Recruiting

Whole-Fat Dairy

Sponsor:

Mayo Clinic

Code:

NCT07401888

Conditions

Metabolic Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Full-fat diet

Low-fat diet

Study Details

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

Study ID

NCT07401888

Start date

Apr 13, 2026

Status verified date

Apr, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Full-fat diet first then Low-fat diet

experimental: Low-fat diet first then Full-fat diet

Interventions

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.

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.

Primary outcome measure

  • Change in Total Cholesterol [ Time Frame: Baseline, Week 3, Week 5, Week 8 ]
  • Change in HDL-C (High Density Lipoprotein Cholesterol) [ Time Frame: Baseline, Week 3, Week 5, Week 8 ]
  • Change in LDL-C (Low Density Lipoprotein Cholesterol) [ Time Frame: Baseline, Week 3, Week 5, Week 8 ]
  • Change in Triglycerides [ Time Frame: Baseline, Week 3, Week 5, Week 8 ]
  • Change in Blood Glucose [ Time Frame: Baseline, Week 3, Week 5, Week 8 ]
  • Change in Hemoglobin A1c [ Time Frame: Baseline, Week 3, Week 5, Week 8 ]
  • Change in C-reactive protein [ Time Frame: Baseline, Week 3, Week 5, Week 8 ]
  • Change in Lipoprotein [ Time Frame: Baseline, Week 3, Week 5, Week 8 ]
  • Change in Macrovascular Function [ Time Frame: Baseline, Week 3, Week 5, Week 8 ]
  • Change in Microvascular Function [ Time Frame: Baseline, Week 3, Week 5, Week 8 ]

Central Contacts and Locations

Central contacts

Eric Bruhn

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

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-16.