NCT07401888 · Mayo Clinic
A Study Of Milk Consumption In Metabolic Syndrome
What this study is about
The primary purpose of this study is to determine the impact of whole-fat dairy consumption on cardiovascular and metabolic risk factors and peripheral vascular function in adults with metabolic syndrome.
View original scientific description
The primary purpose of this study is to determine the impact of whole-fat dairy consumption on cardiovascular and metabolic risk factors and peripheral vascular function in adults with metabolic syndrome.
Interventions
OTHER
Full-fat diet
The patients will follow a full-fat, isoenergetic diet consisting of 45% carbohydrates, 20% protein, and 35% fat for a duration of three weeks.
OTHER
Low-fat diet
The patients will follow a low-fat, isoenergetic diet consisting of 45% carbohydrates, 20% protein, and 35% fat for a duration of three weeks.
Primary outcome measures
Change in Total Cholesterol
Time frame: Baseline, Week 3, Week 5, Week 8
Total Cholesterol will be measured by a blood sample and reported as mg/dL
Change in HDL-C (High Density Lipoprotein Cholesterol)
Time frame: Baseline, Week 3, Week 5, Week 8
High Density Lipoprotein Cholesterol will be measured by a blood sample and reported as mg/dL
Change in LDL-C (Low Density Lipoprotein Cholesterol)
Time frame: Baseline, Week 3, Week 5, Week 8
Low Density Lipoprotein Cholesterol will be measured by a blood sample and reported as mg/dL
Change in Triglycerides
Time frame: Baseline, Week 3, Week 5, Week 8
Triglycerides will be measured by a blood sample and reported as mg/dL
Change in Blood Glucose
Time frame: Baseline, Week 3, Week 5, Week 8
Blood Glucose will be measured by a blood sample and reported as mg/dL
Change in Hemoglobin A1c
Time frame: Baseline, Week 3, Week 5, Week 8
Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin.
Change in C-reactive protein
Time frame: Baseline, Week 3, Week 5, Week 8
C-reactive protein will be measured by a blood sample and reported as mg/L
Change in Lipoprotein
Time frame: Baseline, Week 3, Week 5, Week 8
Lipoprotein will be measured by a blood sample and reported as mg/dL
Change in Macrovascular Function
Time frame: Baseline, Week 3, Week 5, Week 8
Peripheral macrovascular function is the maximal percent change in brachial artery following cuff release and will be assessed via flow-mediated dilation and reported as a percentage
Change in Microvascular Function
Time frame: Baseline, Week 3, Week 5, Week 8
Quantification of the area under the curve of the brachial artery blood flow following cuff release
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Presence of 3 of the following risk factors:
- fasting plasma glucose ≥100 mg/dL (or medical therapy for elevated glucose)
- HDL-C \<40 mg/dL in men or \<50 mg/dL in women (or medical therapy for reduced HDL-C)
- Triglycerides ≥150 mg/dL (or medical therapy for elevated triglycerides)
- Waist circumference \>102 cm for men and \>88 cm for women
- Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg (or medical therapy for hypertension)
Exclusion criteria
- Cardiovascular disease diagnosis
- Type 1 or 2 diabetes diagnosis
- Dairy allergy or lactose intolerance
- Self-reported high baseline dairy intake (\>3 servings per day)
- \>3 hours of physical activity per week
- Pregnant women
- Inflammatory bowel disease
- Chronic steroid use
- Allergy to metal
- GLP-1 agonist use
- Patients on medications related to metabolic syndrome where dose adjustments are planned to be made during the study period.
Where
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 16, 2026 · Source of record for eligibility and locations