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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Adults | Experimental | Adults with normal BMI (18.5 -24.9 kg/m2) and optimal/near optimal LDL-C (≤ 129 mg/dL). |
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| Adults at risk for cardiometabolic diseases | Experimental | Adults with overweight/obesity (25-39.9 kg/m2) and elevated LDL-C (130-190 mg/dL |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full-fat dairy | Other | 3 cup-equivalents/day of full-fat dairy (milk, yogurt & cheese) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Apolipoprotein B change | Assessed from fasting blood draw expressed in mg/dL. | 6 weeks |
| Triglycerides change | Assessed from fasting blood draw expressed in mg/dL. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristina Petersen, PhD | Contact | 814-865-7206 | kup63@psu.edu | |
| Stacey Meily | Contact | 814-863-8622 | sas117@psu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kristina Petersen, PhD | The Pennsylvania State University | Principal Investigator |
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Study protocol and SAP will be uploaded to clinicaltrials.gov prior to enrollment of the first participant
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Low-fat dairy | Other | 3 cup-equivalents/day of low-fat dairy (milk, yogurt & cheese) |
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| 6 weeks |
| Total cholesterol change | Assessed from fasting blood draw expressed in mg/dL. | 6 weeks |
| HDL-cholesterol change | Assessed from fasting blood draw expressed in mg/dL. | 6 weeks |
| non-HDL cholesterol change | Assessed from fasting blood draw expressed in mg/dL. | 6 weeks |
| Glucose change | Assessed from fasting blood draw expressed in mg/dL. | 6 weeks |
| Insulin change | Assessed from fasting blood draw expressed in micro IU/ml. | 6 weeks |
| Fructosamine change | Assessed from fasting blood draw expressed in umol/L. | 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 | 6 weeks |
| C-reactive protein change | Assessed from fasting blood draw expressed in mg/L. | 6 weeks |
| Body weight change | Measured in the fasting state using a calibrated electronic scale. | 6 weeks |
| Brachial systolic and diastolic blood pressure change | Measured in the fasting state using a SphymoCor Xcel (Atcor Medical) | 6 weeks |
| Central systolic and diastolic blood pressure change | Measured in the fasting state using a SphymoCor Xcel (Atcor Medical) | 6 weeks |
| Carotid-femoral pulse wave velocity change | Measured in the fasting state using a SphymoCor Xcel (Atcor Medical) | 6 weeks |
| Diet quality change | Healthy Eating Index-2020 assessed using 24-hour recalls | 6 weeks |