Investigating the Effects of Beef Consumption on Cognitive and Brain Health

Официальное название

Understanding the Cognitive and Brain Health Effects of Increasing Beef Consumption in Young Adults

Обзор

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: * Does eating more beef lead to higher scores on cognitive tests and better quality of life? * Does eating more beef lead to better brain function? 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: * Be instructed to prepare and consume ready-to-eat beef meals along with their regular diet and not eat any more beef other than what they are given * Visit the study facilities once every week to pick up ready-to-eat beef meals; and complete a brief survey every week to track their consumption of the provided beef meals, and a dietary survey every 4 weeks * Visit the study facilities before and after the 12-week of intervention period for researchers to study them

Подробное описание

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:

* MRI scan, including structural and functional brain imaging * a comprehensive questionnaire battery evaluating cognitive and psychological measures * neuropsychological tasks * a blood draw

Вмешательства

• Пищевая добавка Ready-to-eat beef in frozen, 5-oz packages
  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.
• Пищевая добавка Ready-to-eat beef in frozen, 1-oz packages
  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.

Первичные конечные точки

• WAIS-V [Срок оценки: Baseline and after 12 weeks]
• NIH Toolbox (Dimensional Change Card Sort) [Срок оценки: Baseline and after 12 weeks]
• NIH Toolbox (Flanker) [Срок оценки: Baseline and after 12 weeks]
• NIH Toolbox (List Sorting Working Memory Test) [Срок оценки: Baseline and after 12 weeks]
• Cognitive Reflection Test [Срок оценки: Baseline and after 12 weeks]
• Short Form-36 Health Survey [Срок оценки: Baseline and after 12 weeks]
• Decision Outcome Inventory [Срок оценки: Baseline and after 12 weeks]
• Pittsburgh Sleep Quality Index [Срок оценки: Baseline and after 12 weeks]
• Symptom Checklist 90-Revised [Срок оценки: Baseline and after 12 weeks]

Вторичные конечные точки (1)

• Brain Imaging [Срок оценки: Baseline and after 12 weeks]

Критерии участия

Критерии включения

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
• Males and females; Age 19-24
• Willingness to adhere to the ready-to-eat beef intervention regimen
• Lives within 75 miles of Lincoln, NE
• BMI between 18.5 and 39.9
• Not pregnant or nursing
• No history of cognitive or metabolic diseases indicated by diagnosis, including neurodegenerative disease, stroke, Type 1 and 2 diabetes, metabolic syndrome, cardiovascular disease, liver disease, kidney disease, and cancer
• No history of eating or anxiety disorders
• Willing to discontinue dietary supplement use throughout the duration of the study, if they are consuming supplement at the time of the registration
• No known contraindication to MRI scans as determined by the MRI screening survey questions

Критерии исключения

• Current use of medications that may affect their responses to dietary intervention, such as amphetamines, antidepressants, anti-diabetic medications, laxatives, antibiotics, statins and diuretics.
• Known intolerance or allergy to beef
• Current use of nicotine products, including vaping
• Previous use of nicotine products, including vaping, within the recent 6 months at the time of pre-screening

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of Nebraska-Lincoln — Lincoln

Публикации

• 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. PMID 32456281
• 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. PMID 34083695

Идентификаторы

NCT: NCT06690892 · 23404

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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