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NCT Number: NCT07401888

A Study Of Milk Consumption In Metabolic Syndrome

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.

Recruiting

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Joshua R. Smith, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Full-fat diet

Other

The patients will follow a full-fat, isoenergetic diet consisting of 45% carbohydrates, 20% protein, and 35% fat for a duration of three weeks.

Low-Fat Diet

Other

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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Bruhn

CONTACT

[email protected]

507-266-2690

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Milk Consumption On Cardiovascular Risk Factors In Metabolic Syndrome

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 11, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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