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ObesityNCT02614729

The Consumption of Beef on Appetite and Cognitive Function

A study testing Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN), Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN) and High Protein-Beef, Even Distribution (HP-BEEF-EVEN) in people with Obesity and Poor Glycemic Control, run by University of Missouri-Columbia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 52 years, women onlyHealthy volunteers can take part
What is being tested?
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN), Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN) and High Protein-Beef, Even Distribution (HP-BEEF-EVEN)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
No sites listed yet
Study dates
Jan 2014to May 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 52 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 32Show fewer
  • 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

Who cannot join

  • 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
Show all 32Show fewer
  • 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

About this study

Official title: A Randomized Controlled Feeding, Crossover Trial to Assess the Appetitive and Cognitive Effects of Daily Beef Consumption in Healthy, Overweight Women

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.

Read the 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.

Being tested
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)
Keywords
High Protein, Satiety, Appetite Control, Protein Distribution, Cognitive Function, Ad libitum Food Intake, Obesity prevention, Obesity treatment
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN)Other

    Diet contains all plant proteins. Meals are evenly distributed throughout the day.

  • Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN)Other

    Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.

  • High Protein-Beef, Even Distribution (HP-BEEF-EVEN)Other

    Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.

  • High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)Other

    Diet contains combination of beef and plant proteins. Meals are unevenly distributed throughout the day.

Study groups in NCT02614729
Study groupRoleWhat they receive
Energy Balance ComparisonExperimentalParticipants 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)
Receives: 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)
Energy Restriction ComparisonExperimentalParticipants 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)
Receives: 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 months

Secondary outcomes (6)

  1. 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.

    Measured: 5 months

  2. 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.

    Measured: 5 months

  3. 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.

    Measured: 5 months

  4. 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.

    Measured: 5 months

  5. 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.

    Measured: 5 months

  6. 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.

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02614729
Sponsor's protocol ID
0039674
Status last verified
Apr 2019
First submitted
23 Nov 2015
Last updated
8 Jul 2019
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25926512

  • Holt SH, Miller JC, Petocz P, Farmakalidis E. A satiety index of common foods. Eur J Clin Nutr. 1995 Sep;49(9):675-90.

    PubMed 7498104

  • 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.

    PubMed 17299116

  • Layman DK, Boileau RA, Erickson DJ, Painter JE, Shiue H, Sather C, Christou DD. A reduced ratio of dietary carbohydrate to protein improves body composition and blood lipid profiles during weight loss in adult women. J Nutr. 2003 Feb;133(2):411-7. doi: 10.1093/jn/133.2.411.

    PubMed 12566476

  • Johnston CS, Tjonn SL, Swan PD. High-protein, low-fat diets are effective for weight loss and favorably alter biomarkers in healthy adults. J Nutr. 2004 Mar;134(3):586-91. doi: 10.1093/jn/134.3.586.

    PubMed 14988451

  • Mamerow MM, Mettler JA, English KL, Casperson SL, Arentson-Lantz E, Sheffield-Moore M, Layman DK, Paddon-Jones D. Dietary protein distribution positively influences 24-h muscle protein synthesis in healthy adults. J Nutr. 2014 Jun;144(6):876-80. doi: 10.3945/jn.113.185280. Epub 2014 Jan 29.

    PubMed 24477298

  • Leidy HJ, Bossingham MJ, Mattes RD, Campbell WW. Increased dietary protein consumed at breakfast leads to an initial and sustained feeling of fullness during energy restriction compared to other meal times. Br J Nutr. 2009 Mar;101(6):798-803. doi: 10.1017/s0007114508051532.

    PubMed 19283886

  • Hoyland A, Dye L, Lawton CL. A systematic review of the effect of breakfast on the cognitive performance of children and adolescents. Nutr Res Rev. 2009 Dec;22(2):220-43. doi: 10.1017/S0954422409990175.

    PubMed 19930787

  • Benau EM, Orloff NC, Janke EA, Serpell L, Timko CA. A systematic review of the effects of experimental fasting on cognition. Appetite. 2014 Jun;77:52-61. doi: 10.1016/j.appet.2014.02.014. Epub 2014 Feb 27.

    PubMed 24583414

  • Spring B, Maller O, Wurtman J, Digman L, Cozolino L. Effects of protein and carbohydrate meals on mood and performance: interactions with sex and age. J Psychiatr Res. 1982-1983;17(2):155-67. doi: 10.1016/0022-3956(82)90017-6.

    PubMed 6764932

  • Jakobsen LH, Kondrup J, Zellner M, Tetens I, Roth E. Effect of a high protein meat diet on muscle and cognitive functions: a randomised controlled dietary intervention trial in healthy men. Clin Nutr. 2011 Jun;30(3):303-11. doi: 10.1016/j.clnu.2010.12.010. Epub 2011 Jan 15.

    PubMed 21239090

  • Lieberman HR, Spring BJ, Garfield GS. The behavioral effects of food constituents: strategies used in studies of amino acids, protein, carbohydrate and caffeine. Nutr Rev. 1986 May;44 Suppl:61-70. doi: 10.1111/j.1753-4887.1986.tb07679.x. No abstract available.

    PubMed 2980858

  • Finnigan F, Hammersley R, Millar K. Effects of meal composition on blood alcohol level, psychomotor performance and subjective state after ingestion of alcohol. Appetite. 1998 Dec;31(3):361-75. doi: 10.1006/appe.1998.0168.

    PubMed 9920688

  • Nyenhuis DL, Yamamoto C, Luchetta T, Terrien A, Parmentier A. Adult and geriatric normative data and validation of the profile of mood states. J Clin Psychol. 1999 Jan;55(1):79-86. doi: 10.1002/(sici)1097-4679(199901)55:13.0.co;2-7.

    PubMed 10100834

  • Patterson K, Young C, Woods SP, Vigil O, Grant I, Atkinson JH; HIV Neurobehavioral Research Center Group. Screening for major depression in persons with HIV infection: the concurrent predictive validity of the Profile of Mood States Depression-Dejection Scale. Int J Methods Psychiatr Res. 2006 Jun;15(2):75-82. doi: 10.1002/mpr.184.

    PubMed 19722288

Questions about this trial

What is this clinical trial studying?

A study testing Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN), Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN) and High Protein-Beef, Even Distribution (HP-BEEF-EVEN) in people with Obesity and Poor Glycemic Control, run by University of Missouri-Columbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily Energy Intake: Total Daily Intake (time frame: 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02614729, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.

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