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Cardiometabolic Effects of Low-Fat and Full-Fat Dairy

ConditionCardiovascular (CV) Risk
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-70
SponsorPenn State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Full-fat dairy

    Other intervention

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

  • Low-fat dairy

    Other intervention

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

Treatment groups

178 Participants
are divided into 2 treatment groups
Group A: Healthy AdultsExperimental treatment 2 interventions
Group B: Adults at risk for cardiometabolic diseasesExperimental treatment 2 interventions

Trial outcomes

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).

Time frame
6 weeks

Secondary outcomes

1

Apolipoprotein B change

Assessed from fasting blood draw expressed in mg/dL.

Time frame
6 weeks
2

Triglycerides change

Assessed from fasting blood draw expressed in mg/dL.

Time frame
6 weeks
3

Total cholesterol change

Assessed from fasting blood draw expressed in mg/dL.

Time frame
6 weeks
4

HDL-cholesterol change

Assessed from fasting blood draw expressed in mg/dL.

Time frame
6 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Penn State University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: