- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07623785
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Samitinjaya Dhakal, PhD
- Número de telefone: 605-688-5465
- E-mail: samitinjaya.dhakal@sdstate.edu
Locais de estudo
-
-
South Dakota
-
Brookings, South Dakota, Estados Unidos, 57007
- Recrutamento
- South Dakota State University
-
Contato:
- Samitinjaya Dhakal
- Número de telefone: 605-688-5465
- E-mail: samitinjaya.dhakal@sdstate.edu
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Plasma Phosphorylated Tau-217 (p-tau217) Concentration
Prazo: 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
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Shift in Plasma Lipidome Profile
Prazo: 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
Prazo: 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.
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB-2026-101
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Lean Beef
-
Yale UniversityConcluídoObesidade | Sobrevivência ao Câncer de MamaEstados Unidos
-
University of Massachusetts, WorcesterNational Institute of Mental Health (NIMH)ConcluídoSuicídioEstados Unidos
-
University of Massachusetts, WorcesterNational Institute of Mental Health (NIMH)Concluído
-
University of AarhusInnovation Fund DenmarkConcluídoDiabetes tipo 2Dinamarca