Cardiometabolic Effects of Low-Fat and Full-Fat Dairy
18 de maio de 2026 atualizado por: Kristina Petersen PhD, APD, FAHA, Penn State University
Cardiometabolic Effects of Low-Fat and Full-Fat Dairy in Healthy and Cardiometabolically At-Risk Adults
The purpose of this study is to find out if full-fat dairy and low-fat dairy have similar effects on risk factors for heart disease and diabetes.
During the study, participants will consume two types of dairy products: low-fat dairy (milk, yogurt, and cheese) and full-fat dairy (milk, yogurt, and cheese).
Each type of dairy will be consumed for 6 weeks with a ≥4-week break between.
Measures will be taken to evaluate blood cholesterol, blood sugar, body weight, inflammation, blood pressure, heart health and dietary intake at the beginning and end of each 6 week period.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
The overarching goal of this clinical trial is to characterize and compare the effect of full-fat dairy to low-fat dairy on low density lipoprotein cholesterol (LDL-C) and other cardiometabolic disease (CMD) risk factors in healthy adults and those at risk for CMD. This goal will be achieved with the following objectives:
- Characterize the effect of full-fat dairy compared to low-fat dairy on LDL-C and other CMD risk factors in healthy adults and adults at risk for CMD after 6 weeks.
- Compare the effect of full-fat dairy to low-fat dairy in healthy adults vs. adults at risk for CMD after 6 weeks.
This clinical trial will test two hypotheses: 1) intake of 3 cup-equivalents/day of full-fat dairy (milk, yogurt & cheese) has equivalent effects on LDL-C and other CMD risk factors to 3 cup-equivalents/day of low-fat dairy (milk, yogurt & cheese) in adults with normal BMI and optimal/near optimal LDL-C, and in adults with overweight/obesity and elevated LDL-C after 6 weeks; 2) the effect of full-fat dairy on LDL-C and other CMD risk factors, compared to low-fat dairy, is equivalent in adults with normal BMI and optimal/near optimal LDL-C compared to adults with overweight/obesity and elevated LDL-C after 6 weeks. This trial is expected to demonstrate equivalent effects of full-fat and low-fat dairy on LDL-C and other CMD risk factors in both healthy and at-risk adults.
This is a randomized clinical trial with 2 groups of adults. Group 1 will include adults with normal BMI (18.5 -24.9 kg/m2) and optimal/near optimal LDL-C (≤ 129 mg/dL). Group 2 will include adults with overweight/obesity (25-39.9 kg/m2) and elevated LDL-C (130-190 mg/dL). Within each group, subjects will undergo two 6-week dietary conditions in random sequence order, separated by a 4-week washout: 1) 3 cup-equivalents/day of full-fat dairy; 2) 3 cup-equivalents/day of low-fat dairy. Outcomes will be assessed at the start and end of each period.
Tipo de estudo
Intervencional
Inscrição (Estimado)
178
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Kristina Petersen, PhD
- Número de telefone: 814-865-7206
- E-mail: kup63@psu.edu
Estude backup de contato
- Nome: Stacey Meily
- Número de telefone: 814-863-8622
- E-mail: sas117@psu.edu
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- BMI 18.5 to 39.9 kg/m2
- LDL-C ≤190 mg/dL assessed by the Modified Sampson-NIH Equation
- Currently consume milk, yogurt, and/or cheese daily
- Willing to eat 3 servings of dairy (milk, yogurt, cheese) for two 6-week periods during the study
Exclusion Criteria:
- Hemoglobin <13.2 g/dL for men or < 11.7 g/dL for women at screening
- Fasting triglycerides >350 mg/dL at screening
- ≥10% change in body weight within the 6 months prior to enrollment
- Blood pressure >140/90 mmHg at screening
- Fasting glucose ≥126 mg/dL
- Type 1 or type 2 diabetes
- Takes any (prescription or over-the-counter) anti-hypertensive, lipid-lowering, glucose-lowering or anti-inflammatory drugs, or drugs that alter body weight
- Intake of supplements that affect the outcomes of interest (i.e., lipids, blood pressure, glucose, body weight, inflammation and microbiome) and are unwilling to cease during the study period.
