Cardiometabolic Effects of Low-Fat and Full-Fat Dairy
18 de mayo de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
178
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Kristina Petersen, PhD
- Número de teléfono: 814-865-7206
- Correo electrónico: kup63@psu.edu
Copia de seguridad de contactos de estudio
- Nombre: Stacey Meily
- Número de teléfono: 814-863-8622
- Correo electrónico: sas117@psu.edu
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
LDL-cholesterol change
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Apolipoprotein B change
Periodo de tiempo: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Triglycerides change
Periodo de tiempo: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Total cholesterol change
Periodo de tiempo: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
HDL-cholesterol change
Periodo de tiempo: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
non-HDL cholesterol change
Periodo de tiempo: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Glucose change
Periodo de tiempo: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Insulin change
Periodo de tiempo: 6 weeks
|
Assessed from fasting blood draw expressed in micro IU/ml.
|
6 weeks
|
|
Fructosamine change
Periodo de tiempo: 6 weeks
|
Assessed from fasting blood draw expressed in umol/L.
|
6 weeks
|
|
Homeostatic model of insulin resistance (HOMA-IR) change
Periodo de tiempo: 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
Periodo de tiempo: 6 weeks
|
Assessed from fasting blood draw expressed in mg/L.
|
6 weeks
|
|
Body weight change
Periodo de tiempo: 6 weeks
|
Measured in the fasting state using a calibrated electronic scale.
|
6 weeks
|
|
Brachial systolic and diastolic blood pressure change
Periodo de tiempo: 6 weeks
|
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
|
6 weeks
|
|
Central systolic and diastolic blood pressure change
Periodo de tiempo: 6 weeks
|
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
|
6 weeks
|
|
Carotid-femoral pulse wave velocity change
Periodo de tiempo: 6 weeks
|
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
|
6 weeks
|
|
Diet quality change
Periodo de tiempo: 6 weeks
|
Healthy Eating Index-2020 assessed using 24-hour recalls
|
6 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Kristina Petersen, PhD, The Pennsylvania State University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
8 de septiembre de 2026
Finalización primaria (Estimado)
31 de agosto de 2028
Finalización del estudio (Estimado)
31 de agosto de 2028
Fechas de registro del estudio
Enviado por primera vez
18 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
18 de mayo de 2026
Publicado por primera vez (Actual)
26 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
18 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- DAIRY
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Marco de tiempo para compartir IPD
Study protocol and SAP will be uploaded to clinicaltrials.gov
prior to enrollment of the first participant
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .