NCT07605442

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Sep 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 8, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 18, 2026

Last Update Submit

May 18, 2026

Conditions

Cardiovascular (CV) Risk

Keywords

dairydietnutritionLDL-cholesterolcardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • LDL-cholesterol change

    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

Secondary Outcomes (15)

  • Apolipoprotein B change

    6 weeks

  • Triglycerides change

    6 weeks

  • Total cholesterol change

    6 weeks

  • HDL-cholesterol change

    6 weeks

  • non-HDL cholesterol change

    6 weeks

  • +10 more secondary outcomes

Study Arms (2)

Healthy Adults

EXPERIMENTAL

Adults with normal BMI (18.5 -24.9 kg/m2) and optimal/near optimal LDL-C (≤ 129 mg/dL).

Other: Full-fat dairyOther: Low-fat dairy

Adults at risk for cardiometabolic diseases

EXPERIMENTAL

Adults with overweight/obesity (25-39.9 kg/m2) and elevated LDL-C (130-190 mg/dL

Other: Full-fat dairyOther: Low-fat dairy

Interventions

Full-fat dairyOTHER

3 cup-equivalents/day of full-fat dairy (milk, yogurt \& cheese)

Adults at risk for cardiometabolic diseasesHealthy Adults
Low-fat dairyOTHER

3 cup-equivalents/day of low-fat dairy (milk, yogurt \& cheese)

Adults at risk for cardiometabolic diseasesHealthy Adults

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Kristina Petersen, PhD

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Petersen, PhD

CONTACT

814-865-7206kup63@psu.edu

Stacey Meily

CONTACT

814-863-8622sas117@psu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 26, 2026

Study Start (Estimated)

September 8, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Study protocol and SAP will be uploaded to clinicaltrials.gov prior to enrollment of the first participant