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Assessing the Influence of Habitual Beef Intake on Key Molecular Markers of Brain Health

2026년 5월 28일 업데이트: Samitinjaya Dhakal, South Dakota State University

his study investigates whether eating lean beef every day can help support brain health and healthy aging in older adults. As people age, protecting memory and cognitive function becomes increasingly important. Lean beef is a rich source of essential nutrients-such as vitamin B12, iron, zinc, and creatine-that are known to support brain function. However, the direct biological effects of a beef-rich diet on brain health markers are not fully understood.

In this study, researchers will recruit 20 generally healthy older adults (aged 65 and older) to participate in a dietary feeding trial. Participants will complete two separate 2-week dietary phases. During one phase, participants will consume 5.5 ounces (156 grams) of provided lean beef daily. During the other phase, they will consume an iso-caloric, protein-matched, non-beef control food daily. A two-week "washout" period, where participants return to their normal diets, will separate the two phases to ensure there are no overlapping effects.

Researchers will collect blood, urine, stool, and saliva samples at the beginning and end of each 2-week dietary phase. These samples will be analyzed to see if the lean beef diet improves specific biological markers in the blood related to memory, nerve protection, and overall brain aging. Ultimately, the findings from this study will help determine if incorporating lean beef into a regular diet can be a natural, food-based strategy to help preserve neurological health in older adults.

연구 개요

상세 설명

Background and Rationale:

Cognitive decline and related dementias represent a growing public health crisis. While age and genetics are immutable risks, diet is a key modifiable factor for prevention and resilience. Lean beef provides a unique nutrient matrix-including vitamin B12, heme iron, zinc, selenium, creatine, and choline-that may support multiple aspects of brain structure and function. Recent advances in blood-based biomarkers now allow for the sensitive detection of neuropathological processes and neuroplasticity in response to lifestyle interventions. This project seeks to move beyond observational data to uncover the biological mechanisms that confer brain health by assessing the direct molecular impact of a dietary beef intervention.

Study Objectives:

The overarching goal of this study is to determine the impact of regular lean beef consumption on the molecular profile of brain health in healthy older adults. The primary aim is to quantify the within-person change in plasma phosphorylated tau-217 (p-tau217) following a 2-week lean beef intervention compared to a matched non-beef control. Secondary and exploratory aims include measuring within-person changes in the amyloid-beta 42/40 ratio (Aβ42/40) and Brain-Derived Neurotrophic Factor (BDNF), characterizing global shifts in the plasma lipidome, and exploring mechanisms of action via nutrient biomarkers.

Study Design:

The study is designed as a two-arm, randomized, controlled, crossover feeding trial. Twenty generally healthy adults (aged 65 years and older) will be block-randomized (1:1) to begin with either the intervention phase or the control phase.

Intervention Phase: Daily incorporation of 156 grams (5.5 oz) of lean beef for 14 days.

Control Phase: Daily incorporation of an iso-caloric, protein-matched non-beef control for 14 days.

A two-week washout period will separate the two phases to eliminate physiological carryover effects. Assignment of sequence will be randomized and counterbalanced to control for order and seasonal bias. Participants will maintain habitual eating patterns but will replace their daily protein sources with the study-provided food.

Methodology and Data Collection:

Clinical data and biological specimens will be collected at four distinct time points: the baseline and the conclusion of each 14-day dietary phase. At each clinical visit, fasted (12-hour) blood samples, as well as urine, stool, and saliva samples, will be collected. Basic anthropometric measurements, vital signs, and daily dietary records will also be obtained to monitor adherence and physical stability.

Outcome Evaluation and Analysis:

Targeted biomarkers of neurodegeneration and neuroplasticity (p-tau217, Aβ42/40, and BDNF) will be quantified using validated enzyme-linked immunosorbent assays (ELISA). Comprehensive untargeted lipidomic profiling will be conducted via Liquid Chromatography-Mass Spectrometry (LC-MS) workflows to identify lipid signatures associated with the intervention. Primary statistical analyses will utilize linear mixed-effects models to compare within-subject differences between the beef intervention and control conditions, adjusting for sequence and period effects. Appropriate statistical corrections will be applied for multiple comparisons and high-dimensional omics data.

