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Trial record 1 of 2 for:    7498104 [PUBMED-IDS]
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The Consumption of Beef on Appetite and Cognitive Function

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ClinicalTrials.gov Identifier: NCT02614729
Recruitment Status : Completed
First Posted : November 25, 2015
Results First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
National Cattlemen's Beef Association
Information provided by (Responsible Party):
Heather Leidy, University of Missouri-Columbia

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.


Condition or disease Intervention/treatment Phase
Obesity Poor Glycemic Control Dietary Interventions Other: 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) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Feeding, Crossover Trial to Assess the Appetitive and Cognitive Effects of Daily Beef Consumption in Healthy, Overweight Women
Study Start Date : January 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Experimental: Energy Balance Comparison

Participants will randomly consume 4 eucaloric diets for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy balance.

Interventions:

Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN); High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)

Other: Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN)
Diet contains all plant proteins. Meals are evenly distributed throughout the day.

Other: Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN)
Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.

Other: High Protein-Beef, Even Distribution (HP-BEEF-EVEN)
Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.

Other: High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)
Diet contains combination of beef and plant proteins. Meals are unevenly distributed throughout the day.

Experimental: Energy Restriction Comparison

Participants will randomly consume 3 energy restriction diets (1250 kcal/day) for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy restriction.

Interventions:

Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN)

Other: Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN)
Diet contains all plant proteins. Meals are evenly distributed throughout the day.

Other: Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN)
Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.

Other: High Protein-Beef, Even Distribution (HP-BEEF-EVEN)
Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Perceived Fullness [ Time Frame: 5 months ]
    Questionnaires assessing fullness will be completed throughout each of the 12-hour testing days (which are separated by 3-4 weeks). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The scale is 0 to 100mm. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not at all" (indicated at 0 mm) to "extremely" (indicated at 100 mm). All measures are reported at area under the curve for 0 to 630 min.

  2. Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test [ Time Frame: 5 months ]
    Cognitive function will be assessed during each of the 12-hour testing days using CNS Vital Signs, a validated computerized assessment. This system contains a core battery of tasks. Reaction Time is the outcome of interest measured with the Stroop Test. In the first part, the words RED, YELLOW, BLUE, & GREEN (printed in black) appear at random on the screen, & the participant presses the space bar as soon as the test subject sees the word. In the second part, the words RED, YELLOW, BLUE, & GREEN appear on the screen, printed in color. The participant is asked to press the space bar when the color of the word matches what the word says. In the third part, the words RED, YELLOW, BLUE, & GREEN appear on the screen, printed in color. The participant is asked to press the space bar when the color of the word does not match what the word says. Reaction time is in milliseconds.

  3. Perceived Alertness [ Time Frame: 5 months ]
    Alertness will be assessed during each of the 12-hour testing days (which are separated by 3-4 weeks) using the Profile of Mood States 2nd Edition (POMS2) with sub-categories of perceived vigor. POM2 is a self-report measure that allows for the quick assessment of transient, fluctuating feelings, and enduring affect states. There are 35 items. Items are rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The Alertness (Vigor-Activity) scale score indicates the extent to which individual felt alert (vigorous and/or energetic); the higher are her positive feelings and/or energy, the greater is her score (i.e., a low score indicates relatively fewer positive feelings and/or low energy). Ratings on this scale yielded a T-score of 25 (95% CI =18-32), which is ranked at the 1st percentile, and falls within the Very Low score range. The T scores were then used to calculate area under the curve.

  4. Perceived Hunger [ Time Frame: 5 months ]
    Questionnaires assessing hunger will be completed throughout each of the 12-hour testing days (which are separated by 3-4 weeks). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The scale is 0 to 100mm. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not at all" (indicated at 0 mm) to "extremely" (indicated at 100 mm). All measures are reported at area under the curve for 0 to 630 min.

  5. Perceived Prospective Food Consumption [ Time Frame: 5 months ]
    Questionnaires assessing prospective food consumption will be completed throughout each of the 12-hour testing days (which are separated by 3-4 weeks). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The scale is 0 to 100mm. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not at all" (indicated at 0 mm) to "extremely" (indicated at 100 mm). All measures are reported at area under the curve for 0 to 630 min.

  6. Perceived Desire to Eat [ Time Frame: 5 months ]
    Questionnaires assessing desire to eat will be completed throughout each of the 12-hour testing days (which are separated by 3-4 weeks). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The scale is 0 to 100mm. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not at all" (indicated at 0 mm) to "extremely" (indicated at 100 mm). All measures are reported at area under the curve for 0 to 630 min.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 52 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 <4 on the Three Factor Eating Habits Questionnaire (TFEQ)
  • Conventional (typical) and consistent sleep patterns
  • awake hours somewhere between 5 am - 11 pm with no afternoon naps
  • rates quality of sleep as Fairly to Very Good on the Pittsburg Sleep Quality Index (PSQI)
  • averages ≥ 6 sleep hours/night over the past month
  • Displays a Profile of Mood State 2nd Edition (POMS2; 60-item) Depression-Dejection Scale score within 1.5 SD of the age, gender, and racial-specific normative mean (Nyenhuis et al., 1999; Petterson K et al., 2006)
  • Obtained a "Yes" on the validity indicator and displayed 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: <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)]
  • 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 <4 days/week
  • 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 >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 < 6 sleep hours/night over the past month
  • Does not display a Profile of Mood State 2nd Edition (POMS2; 60-item) Depression-Dejection Scale score within 1.5 SD of the age, gender, and racial-specific normative mean (Nyenhuis et al., 1999; Petterson K et al., 2006)
  • Did not obtain a "Yes" on the validity indicator and/or did not display a score of >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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614729


Sponsors and Collaborators
University of Missouri-Columbia
National Cattlemen's Beef Association
Investigators
Layout table for investigator information
Principal Investigator: Heather J Leidy, PhD University of Missouri-Columbia

Publications:
Zeng YC, Li SM, Xiong GL, Su HM, Wan JC. Influences of protein to energy ratios in breakfast on mood, alertness and attention in the healthy undergraduate students. Health 3(6): 383-393. 2011
Russell JA. Affect Grid: A single-item scale of pleasure and arousal. J Personality Soc Psychol 57 (3): 493-502, 1989.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Heather Leidy, Assistant Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02614729     History of Changes
Other Study ID Numbers: 0039674
First Posted: November 25, 2015    Key Record Dates
Results First Posted: July 8, 2019
Last Update Posted: July 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Heather Leidy, University of Missouri-Columbia:
High Protein
Satiety
Appetite Control
Protein Distribution
Cognitive Function
Ad libitum Food Intake
Obesity prevention
Obesity treatment

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms