Recruiting NCT07401888
A Study Of Milk Consumption In Metabolic Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Full-fat diet, Low-fat diet.
- Who it may be relevant to
- Registry conditions: Metabolic Syndrome. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Milk Consumption On Cardiovascular Risk Factors In Metabolic Syndrome
Overview
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
- 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.
Primary outcome measures
- 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]
Eligibility criteria
Inclusion Criteria: Presence of 3 of the following risk factors:
- fasting plasma glucose ≥100 mg/dL (or medical therapy for elevated glucose)
- HDL-C <40 mg/dL in men or <50 mg/dL in women (or medical therapy for reduced HDL-C)
- Triglycerides ≥150 mg/dL (or medical therapy for elevated triglycerides)
- Waist circumference >102 cm for men and >88 cm for women
- Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg (or medical therapy for hypertension)
Exclusion criteria
- Cardiovascular disease diagnosis
- Type 1 or 2 diabetes diagnosis
- Dairy allergy or lactose intolerance
- Self-reported high baseline dairy intake (>3 servings per day)
- >3 hours of physical activity per week
- Pregnant women
- Inflammatory bowel disease
- Chronic steroid use
- Allergy to metal
- GLP-1 agonist use
- Patients on medications related to metabolic syndrome where dose adjustments are planned to be made during the study period.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07401888 · 25-010619