A Study Of Milk Consumption In Metabolic Syndrome

Mayo Clinic

Status: Not yet enrolling

Conditions: Metabolic Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07401888

25-010619

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Full-fat diet first then Low-fat diet

Experimental group

Treatment:

Other: Low-fat diet

Other: Full-fat diet

Low-fat diet first then Full-fat diet

Experimental group

Treatment:

Other: Low-fat diet

Other: Full-fat diet