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The Consumption of Beef on Appetite and Cognitive Function

Primary Purpose

Obesity, Poor Glycemic Control, Dietary Interventions

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
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)
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring High Protein, Satiety, Appetite Control, Protein Distribution, Cognitive Function, Ad libitum Food Intake, Obesity prevention, Obesity treatment

Eligibility Criteria

18 Years - 52 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Energy Balance Comparison

    Energy Restriction Comparison

    Arm Description

    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)

    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)

    Outcomes

    Primary Outcome Measures

    Daily Energy Intake: Total Daily Intake
    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

    Perceived Fullness
    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.
    Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test
    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.
    Perceived Alertness
    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.
    Perceived Hunger
    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.
    Perceived Prospective Food Consumption
    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.
    Perceived Desire to Eat
    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.

    Full Information

    First Posted
    November 23, 2015
    Last Updated
    April 30, 2019
    Sponsor
    University of Missouri-Columbia
    Collaborators
    National Cattlemen's Beef Association
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02614729
    Brief Title
    The Consumption of Beef on Appetite and Cognitive Function
    Official Title
    A Randomized Controlled Feeding, Crossover Trial to Assess the Appetitive and Cognitive Effects of Daily Beef Consumption in Healthy, Overweight Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Missouri-Columbia
    Collaborators
    National Cattlemen's Beef Association

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Poor Glycemic Control, Dietary Interventions
    Keywords
    High Protein, Satiety, Appetite Control, Protein Distribution, Cognitive Function, Ad libitum Food Intake, Obesity prevention, Obesity treatment

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Energy Balance Comparison
    Arm Type
    Experimental
    Arm Description
    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)
    Arm Title
    Energy Restriction Comparison
    Arm Type
    Experimental
    Arm Description
    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)
    Intervention Type
    Other
    Intervention Name(s)
    Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN)
    Intervention Description
    Diet contains all plant proteins. Meals are evenly distributed throughout the day.
    Intervention Type
    Other
    Intervention Name(s)
    Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN)
    Intervention Description
    Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
    Intervention Type
    Other
    Intervention Name(s)
    High Protein-Beef, Even Distribution (HP-BEEF-EVEN)
    Intervention Description
    Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
    Intervention Type
    Other
    Intervention Name(s)
    High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)
    Intervention Description
    Diet contains combination of beef and plant proteins. Meals are unevenly distributed throughout the day.
    Primary Outcome Measure Information:
    Title
    Daily Energy Intake: Total Daily Intake
    Description
    Energy intake during breakfast, lunch, dinner, and evening snacks of each day 7 testing day (separated by 3-4 weeks) will be measured.
    Time Frame
    5 months
    Secondary Outcome Measure Information:
    Title
    Perceived Fullness
    Description
    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.
    Time Frame
    5 months
    Title
    Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test
    Description
    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.
    Time Frame
    5 months
    Title
    Perceived Alertness
    Description
    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.
    Time Frame
    5 months
    Title
    Perceived Hunger
    Description
    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.
    Time Frame
    5 months
    Title
    Perceived Prospective Food Consumption
    Description
    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.
    Time Frame
    5 months
    Title
    Perceived Desire to Eat
    Description
    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.
    Time Frame
    5 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    52 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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 <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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Heather J Leidy, PhD
    Organizational Affiliation
    University of Missouri-Columbia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    25926512
    Citation
    Leidy HJ, Clifton PM, Astrup A, Wycherley TP, Westerterp-Plantenga MS, Luscombe-Marsh ND, Woods SC, Mattes RD. The role of protein in weight loss and maintenance. Am J Clin Nutr. 2015 Jun;101(6):1320S-1329S. doi: 10.3945/ajcn.114.084038. Epub 2015 Apr 29.
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    Leidy HJ, Carnell NS, Mattes RD, Campbell WW. Higher protein intake preserves lean mass and satiety with weight loss in pre-obese and obese women. Obesity (Silver Spring). 2007 Feb;15(2):421-9. doi: 10.1038/oby.2007.531.
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