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| Name | Class |
|---|---|
| National Cattlemen's Beef Association, a contractor to the Beef Checkoff | INDUSTRY |
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The goal of this clinical trial is to learn if eating more beef will lead to better cognition and a healthier brain in younger adults. The main questions it aims to answer are:
Researchers will compare participants in the experimental group (participants who will eat 25 ounces of beef every week during the dietary intervention) to control participants (participants who will eat 5 ounces of beef every week during the dietary intervention).
Participants will:
The goal of this study is to evaluate the effects of beef consumption on cognitive and brain health in healthy younger adults. Specifically, we seek to evaluate the effects of beef consumption on measures of executive function, memory, psychological well-being, and sleep quality. Additionally, we will explore the effects of increased beef consumption on measures of brain health derived from structural and functional brain imaging.
The study will consist of two groups of participants: experimental and control. Participants from both groups will take part in a 12-week dietary intervention. Throughout the intervention, participants in the experimental group will receive 5 portions of ready-to-eat lean beef in frozen packages every week; and consume 5 portions per week. Each serving of ready-to-eat beef for the experimental group will weigh 5-ounces. Participants in the control group will also receive 5 portions of ready-to-eat lean beef in frozen packages every week; and consume 5 portions per week. Each serving of ready-to-eat beef for the control group will weigh 1-ounce. Study compliance will be evaluated through weekly surveys about beef consumption.
In addition, all participants will complete pre- and post-intervention assessments:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | The experimental group will participate in the 12-week beef dietary intervention study. Participants will be provided with 5 portions of ready-to-eat beef in frozen packages per week, and consume 5 portions per week. Each portion of beef provided to this group will weigh 5 ounces. |
|
| Control Group | Placebo Comparator | The control group will participate in the 12-week beef dietary intervention. Participants will be provided with 5 portions of ready-to-eat beef in frozen packages per week, and consume 5 portions per week. Each portion of beef provided to this group will weigh 1 ounce. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ready-to-eat beef in frozen, 5-oz packages | Dietary Supplement | The dietary intervention lasts 12 weeks for each individual. Participants in the experimental group will receive this intervention. Each participant will acquire 5 portions of ready-to eat beef in frozen packages per week, and consume 5 portions per week (1 portion of sirloin cap steak strips, 1 portion of shredded chuck roast, 1 portion of petite shoulder medallions, and 2 portions of ground beef crumbles); each portion of ready-to-eat beef in this intervention will weigh 5 ounces. |
| Measure | Description | Time Frame |
|---|---|---|
| WAIS-V | Wechsler Adult Intelligence Scale, verison 5. Comprehensive assessment battery for measuring cognitive abilities | Baseline and after 12 weeks |
| NIH Toolbox (Dimensional Change Card Sort) | Test for executive function and cognitive flexibility | Baseline and after 12 weeks |
| NIH Toolbox (Flanker) | test for executive functions: attention and inhibitory control | Baseline and after 12 weeks |
| NIH Toolbox (List Sorting Working Memory Test) | Test for working memory | Baseline and after 12 weeks |
| Cognitive Reflection Test | Test to measure the ability to suppress an intuitive wrong answer in favor of a more reflective correct answer | Baseline and after 12 weeks |
| Short Form-36 Health Survey | self-report measure of health status and quality of life | Baseline and after 12 weeks |
| Decision Outcome Inventory | an assessment of outcomes of real-life decisions | Baseline and after 12 weeks |
| Pittsburgh Sleep Quality Index | Self-report assessment of sleep quality over the past month. The survey includes measures related to Sleep Latency, Sleep Duration, Sleep Efficiency, Sleep Disturbances, Use of Sleep Medications, Daytime Fatigue, and Sleep Quality |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Imaging |
| Baseline and after 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Height | measured in feet and inches | Baseline and after 12 weeks |
| Weight | measured in pounds (lbs) | Baseline and after 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Douglas Schultz, PhD | Contact | 402-472-1843 | dschultz14@unl.edu | |
| Aron Barbey, PhD | Contact | 402-472-0168 | abarbey2@unl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Aron Barbey, PhD | University of Nebraska Lincoln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska-Lincoln | Recruiting | Lincoln | Nebraska | 68588 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32456281 | Background | Zhang H, Hardie L, Bawajeeh AO, Cade J. Meat Consumption, Cognitive Function and Disorders: A Systematic Review with Narrative Synthesis and Meta-Analysis. Nutrients. 2020 May 24;12(5):1528. doi: 10.3390/nu12051528. | |
| 34083695 | Background | Hepsomali P, Groeger JA. Diet and general cognitive ability in the UK Biobank dataset. Sci Rep. 2021 Jun 3;11(1):11786. doi: 10.1038/s41598-021-91259-3. |
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Study findings will be submitted to peer-reviewed journals such as those that follow the ICMJE's recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals. The data collected in this project may be shared through public-use files, repositories or other means outside of the approved research team as a requirement of publication. All data will be identified with subject IDs only when shared. Research records such as informed consent forms, MRI Safety Screening forms, research compliance records, masterlist linking names to subject IDs will not be shared.
IPD and supporting information will be available beginning 1 year after the publication of results with no end date.
Researchers who provide a methodologically sound proposal will be able to access the IPD and supporting information. Researchers are not restricted on the type of analyses, as long as they are methodologically sound. The statistical methods for those analyses must be approved before the researchers can gain access to the data.
For data sharing, a proposal that describes planned analyses must be submitted to the study's contact personnel for review. A data sharing agreement must be signed between the institution of the requesting researchers and the institution of the study's principal investigator.
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|
| Ready-to-eat beef in frozen, 1-oz packages | Dietary Supplement | The dietary intervention lasts 12 weeks for each individual. Participants in the control group will receive this intervention. Each participant will acquire 5 portions of ready-to eat beef in frozen packages per week, and consume 5 portions per week (1 portion of sirloin cap steak strips, 1 portion of shredded chuck roast, 1 portion of petite shoulder medallions, and 2 portions of ground beef crumbles); each portion of ready-to-eat beef in this intervention will weigh 1 ounce. |
|
| Baseline and after 12 weeks |
| Symptom Checklist 90-Revised | self-report assessment of psychological symptoms related to the domains of somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism | Baseline and after 12 weeks |
| Body Mass Index | Calculated by body mass divided by the square of the body height, unit in kg/m^2 | Baseline and after 12 weeks |
| Heart Rate | Heart rate will be reported as beats per minute. | Baseline and after 12 weeks |
| Systolic and Diastolic Blood Pressure | Measured in mmHg | Baseline and after 12 weeks |
| Body Composition | Body composition will be measured in body fat% | Baseline and after 12 weeks |
| Grip Strength | Participants will squeeze a hydraulic device three times with their right hand. Grip strength will be obtained by averaging the three measurements, which will be measured in kilograms. | Baseline and after 12 weeks |
| Blood-based biomarkers associated with consumption of beef | Biomarkers under evaluation include inflammatory biomarkers and nutrient biomarkers in blood from participants | Baseline and after 12 weeks |
| ID | Term |
|---|---|
| D005615 | Freezing |
| ID | Term |
|---|---|
| D044367 | Phase Transition |
| D055585 | Physical Phenomena |
| D003080 | Cold Temperature |
| D013696 | Temperature |
| D013816 | Thermodynamics |
| D055598 | Chemical Phenomena |
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