A Study Of Milk Consumption In Metabolic Syndrome

Milk Consumption On Cardiovascular Risk Factors 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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Other: Full-fat diet; Other: Low-fat diet

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Bruhn; Phone Number: 507-266-2690; Email: bruhn.eric@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Joshua R. Smith, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full-fat diet first then Low-fat diet	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.
Experimental: Low-fat diet first then Full-fat diet	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Cholesterol	Total Cholesterol will be measured by a blood sample and reported as mg/dL	Baseline, Week 3, Week 5, Week 8
Change in HDL-C (High Density Lipoprotein Cholesterol)	High Density Lipoprotein Cholesterol will be measured by a blood sample and reported as mg/dL	Baseline, Week 3, Week 5, Week 8
Change in LDL-C (Low Density Lipoprotein Cholesterol)	Low Density Lipoprotein Cholesterol will be measured by a blood sample and reported as mg/dL	Baseline, Week 3, Week 5, Week 8
Change in Triglycerides	Triglycerides will be measured by a blood sample and reported as mg/dL	Baseline, Week 3, Week 5, Week 8
Change in Blood Glucose	Blood Glucose will be measured by a blood sample and reported as mg/dL	Baseline, Week 3, Week 5, Week 8
Change in Hemoglobin A1c	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.	Baseline, Week 3, Week 5, Week 8
Change in C-reactive protein	C-reactive protein will be measured by a blood sample and reported as mg/L	Baseline, Week 3, Week 5, Week 8
Change in Lipoprotein	Lipoprotein will be measured by a blood sample and reported as mg/dL	Baseline, Week 3, Week 5, Week 8
Change in Macrovascular Function	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	Baseline, Week 3, Week 5, Week 8
Change in Microvascular Function	Quantification of the area under the curve of the brachial artery blood flow following cuff release	Baseline, Week 3, Week 5, Week 8

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Joshua Smith, PhD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Nutritional and Metabolic Diseases; Metabolic Syndrome; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet Therapy; Nutrition Therapy; Diet; Diet, Fat-Restricted
• Other Study ID Numbers: 25-010619

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No