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Cardiometabolic Effects of Low-Fat and Full-Fat Dairy

18. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Detaljeret beskrivelse

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:

  1. 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.
  2. 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

178

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Kristina Petersen, PhD
  • Telefonnummer: 814-865-7206
  • E-mail: kup63@psu.edu

Undersøgelse Kontakt Backup

  • Navn: Stacey Meily
  • Telefonnummer: 814-863-8622
  • E-mail: sas117@psu.edu

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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)
Eksperimentel: 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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
LDL-cholesterol change
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Apolipoprotein B change
Tidsramme: 6 weeks
Assessed from fasting blood draw expressed in mg/dL.
6 weeks
Triglycerides change
Tidsramme: 6 weeks
Assessed from fasting blood draw expressed in mg/dL.
6 weeks
Total cholesterol change
Tidsramme: 6 weeks
Assessed from fasting blood draw expressed in mg/dL.
6 weeks
HDL-cholesterol change
Tidsramme: 6 weeks
Assessed from fasting blood draw expressed in mg/dL.
6 weeks
non-HDL cholesterol change
Tidsramme: 6 weeks
Assessed from fasting blood draw expressed in mg/dL.
6 weeks
Glucose change
Tidsramme: 6 weeks
Assessed from fasting blood draw expressed in mg/dL.
6 weeks
Insulin change
Tidsramme: 6 weeks
Assessed from fasting blood draw expressed in micro IU/ml.
6 weeks
Fructosamine change
Tidsramme: 6 weeks
Assessed from fasting blood draw expressed in umol/L.
6 weeks
Homeostatic model of insulin resistance (HOMA-IR) change
Tidsramme: 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
Tidsramme: 6 weeks
Assessed from fasting blood draw expressed in mg/L.
6 weeks
Body weight change
Tidsramme: 6 weeks
Measured in the fasting state using a calibrated electronic scale.
6 weeks
Brachial systolic and diastolic blood pressure change
Tidsramme: 6 weeks
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
6 weeks
Central systolic and diastolic blood pressure change
Tidsramme: 6 weeks
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
6 weeks
Carotid-femoral pulse wave velocity change
Tidsramme: 6 weeks
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
6 weeks
Diet quality change
Tidsramme: 6 weeks
Healthy Eating Index-2020 assessed using 24-hour recalls
6 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Kristina Petersen, PhD, The Pennsylvania State University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

8. september 2026

Primær færdiggørelse (Anslået)

31. august 2028

Studieafslutning (Anslået)

31. august 2028

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DAIRY

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-delingstidsramme

Study protocol and SAP will be uploaded to clinicaltrials.gov prior to enrollment of the first participant

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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