このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2026年5月28日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

20

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • South Dakota
      • Brookings、South Dakota、アメリカ、57007

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 高齢者

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:基礎科学
  • 割り当て:ランダム化
  • 介入モデル:クロスオーバー割り当て
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Plasma Phosphorylated Tau-217 (p-tau217) Concentration
時間枠: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
時間枠: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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Shift in Plasma Lipidome Profile
時間枠: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
時間枠: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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月3日

一次修了 (推定)

2026年8月30日

研究の完了 (推定)

2027年7月31日

試験登録日

最初に提出

2026年5月28日

QC基準を満たした最初の提出物

2026年5月28日

最初の投稿 (実際)

2026年6月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月3日

QC基準を満たした最後の更新が送信されました

2026年5月28日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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

IPD 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Lean Beefの臨床試験

購読する