Assessing the Influence of Habitual Beef Intake on Key Molecular Markers of Brain Health
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
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Samitinjaya Dhakal, PhD
- 電話番号:605-688-5465
- メール:samitinjaya.dhakal@sdstate.edu
研究場所
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South Dakota
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Brookings、South Dakota、アメリカ、57007
- 募集
- South Dakota State University
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コンタクト:
- Samitinjaya Dhakal
- 電話番号:605-688-5465
- メール:samitinjaya.dhakal@sdstate.edu
-
-
参加基準
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
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
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 |
|---|---|
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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.
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Participants will be provided with and instructed to consume 156 grams (5.5 ounces) of cooked lean beef daily for 14 days.
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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.
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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.
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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.
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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
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Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
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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.
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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.
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Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Shift in Plasma Lipidome Profile
時間枠:Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
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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.
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Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
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Change in Gut Microbiome Composition
時間枠:Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
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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.
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Baseline (Day 0) and End of Intervention (Day 14) for each of the two dietary phases.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB-2026-101
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
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
米国FDA規制機器製品の研究
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