Metabolic Syndrome
Conditions
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.
Interventions
OTHERFull-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.
OTHERLow-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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Cholesterol | Baseline, Week 3, Week 5, Week 8 | Total Cholesterol will be measured by a blood sample and reported as mg/dL |
| Change in HDL-C (High Density Lipoprotein Cholesterol) | Baseline, Week 3, Week 5, Week 8 | High Density Lipoprotein Cholesterol will be measured by a blood sample and reported as mg/dL |
| Change in LDL-C (Low Density Lipoprotein Cholesterol) | Baseline, Week 3, Week 5, Week 8 | Low Density Lipoprotein Cholesterol will be measured by a blood sample and reported as mg/dL |
| Change in Triglycerides | Baseline, Week 3, Week 5, Week 8 | Triglycerides will be measured by a blood sample and reported as mg/dL |
| Change in Blood Glucose | Baseline, Week 3, Week 5, Week 8 | Blood Glucose will be measured by a blood sample and reported as mg/dL |
| Change in Hemoglobin A1c | Baseline, Week 3, Week 5, Week 8 | 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. |
| Change in C-reactive protein | Baseline, Week 3, Week 5, Week 8 | C-reactive protein will be measured by a blood sample and reported as mg/L |
| Change in Lipoprotein | Baseline, Week 3, Week 5, Week 8 | Lipoprotein will be measured by a blood sample and reported as mg/dL |
| Change in Macrovascular Function | Baseline, Week 3, Week 5, Week 8 | 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 |
| Change in Microvascular Function | Baseline, Week 3, Week 5, Week 8 | Quantification of the area under the curve of the brachial artery blood flow following cuff release |
Countries
United States
Contacts
CONTACTEric Bruhn
PRINCIPAL_INVESTIGATORJoshua Smith, PhD
Mayo Clinic
Outcome results
None listed