Evaluation of Milk Polar Lipids in Dyslipidemic Adults With Abdominal Obesity

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

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05700916

Enrollment

130

Registered

2023-01-26

Start date

2023-10-20

Completion date

2026-12-31

Last updated

2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias, Obesity

Brief summary

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

Detailed description

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: 1. Determine the effects of MPLs on serum lipid concentrations and other cardiometabolic risk factors. 2. Evaluate the effects of MPLs on systemic biomarkers of low-grade inflammation. 3. Examine the effects of MPLs on lipoprotein metabolism and lipoprotein particle characteristics. 4. Evaluate the effects of MPLs on gut microbiota, gut permeability markers, and fecal lipids.

Interventions

DRUGMilk Polar Lipid-Rich Dairy Powder

Effects of the addition of 6.5 g of milk polar lipids to dairy powder.

DIETARY_SUPPLEMENTDairy Powder

Effects of dairy control powder

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* LDL-C ≥ 130 mg/dL * Waist circumference ≥ 88 cm for women, ≥ 102 cm for men * Aged 18 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 * 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).

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026