Serum CholesterolNCT04208815
Evaluation of Dietary Milk Polar Lipids on Serum Cholesterol and Gut Microbiota in Healthy Adults
A study testing Milk Polar Lipids and Milk Fat in people with Serum Cholesterol and Gut Microbiome, run by University of Connecticut at 1 site in United States.
Trial summary
The purpose of this study is to examine whether the daily consumption of 5 g of milk polar lipids influences serum lipids and gut microbiota composition in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Serum Cholesterol, Gut Microbiome
- What is being tested?
- Milk Polar Lipids and Milk Fat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 50 years
- Body Mass Index < 30 kg/m^2
- Willing to consume experimental intervention products on a daily basis
Who cannot join
- Outside of age range (<18 or >50 years old)
- Body Mass Index > 30 kg/m^2
- Triglycerides are higher than 500 mg/dL, glucose levels higher than 126 mg/dL, or total cholesterol higher than 240 mg/dL
- Self-reported history of renal or liver disease, diabetes, thyroid disease, gallbladder disease, eating disorders, heart disease, stroke, cancer and gut-associated pathologies
- Weight loss greater than 10% of body weight over preceding 4 weeks
- Taking probiotic supplements or oral antibiotics up to 1 month prior to the study and during the study
- Allergy to dairy or lactose intolerance
- Taking lipid-lowering medications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
The purpose of this study is to examine whether the daily consumption of 5 g of milk polar lipids influences serum lipids and gut microbiota composition in healthy adults.
Read the detailed description
Healthy adults will be recruited to participate in a randomized, single-blind, controlled, 13-week crossover trial. Participants will follow a 2-week run-in control period consuming their habitual diets. Participants will then be randomized to consume 20 g of milk fat daily in the form of either a reconstituted milk polar lipid (MPL)-rich dairy beverage (MPL; providing 5.3 g MPL daily) or a control dairy beverage (CTL; providing 0.3 g MPL daily), each for 4- weeks, separated by a 3-week washout period. Participants will be instructed to consume intervention treatment/control beverages at breakfast (50 g) and dinner (50 g) and reconstitute the powders in water immediately prior to consumption. With the exception of the intervention beverages, participants will be asked to maintain their normal diet and exercise habits throughout the study. Venous blood will be collected after a 12-hour overnight fast into EDTA-coated (glucose analysis) and serum (lipid analyses) collection tubes. Passive drool and stool samples will be collected at the end of the run-in period (baseline) and intervention periods (treatment and control). Participants will be asked to complete a 5-day dietary record, food preference/liking/sedentary behavior surveys, and 7-day physical activity diary at the beginning and end of intervention periods.
- Conditions
- Serum Cholesterol, Gut Microbiome
- Being tested
- Milk Polar Lipids, Milk Fat
- Keywords
- Milk, Polar Lipids, Phospholipids, Cholesterol, