Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID07401888

Milk Consumption On Cardiovascular Risk Factors In Metabolic Syndrome

Led by Mayo Clinic · Updated on 2026-04-16

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effects of whole-fat dairy consumption on heart and metabolic health in adults with metabolic syndrome. The study aims to understand how this diet influences cardiovascular risk factors and the function of blood vessels in this group. The research is sponsored by Mayo Clinic and is designed as a randomized, double-blind clinical trial. Participants will follow two different diet plans: a full-fat, isoenergetic diet and a low-fat, isoenergetic diet, each lasting three weeks. Both diets contain 45% carbohydrates, 20% protein, and 35% fat. Participants will switch from one diet to the other during the trial to compare their effects on health markers. During the study, researchers will measure changes in cholesterol levels, blood sugar, inflammatory markers, and vascular function at baseline, week 3, week 5, and week 8. These assessments include total cholesterol, HDL-C, LDL-C, triglycerides, blood glucose, hemoglobin A1c, C-reactive protein, lipoprotein, and both macrovascular and microvascular function. The study will monitor participants closely throughout to evaluate these outcomes and ensure safety.

CONDITIONS

Brief Title

A Study Of Milk Consumption In Metabolic Syndrome

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 70 years
  • Presence of at least three of the following risk factors: fasting plasma glucose 60;100 mg/dL or treatment for high glucose
  • HDL-C below 40 mg/dL in men or below 50 mg/dL in women, or treatment for low HDL-C
  • Triglycerides 60;150 mg/dL or treatment for elevated triglycerides
  • Waist circumference above 102 cm for men and above 88 cm for women
  • Systolic blood pressure 60;130 mmHg or diastolic blood pressure 60;80 mmHg, or treatment for hypertension
Not Eligible

You will not qualify if you...

  • Diagnosis of cardiovascular disease
  • Diagnosis of type 1 or type 2 diabetes
  • Allergy to dairy or lactose intolerance
  • High baseline dairy intake (more than 3 servings per day)
  • More than 3 hours of physical activity per week
  • Pregnancy
  • Inflammatory bowel disease
  • Chronic steroid use
  • Allergy to metal
  • Use of GLP-1 agonist medications
  • Planned dose adjustments for medications related to metabolic syndrome during the study period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Full-fat diet

Duration - 3 weeks

Participants follow a full-fat, isoenergetic diet consisting of 45% carbohydrates, 20% protein, and 35% fat.

Visits at baseline and Week 3

Low-fat diet

Duration - 3 weeks

Participants follow a low-fat, isoenergetic diet consisting of 45% carbohydrates, 20% protein, and 35% fat.

Visits at Week 5 and Week 8

Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

E

Eric Bruhn

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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