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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Other
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Mayo Clinic in Rochester
Rochester, Minnesota 55905
Contact:
Joshua R. Smith, PhD

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Eric Bruhn
507-266-2690
bruhn.eric@mayo.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.