Cardiovascular (CV) RiskNCT07605442
Cardiometabolic Effects of Low-Fat and Full-Fat Dairy
A study testing Full-fat dairy and Low-fat dairy in people with Cardiovascular (CV) Risk, run by Penn State University.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular (CV) Risk
- What is being tested?
- Full-fat dairy and Low-fat dairy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- No sites listed yet
- Study dates
- 8 Sep 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Cardiovascular (CV) Risk
- Being tested
- Full-fat dairy, Low-fat dairy
- Keywords
- dairy, diet, nutrition, LDL-cholesterol, cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-fat dairyOther
3 cup-equivalents/day of full-fat dairy (milk, yogurt \& cheese)
Low-fat dairyOther
3 cup-equivalents/day of low-fat dairy (milk, yogurt \& cheese)
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adults | Experimental | Adults with normal BMI (18.5 -24.9 kg/m2) and optimal/near optimal LDL-C (≤ 129 mg/dL). Receives: Other: Full-fat dairy; Other: 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 Receives: Other: Full-fat dairy; Other: Low-fat dairy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
Secondary outcomes (15)
Apolipoprotein B change
Assessed from fasting blood draw expressed in mg/dL.
Measured: 6 weeks
Triglycerides change
Assessed from fasting blood draw expressed in mg/dL.
Measured: 6 weeks
Total cholesterol change
Assessed from fasting blood draw expressed in mg/dL.
Measured: 6 weeks
HDL-cholesterol change
Assessed from fasting blood draw expressed in mg/dL.
Measured: 6 weeks
non-HDL cholesterol change
Assessed from fasting blood draw expressed in mg/dL.
Measured: 6 weeks
Glucose change
Assessed from fasting blood draw expressed in mg/dL.
Measured: 6 weeks
Insulin change
Assessed from fasting blood draw expressed in micro IU/ml.
Measured: 6 weeks
Fructosamine change
Assessed from fasting blood draw expressed in umol/L.
Measured: 6 weeks
Homeostatic model of insulin resistance (HOMA-IR) change
Calculated from insulin and glucose measured from a fasting blood sample. Calculated as (insulin × glucose) / 22.5
Measured: 6 weeks
C-reactive protein change
Assessed from fasting blood draw expressed in mg/L.
Measured: 6 weeks
Body weight change
Measured in the fasting state using a calibrated electronic scale.
Measured: 6 weeks
Brachial systolic and diastolic blood pressure change
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
Measured: 6 weeks
Central systolic and diastolic blood pressure change
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
Measured: 6 weeks
Carotid-femoral pulse wave velocity change
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
Measured: 6 weeks
Diet quality change
Healthy Eating Index-2020 assessed using 24-hour recalls
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start8 Sep 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular (CV) RiskStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Petersen PhD, APD, FAHA, Penn State University
- Investigators
- Kristina Petersen, PhD, Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605442
- Sponsor's protocol ID
- DAIRY
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Effects of Low-Fat and Full-Fat Dairy in Healthy and Cardiometabolically At-Risk Adults
- ClinicalTrials.gov ID
- NCT07605442
- Acronym / sponsor ID
- DAIRY
- Conditions
- Cardiovascular (CV) Risk
- Keywords
- dairy, diet, nutrition, LDL-cholesterol, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 8 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults | Experimental | Other: Full-fat dairy, Other: Low-fat dairyAdults with normal BMI (18.5 -24.9 kg/m2) and optimal/near optimal LDL-C (≤ 129 mg/dL). |
| Adults at risk for cardiometabolic diseases | Experimental | Other: Full-fat dairy, Other: Low-fat dairyAdults with overweight/obesity (25-39.9 kg/m2) and elevated LDL-C (130-190 mg/dL |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full-fat dairy3 cup-equivalents/day of full-fat dairy (milk, yogurt \& cheese) | Other | Adults at risk for cardiometabolic diseases, Healthy Adults |
| Low-fat dairy3 cup-equivalents/day of low-fat dairy (milk, yogurt \& cheese) | Other | Adults at risk for cardiometabolic diseases, Healthy Adults |
Primary outcome
LDL-cholesterol change
Time frame: 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).
15 secondary outcomes
Apolipoprotein B change
Time frame: 6 weeks
Triglycerides change
Time frame: 6 weeks
Total cholesterol change
Time frame: 6 weeks
HDL-cholesterol change
Time frame: 6 weeks
non-HDL cholesterol change
Time frame: 6 weeks
Glucose change
Time frame: 6 weeks
Insulin change
Time frame: 6 weeks
Fructosamine change
Time frame: 6 weeks
Homeostatic model of insulin resistance (HOMA-IR) change
Time frame: 6 weeks
C-reactive protein change
Time frame: 6 weeks
Body weight change
Time frame: 6 weeks
Brachial systolic and diastolic blood pressure change
Time frame: 6 weeks
Central systolic and diastolic blood pressure change
Time frame: 6 weeks
Carotid-femoral pulse wave velocity change
Time frame: 6 weeks
Diet quality change
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristina Petersen, PhD principal investigator
The Pennsylvania State University
Questions about this trial
What is this clinical trial studying?
A study testing Full-fat dairy and Low-fat dairy in people with Cardiovascular (CV) Risk, run by Penn State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristina Petersen, PhD (814-865-7206, kup63@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-cholesterol change (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.