How whole-fat versus low-fat milk affects adults with metabolic syndrome
Official title: Milk Consumption On Cardiovascular Risk Factors In Metabolic Syndrome
Run by Mayo Clinic · NCT07401888 · Data updated 2026-11-12
This trial will test whether drinking whole-fat milk compared with low-fat milk changes heart and metabolic risk factors and blood vessel function in adults with metabolic syndrome.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | April 13, 2026 |
| Main results expected | February 2028 |
| Study ends | February 2028 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT07401888 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with metabolic syndrome (having at least three qualifying risk factors) who do not have diabetes or cardiovascular disease and do not already consume high amounts of dairy.
✕Probably not a fit
People with diagnosed diabetes or cardiovascular disease, dairy allergy or lactose intolerance, pregnant women, those already eating more than three dairy servings per day, or those on excluded medications are not eligible and would not gain benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults who meet diagnostic criteria for metabolic syndrome will be assigned to follow a diet emphasizing whole-fat dairy or a diet emphasizing low-fat dairy for the intervention period. Investigators will measure cardiovascular and metabolic risk markers (including fasting glucose, HDL, triglycerides, waist circumference, and blood pressure) and peripheral vascular function before and after the dietary intervention. Key exclusions include diagnosed diabetes, existing cardiovascular disease, dairy allergy or lactose intolerance, high baseline dairy intake, pregnancy, and certain medications. The study is conducted at the Mayo Clinic in Rochester, Minnesota.
Why it matters
Potential benefit: If successful, the findings could help clarify whether whole-fat dairy is safe or beneficial for improving metabolic and vascular risk markers in people with metabolic syndrome, informing dietary guidance.
How similar studies have gone: Previous observational and randomized studies on dairy fat and cardiometabolic outcomes have shown mixed results, so this trial builds on but does not yet settle existing evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Presence of 3 of the following risk factors: 1. fasting plasma glucose ≥100 mg/dL (or medical therapy for elevated glucose) 2. HDL-C \<40 mg/dL in men or \<50 mg/dL in women (or medical therapy for reduced HDL-C) 3. Triglycerides ≥150 mg/dL (or medical therapy for elevated triglycerides) 4. Waist circumference \>102 cm for men and \>88 cm for women 5. Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg (or medical therapy for hypertension) Exclusion Criteria: 1. Cardiovascular disease diagnosis 2. Type 1 or 2 diabetes diagnosis 3. Dairy allergy or lactose intolerance 4. Self-reported high baseline dairy intake (\>3 servings per day) 5. \>3 hours of physical activity per week 6. Pregnant women 7. Inflammatory bowel disease 8. Chronic steroid use 9. Allergy to metal 10. GLP-1 agonist use 11. Patients on medications related to metabolic syndrome where dose adjustments are planned to be made during the study period.
Where it's running
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Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Joshua Smith, PhD — Mayo Clinic
- Study coordinator: Eric Bruhn
- Email: bruhn.eric@mayo.edu
- Phone: 507-266-2690
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.