- Unwilling to refrain from starting to take any supplements, vitamins, nutritional products, or health foods that are not prescribed by a doctor for the duration of the study
- History of liver, kidney, or autoimmune disease
- Prior cardiovascular event (e.g., stroke, heart attack)
- Current pregnancy or intention of pregnancy within the next 12 months
- Lactation within the prior 6 months
- Dairy allergy/intolerance/sensitivity/dislike
- Antibiotic use within the prior four weeks
- Oral steroid use within the prior four weeks
- Use of tobacco or nicotine-containing products within the past 6 months
- History of cancer at any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer within the past 5 years (eligible if ≥5 years without recurrence)
- Participation in another clinical trial within 60 days of baseline
- Currently following a restricted or weight-loss diet
- Prior bariatric surgery
- Intake of >14 alcoholic drinks/week and/or not willing to avoid alcohol consumption for 48 hours prior to test visits
- Does not speak and/or understand English
- Unwilling to refrain from donating blood and/or plasma during the study
- Weight <110 lb
- Lactose intolerance or sensitivity
- Unwilling to contact study staff before enrolling in other health-related research and avoid participating in any research that may interfere with this study
- For individuals taking thyroid medication: abnormal thyroid stimulated hormone (TSH) concentration, or change in dose of thyroid medication within the last 6 months
- Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements, including being able to come to attend visits
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Healthy Adults
Adults with normal BMI (18.5 -24.9 kg/m2) and optimal/near optimal LDL-C (≤ 129 mg/dL).
|
3 cup-equivalents/day of full-fat dairy (milk, yogurt & cheese)
3 cup-equivalents/day of low-fat dairy (milk, yogurt & cheese)
|
|
Experimental: Adults at risk for cardiometabolic diseases
Adults with overweight/obesity (25-39.9
kg/m2) and elevated LDL-C (130-190 mg/dL
|
3 cup-equivalents/day of full-fat dairy (milk, yogurt & cheese)
3 cup-equivalents/day of low-fat dairy (milk, yogurt & cheese)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
LDL-cholesterol change
Prazo: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
LDL-cholesterol will be calculated via the Modified Sampson-NIH Equation.
Change in LDL-cholesterol will be calculated as the mean of the end of intervention measures (i.e., mean of day 1 and day 2 values) minus the mean of the pre-intervention measures (i.e., mean of day 1 and day 2 values).
|
6 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Apolipoprotein B change
Prazo: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Triglycerides change
Prazo: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Total cholesterol change
Prazo: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
HDL-cholesterol change
Prazo: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
non-HDL cholesterol change
Prazo: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Glucose change
Prazo: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Insulin change
Prazo: 6 weeks
|
Assessed from fasting blood draw expressed in micro IU/ml.
|
6 weeks
|
|
Fructosamine change
Prazo: 6 weeks
|
Assessed from fasting blood draw expressed in umol/L.
|
6 weeks
|
|
Homeostatic model of insulin resistance (HOMA-IR) change
Prazo: 6 weeks
|
Calculated from insulin and glucose measured from a fasting blood sample.
Calculated as (insulin × glucose) / 22.5
|
6 weeks
|
|
C-reactive protein change
Prazo: 6 weeks
|
Assessed from fasting blood draw expressed in mg/L.
|
6 weeks
|
|
Body weight change
Prazo: 6 weeks
|
Measured in the fasting state using a calibrated electronic scale.
|
6 weeks
|
|
Brachial systolic and diastolic blood pressure change
Prazo: 6 weeks
|
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
|
6 weeks
|
|
Central systolic and diastolic blood pressure change
Prazo: 6 weeks
|
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
|
6 weeks
|
|
Carotid-femoral pulse wave velocity change
Prazo: 6 weeks
|
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
|
6 weeks
|
|
Diet quality change
Prazo: 6 weeks
|
Healthy Eating Index-2020 assessed using 24-hour recalls
|
6 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Kristina Petersen, PhD, The Pennsylvania State University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
8 de setembro de 2026
Conclusão Primária (Estimado)
31 de agosto de 2028
Conclusão do estudo (Estimado)
31 de agosto de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
18 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de maio de 2026
Primeira postagem (Real)
26 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
26 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- DAIRY
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Prazo de Compartilhamento de IPD
Study protocol and SAP will be uploaded to clinicaltrials.gov
prior to enrollment of the first participant
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
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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 .