연구 유형

중재적

등록 (추정된)

20

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • South Dakota
      • Brookings, South Dakota, 미국, 57007

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 고령자

건강한 자원 봉사자를 받아들입니다

설명

Inclusion Criteria:

Adults aged 65 years and older.

Generally healthy with no acute illnesses.

Fluent in English.

Willing to consume lean beef and dairy products (cottage cheese and whey protein) daily during the intervention phases.

Willing to maintain current, habitual diet, physical activity levels, and body weight throughout the study.

Willing to fast for 12 hours prior to clinical visits and provide blood, urine, stool, and saliva samples.

Exclusion Criteria:

Diagnosed with Alzheimer's disease, Parkinson's disease, or other severe cognitive disorders.

History of gastrointestinal diseases (e.g., Crohn's disease, celiac disease) or major gastrointestinal surgery.

Uncontrolled diabetes, severe liver or kidney disease, or a recent cardiovascular event (within the past 6 months).

Allergies or severe intolerances to beef or dairy, or adherence to a strict vegetarian or vegan diet.

Body weight fluctuation of >5% within the past 3 months.

Use of systemic antibiotics within the 2 months prior to baseline.

Current heavy smoking or excessive alcohol consumption.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Lean Beef Intervention
Participants will consume 156 grams (5.5 ounces) of provided lean beef daily for a 14-day period. Participants will be instructed to maintain their habitual dietary patterns otherwise, but will replace a portion of their standard daily protein intake with the study-provided lean beef.
Participants will be provided with and instructed to consume 156 grams (5.5 ounces) of cooked lean beef daily for 14 days.
활성 비교기: Non-Beef Control
Participants will consume a provided iso-caloric, protein-matched, non-beef control food daily for a 14-day period. Participants will be instructed to maintain their habitual dietary patterns otherwise, but will replace a portion of their standard daily protein intake with the study-provided control food.
Participants will be provided with and instructed to consume an iso-caloric, macronutrient- and protein-matched non-beef control consisting of a mixture of cottage cheese and whey protein daily for 14 days.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Plasma Phosphorylated Tau-217 (p-tau217) Concentration
기간: Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
Quantitative change in fasting plasma concentrations of p-tau217, a blood-based biomarker indicative of neurodegeneration and cognitive decline. This will be measured using commercially available Enzyme-Linked Immunosorbent Assays
Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
Change in Plasma Amyloid-Beta 42/40 (Aβ42/40) Ratio
기간: Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
Quantitative change in the ratio of fasting plasma Aβ42 to Aβ40, a recognized biomarker for early amyloid pathology. This will be measured using commercially available ELISA kits.
Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.

2차 결과 측정

결과 측정
측정값 설명
기간
Shift in Plasma Lipidome Profile
기간: Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
Global shifts in fasting plasma lipid species assessed via comprehensive untargeted lipidomics. Analysis will be conducted using Liquid Chromatography-Mass Spectrometry (LC-MS) workflows to evaluate relative abundance changes in lipid metabolites between the beef and control diets.
Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
Change in Gut Microbiome Composition
기간: Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
Alterations in gut microbial diversity and taxonomic relative abundance. This will be assessed via high-throughput sequencing (e.g., 16S rRNA or metagenomics) of DNA extracted from stool samples collected before and after each dietary phase.
Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 3일

기본 완료 (추정된)

2026년 8월 30일

연구 완료 (추정된)

2027년 7월 31일

연구 등록 날짜

최초 제출

2026년 5월 28일

QC 기준을 충족하는 최초 제출

2026년 5월 28일

처음 게시됨 (실제)

2026년 6월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 28일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

De-identified individual participant data (IPD) that underlie the results reported in the peer-reviewed published article will be made available to qualified researchers.

IPD 공유 기간

Data will become available immediately following the publication of the primary manuscript and will remain accessible for 5 years.

IPD 공유 액세스 기준

Data will be shared with qualified academic researchers who submit a methodologically sound proposal that has been approved by an independent review committee identified for this purpose. Proposals must be directed to the Principal Investigator. Data will only be shared for the purpose of achieving the aims explicitly outlined in the approved proposal, and a data-sharing agreement must be signed.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Lean Beef에 대한 임상 시험

구독하다