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Evaluation of Milk Polar Lipids in Dyslipidemic Adults With Abdominal Obesity

Primary Purpose

Dyslipidemias, Obesity

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Milk Polar Lipid-Rich Dairy Powder
Dairy Powder
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dyslipidemias

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of ConnecticutRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MPL-rich dairy powder

Control dairy powder

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 10, 2023
Last Updated
September 18, 2023
Sponsor
University of Connecticut
Collaborators
Dairy Management Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05700916
Brief Title
Evaluation of Milk Polar Lipids in Dyslipidemic Adults With Abdominal Obesity
Official Title
Evaluation of Milk Polar Lipids on Lipoprotein Metabolism, Inflammation, and Gut Microbiota in Dyslipidemic Adults With Abdominal Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
Collaborators
Dairy Management Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MPL-rich dairy powder
Arm Type
Experimental
Arm Description
Daily consumption of 50 g of dairy powder containing 6.5 g MPL for 8 weeks.
Arm Title
Control dairy powder
Arm Type
Placebo Comparator
Arm Description
Daily consumption of 50 g of dairy powder containing <0.1 g MPL for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Milk Polar Lipid-Rich Dairy Powder
Intervention Description
Effects of the addition of 6.5 g of milk polar lipids to dairy powder.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dairy Powder
Intervention Description
Effects of dairy control powder
Primary Outcome Measure Information:
Title
Change from Baseline Serum LDL Cholesterol at 8 weeks
Description
Measurement of serum LDL cholesterol (mg/dL) at the beginning and end of 8-week intervention arm.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher N Blesso, Ph.D.
Phone
860-486-9049
Email
christopher.blesso@uconn.edu
Facility Information:
Facility Name
University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Blesso, Ph.D.
Email
christopher.blesso@uconn.edu
First Name & Middle Initial & Last Name & Degree
Christopher Blesso, Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Milk Polar Lipids in Dyslipidemic Adults With Abdominal Obesity

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