Cardiometabolic Effects of Low-Fat and Full-Fat Dairy
18 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
178
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Kristina Petersen, PhD
- Numéro de téléphone: 814-865-7206
- E-mail: kup63@psu.edu
Sauvegarde des contacts de l'étude
- Nom: Stacey Meily
- Numéro de téléphone: 814-863-8622
- E-mail: sas117@psu.edu
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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)
|
|
Expérimental: 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)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
LDL-cholesterol change
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Apolipoprotein B change
Délai: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Triglycerides change
Délai: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Total cholesterol change
Délai: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
HDL-cholesterol change
Délai: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
non-HDL cholesterol change
Délai: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Glucose change
Délai: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Insulin change
Délai: 6 weeks
|
Assessed from fasting blood draw expressed in micro IU/ml.
|
6 weeks
|
|
Fructosamine change
Délai: 6 weeks
|
Assessed from fasting blood draw expressed in umol/L.
|
6 weeks
|
|
Homeostatic model of insulin resistance (HOMA-IR) change
Délai: 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
Délai: 6 weeks
|
Assessed from fasting blood draw expressed in mg/L.
|
6 weeks
|
|
Body weight change
Délai: 6 weeks
|
Measured in the fasting state using a calibrated electronic scale.
|
6 weeks
|
|
Brachial systolic and diastolic blood pressure change
Délai: 6 weeks
|
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
|
6 weeks
|
|
Central systolic and diastolic blood pressure change
Délai: 6 weeks
|
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
|
6 weeks
|
|
Carotid-femoral pulse wave velocity change
Délai: 6 weeks
|
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
|
6 weeks
|
|
Diet quality change
Délai: 6 weeks
|
Healthy Eating Index-2020 assessed using 24-hour recalls
|
6 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Kristina Petersen, PhD, The Pennsylvania State University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
8 septembre 2026
Achèvement primaire (Estimé)
31 août 2028
Achèvement de l'étude (Estimé)
31 août 2028
Dates d'inscription aux études
Première soumission
18 mai 2026
Première soumission répondant aux critères de contrôle qualité
18 mai 2026
Première publication (Réel)
26 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- DAIRY
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Délai de partage IPD
Study protocol and SAP will be uploaded to clinicaltrials.gov
prior to enrollment of the first participant
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .