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Evaluation of Milk Polar Lipids in Dyslipidemic Adults With Abdominal Obesity

NCT ID: NCT05700916

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-20

Study Completion Date

2026-06-30

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:

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.

Conditions

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Dyslipidemias Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MPL-rich dairy powder

Daily consumption of 50 g of dairy powder containing 6.5 g MPL for 8 weeks.

Group Type EXPERIMENTAL

Milk Polar Lipid-Rich Dairy Powder

Intervention Type DRUG

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

Control dairy powder

Daily consumption of 50 g of dairy powder containing \<0.1 g MPL for 8 weeks

Group Type PLACEBO_COMPARATOR

Dairy Powder

Intervention Type DIETARY_SUPPLEMENT

Effects of dairy control powder

Interventions

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Milk Polar Lipid-Rich Dairy Powder

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

Intervention Type DRUG

Dairy Powder

Effects of dairy control powder

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dairy Management Inc.

INDUSTRY

Sponsor Role collaborator

University of Connecticut

OTHER

Sponsor Role lead

Responsible Party

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Christopher Blesso

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Connecticut

Storrs, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christopher N Blesso, Ph.D.

Role: CONTACT

Phone: 860-486-9049

Email: [email protected]

Facility Contacts

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Christopher Blesso, Ph.D.

Role: primary

Other Identifiers

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H22-0161

Identifier Type: -

Identifier Source: org_study_id