A Study Of Milk Consumption In Metabolic Syndrome

NCT07401888 | Recruiting

• 1 other identifier: 25-010619
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

Full-fat diet first then Low-fat diet

EXPERIMENTAL

Other: Full-fat diet; Other: Low-fat diet

Low-fat diet first then Full-fat diet

EXPERIMENTAL

Other: Full-fat diet; Other: Low-fat diet

Interventions

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.

Full-fat diet first then Low-fat diet; Low-fat diet first then Full-fat diet

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.

Full-fat diet first then Low-fat diet; Low-fat diet first then Full-fat diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Joshua Smith, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Bruhn

CONTACT

507-266-2690; bruhn.eric@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)