Cardiometabolic Effects of Low-Fat and Full-Fat Dairy
18 mei 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
178
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Kristina Petersen, PhD
- Telefoonnummer: 814-865-7206
- E-mail: kup63@psu.edu
Studie Contact Back-up
- Naam: Stacey Meily
- Telefoonnummer: 814-863-8622
- E-mail: sas117@psu.edu
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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)
|
|
Experimenteel: 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)
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
LDL-cholesterol change
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Apolipoprotein B change
Tijdsspanne: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Triglycerides change
Tijdsspanne: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Total cholesterol change
Tijdsspanne: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
HDL-cholesterol change
Tijdsspanne: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
non-HDL cholesterol change
Tijdsspanne: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Glucose change
Tijdsspanne: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Insulin change
Tijdsspanne: 6 weeks
|
Assessed from fasting blood draw expressed in micro IU/ml.
|
6 weeks
|
|
Fructosamine change
Tijdsspanne: 6 weeks
|
Assessed from fasting blood draw expressed in umol/L.
|
6 weeks
|
|
Homeostatic model of insulin resistance (HOMA-IR) change
Tijdsspanne: 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
Tijdsspanne: 6 weeks
|
Assessed from fasting blood draw expressed in mg/L.
|
6 weeks
|
|
Body weight change
Tijdsspanne: 6 weeks
|
Measured in the fasting state using a calibrated electronic scale.
|
6 weeks
|
|
Brachial systolic and diastolic blood pressure change
Tijdsspanne: 6 weeks
|
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
|
6 weeks
|
|
Central systolic and diastolic blood pressure change
Tijdsspanne: 6 weeks
|
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
|
6 weeks
|
|
Carotid-femoral pulse wave velocity change
Tijdsspanne: 6 weeks
|
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
|
6 weeks
|
|
Diet quality change
Tijdsspanne: 6 weeks
|
Healthy Eating Index-2020 assessed using 24-hour recalls
|
6 weeks
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Kristina Petersen, PhD, The Pennsylvania State University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
8 september 2026
Primaire voltooiing (Geschat)
31 augustus 2028
Studie voltooiing (Geschat)
31 augustus 2028
Studieregistratiedata
Eerst ingediend
18 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
18 mei 2026
Eerst geplaatst (Werkelijk)
26 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
26 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
18 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- DAIRY
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
IPD-tijdsbestek voor delen
Study protocol and SAP will be uploaded to clinicaltrials.gov
prior to enrollment of the first participant
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .