NCT05700916

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for early_phase_1

Timeline
1mo left

Started Oct 2023

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Oct 2023Jun 2026

First Submitted

Initial submission to the registry

January 10, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

2.5 years

First QC Date

January 10, 2023

Last Update Submit

December 15, 2025

Conditions

DyslipidemiasObesity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

MPL-rich dairy powder

EXPERIMENTAL

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

Drug: Milk Polar Lipid-Rich Dairy Powder

Control dairy powder

PLACEBO COMPARATOR

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

Dietary Supplement: Dairy Powder

Interventions

Milk Polar Lipid-Rich Dairy PowderDRUG

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

MPL-rich dairy powder
Dairy PowderDIETARY_SUPPLEMENT

Effects of dairy control powder

Control dairy powder

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LDL-C ≥ 130 mg/dL
  • Waist circumference ≥ 88 cm for women, ≥ 102 cm for men
  • Aged 18 to 70 years

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

RECRUITING

MeSH Terms

Conditions

DyslipidemiasObesity

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Christopher N Blesso, Ph.D.

CONTACT

860-486-9049christopher.blesso@uconn.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 26, 2023

Study Start

October 20, 2023

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations

US(1)