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Cardiometabolic Effects of Low-Fat and Full-Fat Dairy

18 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

178

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Kristina Petersen, PhD
  • Numero di telefono: 814-865-7206
  • Email: kup63@psu.edu

Backup dei contatti dello studio

  • Nome: Stacey Meily
  • Numero di telefono: 814-863-8622
  • Email: sas117@psu.edu

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Healthy Adults
Adults with normal BMI (18.5 -24.9 kg/m2) and optimal/near optimal LDL-C (≤ 129 mg/dL).
Altro: Full-fat dairy
3 cup-equivalents/day of full-fat dairy (milk, yogurt & cheese)
Altro: Low-fat dairy
3 cup-equivalents/day of low-fat dairy (milk, yogurt & cheese)
Sperimentale: Adults at risk for cardiometabolic diseases
Adults with overweight/obesity (25-39.9 kg/m2) and elevated LDL-C (130-190 mg/dL
Altro: Full-fat dairy
3 cup-equivalents/day of full-fat dairy (milk, yogurt & cheese)
Altro: Low-fat dairy
3 cup-equivalents/day of low-fat dairy (milk, yogurt & cheese)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
LDL-cholesterol change
Lasso di tempo: 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

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Penn State University

Investigatori

  • Investigatore principale: Kristina Petersen, PhD, The Pennsylvania State University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

8 settembre 2026

Completamento primario (Stimato)

31 agosto 2028

Completamento dello studio (Stimato)

31 agosto 2028

Date di iscrizione allo studio

Primo inviato

18 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 maggio 2026

Primo Inserito (Effettivo)

26 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • DAIRY

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Periodo di condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

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Sedi

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