The Consumption of Beef on Appetite and Cognitive Function

NCT02614729 | Completed Results

• 1 other identifier: 0039674
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Poor Glycemic Control; Dietary Interventions

Keywords

High Protein; Satiety; Appetite Control; Protein Distribution; Cognitive Function; Ad libitum Food Intake; Obesity prevention; Obesity treatment

Outcome Measures

Primary Outcomes (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.

  5 months

Secondary Outcomes (6)

• Perceived Fullness

  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 Prospective Food Consumption

  5 months

Study Arms (2)

Energy Balance Comparison

EXPERIMENTAL

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); 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 Comparison

EXPERIMENTAL

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); Other: Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); Other: High Protein-Beef, Even Distribution (HP-BEEF-EVEN)

Interventions

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

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

Energy Balance Comparison; Energy Restriction Comparison

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

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

Energy Balance Comparison; Energy Restriction Comparison

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

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

Energy Balance Comparison; Energy Restriction Comparison

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

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

Energy Balance Comparison

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• National Cattlemen's Beef Association, a contractor to the Beef Checkoff: collaborator

Related Publications (29)

• 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.

  PMID: 25926512 BACKGROUND

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  PMID: 7498104 BACKGROUND

• 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.

  PMID: 17299116 BACKGROUND

• 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.

  PMID: 12566476 BACKGROUND

• 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.

  PMID: 14988451 BACKGROUND

• 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.

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• 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.

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• 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.

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  PMID: 9920688 BACKGROUND

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  PMID: 19722288 BACKGROUND

• Paddon-Jones D, Leidy H. Dietary protein and muscle in older persons. Curr Opin Clin Nutr Metab Care. 2014 Jan;17(1):5-11. doi: 10.1097/MCO.0000000000000011.

  PMID: 24310053 BACKGROUND

• White MA, Whisenhunt BL, Williamson DA, Greenway FL, Netemeyer RG. Development and validation of the food-craving inventory. Obes Res. 2002 Feb;10(2):107-14. doi: 10.1038/oby.2002.17.

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  PMID: 17014981 BACKGROUND

• Leidy HJ, Tang M, Armstrong CL, Martin CB, Campbell WW. The effects of consuming frequent, higher protein meals on appetite and satiety during weight loss in overweight/obese men. Obesity (Silver Spring). 2011 Apr;19(4):818-24. doi: 10.1038/oby.2010.203. Epub 2010 Sep 16.

  PMID: 20847729 BACKGROUND

• Leidy HJ, Armstrong CL, Tang M, Mattes RD, Campbell WW. The influence of higher protein intake and greater eating frequency on appetite control in overweight and obese men. Obesity (Silver Spring). 2010 Sep;18(9):1725-32. doi: 10.1038/oby.2010.45. Epub 2010 Mar 25.

  PMID: 20339363 BACKGROUND

• Weigle DS, Breen PA, Matthys CC, Callahan HS, Meeuws KE, Burden VR, Purnell JQ. A high-protein diet induces sustained reductions in appetite, ad libitum caloric intake, and body weight despite compensatory changes in diurnal plasma leptin and ghrelin concentrations. Am J Clin Nutr. 2005 Jul;82(1):41-8. doi: 10.1093/ajcn.82.1.41.

  PMID: 16002798 BACKGROUND

• Leidy HJ, Todd CB, Zino AZ, Immel JE, Mukherjea R, Shafer RS, Ortinau LC, Braun M. Consuming High-Protein Soy Snacks Affects Appetite Control, Satiety, and Diet Quality in Young People and Influences Select Aspects of Mood and Cognition. J Nutr. 2015 Jul;145(7):1614-22. doi: 10.3945/jn.115.212092. Epub 2015 May 20.

  PMID: 25995282 BACKGROUND

• 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

  BACKGROUND

• Russell JA. Affect Grid: A single-item scale of pleasure and arousal. J Personality Soc Psychol 57 (3): 493-502, 1989.

  BACKGROUND

• Piacquadio KA, Gwin JA, Leidy HJ. A Higher-Protein, Energy Restriction Diet Containing 4 Servings of Fresh, Lean Beef per Day Does Not Negatively Influence Circulating miRNAs Associated with Cardiometabolic Disease Risk in Women with Overweight. Curr Dev Nutr. 2024 Aug 18;8(9):104442. doi: 10.1016/j.cdnut.2024.104442. eCollection 2024 Sep.

  PMID: 39310667 DERIVED

• Braden ML, Gwin JA, Leidy HJ. A Diet Containing Animal Source Protein as Fresh, Lean Beef Is More Well Liked and Promotes Healthier Eating Behavior Compared with Plant-Based Alternatives in Women with Overweight. Curr Dev Nutr. 2024 Jul 14;8(8):104415. doi: 10.1016/j.cdnut.2024.104415. eCollection 2024 Aug.

  PMID: 39224138 DERIVED

• Piacquadio KA, Margolis LM, Gwin JA, Leidy HJ. Higher Expression of miR-15b-5p with Inclusion of Fresh, Lean Beef as Part of a Healthy Dietary Pattern Is Inversely Associated with Markers of Cardiometabolic Disease Risk. J Nutr. 2024 Jun;154(6):1758-1765. doi: 10.1016/j.tjnut.2024.04.026. Epub 2024 Apr 25.

  PMID: 38677478 DERIVED

• Gwin JA, Maki KC, Alwattar AY, Leidy HJ. Examination of Protein Quantity and Protein Distribution across the Day on Ad Libitum Carbohydrate and Fat Intake in Overweight Women. Curr Dev Nutr. 2017 Oct 25;1(12):e001933. doi: 10.3945/cdn.117.001933. eCollection 2017 Dec.

  PMID: 29955692 DERIVED

• Gwin JA, Maki KC, Leidy HJ. Increased Protein Consumption during the Day from an Energy-Restricted Diet Augments Satiety but Does Not Reduce Daily Fat or Carbohydrate Intake on a Free-Living Test Day in Overweight Women. J Nutr. 2017 Dec;147(12):2338-2346. doi: 10.3945/jn.117.255554. Epub 2017 Oct 25.

  PMID: 29070709 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Heather Leidy
• Organization: Purdue University

hleidy@purdue.edu

765-496-0184

Study Officials

• Heather J Leidy, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: November 25, 2015
• Study Start: January 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 8, 2019
• Results First Posted: July 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share