Evaluation of Milk Polar Lipids in Dyslipidemic Adults With Abdominal Obesity

Study Overview
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Brief Summary
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The major objective of this project is to examine whether daily consumption of milk polar lipids (MPLs) influences cardiometabolic risk factors.

Detailed Description
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The investigators will conduct a randomized, double-blind, controlled, parallel, intervention study in dyslipidemic adults with abdominal obesity (n = 130). Participants will consume either a control dairy beverage (n = 65) or an MPL-rich dairy beverage (n = 65) for 8 weeks. The investigators plan to evaluate the following 4 specific objectives: Determine the effects of MPLs on serum lipid concentrations and other cardiometabolic risk factors. Evaluate the effects of MPLs on systemic biomarkers of low-grade inflammation. Examine the effects of MPLs on lipoprotein metabolism and lipoprotein particle characteristics. Evaluate the effects of MPLs on gut microbiota, gut permeability markers, and fecal lipids.

Official Title
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Evaluation of Milk Polar Lipids on Lipoprotein Metabolism, Inflammation, and Gut Microbiota in Dyslipidemic Adults With Abdominal Obesity

Conditions
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Dyslipidemias, Obesity

Intervention / Treatment
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* Drug: Milk Polar Lipid-Rich Dairy Powder
* Dietary Supplement: Dairy Powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: LDL-C ≥ 130 mg/dL Waist circumference ≥ 88 cm for women, ≥ 102 cm for men Aged 40 to 70 years Exclusion Criteria: Renal disease Liver disease Diabetes Heart disease Stroke Cancer Eating disorders Thyroid disease Gut-associated pathologies Autoimmune diseases Chronic inflammatory diseases Scleroderma Gallbladder disease Blood clotting disorders Intravenous drug use Self-reported pre-menopausal status Fasting plasma/serum triglycerides >500 mg/dL Fasting plasma/serum glucose >126 mg/d Weight changes >10% over last 4 weeks Oral antibiotics use up to 1 month prior to and during study Allergy or intolerance to milk products Taking lipid-lowering medications (e.g., statins, fibrates) Taking anti-inflammatory medications (e.g., corticosteroids) Taking medications which primarily affect blood clotting (e.g., warfarin).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MPL-rich dairy powder<br>Daily consumption of 50 g of dairy powder containing 6.5 g MPL for 8 weeks. | Drug: Milk Polar Lipid-Rich Dairy Powder<br>* Effects of the addition of 6.5 g of milk polar lipids to dairy powder.<br>|
| Placebo Comparator: Control dairy powder<br>Daily consumption of 50 g of dairy powder containing <0.1 g MPL for 8 weeks | Dietary Supplement: Dairy Powder<br>* Effects of dairy control powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Serum LDL Cholesterol at 8 weeks | Measurement of serum LDL cholesterol (mg/dL) at the beginning and end of 8-week intervention arm. | 8 weeks |