DyslipidemiasEarly Phase 1NCT05700916
Evaluation of Milk Polar Lipids in Dyslipidemic Adults With Abdominal Obesity
A Early Phase 1 study testing Milk Polar Lipid-Rich Dairy Powder and Dairy Powder in people with Dyslipidemias and Obesity, run by University of Connecticut at 1 site in United States.
Trial summary
The major objective of this project is to examine whether daily consumption of milk polar lipids (MPLs) influences cardiometabolic risk factors. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Obesity
- What is being tested?
- Milk Polar Lipid-Rich Dairy Powder and Dairy Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2023to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- LDL-C ≥ 130 mg/dL
- Waist circumference ≥ 88 cm for women, ≥ 102 cm for men
- Aged 18 to 70 years
Who cannot join
- Renal disease
- Liver disease
- Diabetes
- Heart disease
- Stroke
- Cancer
Show all 23Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
Official title: Evaluation of Milk Polar Lipids on Lipoprotein Metabolism, Inflammation, and Gut Microbiota in Dyslipidemic Adults With Abdominal Obesity
The major objective of this project is to examine whether daily consumption of milk polar lipids (MPLs) influences cardiometabolic risk factors.
Read the 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.
- Conditions
- Dyslipidemias, Obesity
- Being tested
- Milk Polar Lipid-Rich Dairy Powder, Dairy Powder
- Medical subject headings
- Dyslipidemias, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk Polar Lipid-Rich Dairy PowderDrug
Effects of the addition of 6.5 g of milk polar lipids to dairy powder.
Dairy PowderDietary supplement
Effects of dairy control powder
| Study group | Role | What they receive |
|---|---|---|
| MPL-rich dairy powder | Experimental | Daily consumption of 50 g of dairy powder containing 6.5 g MPL for 8 weeks. Receives: 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 Receives: Dietary Supplement: Dairy Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start20 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Management Inc.
- Responsible party
- Principal investigator, Christopher Blesso, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700916
- Sponsor's protocol ID
- H22-0161
- Status last verified
- Aug 2026
- First submitted
- 10 Jan 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Milk Polar Lipids on Lipoprotein Metabolism, Inflammation, and Gut Microbiota in Dyslipidemic Adults With Abdominal Obesity
- ClinicalTrials.gov ID
- NCT05700916
- Acronym / sponsor ID
- H22-0161
- Conditions
- Dyslipidemias, Obesity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- Dairy Management Inc.
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPL-rich dairy powder | Experimental | Drug: Milk Polar Lipid-Rich Dairy PowderDaily consumption of 50 g of dairy powder containing 6.5 g MPL for 8 weeks. |
| Control dairy powder | Placebo comparator | Dietary Supplement: Dairy PowderDaily consumption of 50 g of dairy powder containing <0.1 g MPL for 8 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- LDL-C ≥ 130 mg/dL
- Waist circumference ≥ 88 cm for women, ≥ 102 cm for men
- Aged 18 to 70 years
Key exclusion criteria (23 listed)
- Renal disease
- Liver disease
- Diabetes
- Heart disease
- Stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk Polar Lipid-Rich Dairy PowderEffects of the addition of 6.5 g of milk polar lipids to dairy powder. | Drug | MPL-rich dairy powder |
| Dairy PowderEffects of dairy control powder | Dietary supplement | Control dairy powder |
Primary outcome
Change from Baseline Serum LDL Cholesterol at 8 weeks
Time frame: 8 weeks
Measurement of serum LDL cholesterol (mg/dL) at the beginning and end of 8-week intervention arm.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Milk Polar Lipid-Rich Dairy Powder and Dairy Powder in people with Dyslipidemias and Obesity, run by University of Connecticut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Serum LDL Cholesterol at 8 weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.