Description
Two cross-over design studies were completed in overweight, sedentary but otherwise healthy women. For study 1, 17 participants randomly consumed 4 eucaloric diets containing standard-protein (SP; 76±1g protein/d) or high-protein (HP; 126±1g protein/d) for 7 consecutive days/treatment. The SP treatments contained all plant proteins (PLANT) or a combination of beef and plant proteins (BEEF) that were evenly distributed throughout the day (EVEN). The HP treatments were also BEEF provided as EVEN or an uneven distribution (UNEVEN) pattern. For study 2, 17 participants randomly consumed 3 energy restriction (1250 kcal/d) diets containing SP-PLANT (EVEN) and SP-BEEF (EVEN) (both, 48±1g protein/d) or HP-BEEF (EVEN) (123±1g protein/d). During day 6 of each treatment (for both studies), the participants completed a 12-h controlled-feeding, clinical testing day which included repeated appetite, satiety, food cravings, and mood questionnaires; blood sampling; and cognitive function/performance testing. During day 7 of each treatment (for both studies), the participants completed a free-living, ad libitum testing day at home/work to assess ad libitum (voluntary) daily intake and food choice. Each of the 7-day dietary patterns occurred during the follicular phase of the menstrual cycle; thus, there were 2-3 week washout periods between dietary treatments.
Investigators
Heather Leidy
Assistant Professor
University of Missouri-Columbia
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •Ages: \<18 or \>52 y
- •BMI: \<25 or \>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 \[not between 26-32 days in duration; or not 5-6 menstrual cycles within the past 6 months; or not able to provide documentation of oral/hormonal contraceptive use which contains low-dose estrogen/progesterone to maintain continuous levels throughout the 28-day cycle (i.e., no placebos)\]
Outcomes
Primary Outcomes
Daily Energy Intake: Total Daily Intake
Time Frame: 5 months
Energy intake during breakfast, lunch, dinner, and evening snacks of each day 7 testing day (separated by 3-4 weeks) will be measured.
Secondary Outcomes
- Perceived Fullness(5 months)
- Perceived Prospective Food Consumption(5 months)
- Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test(5 months)
- Perceived Alertness(5 months)
- Perceived Hunger(5 months)
- Perceived Desire to Eat(5 months)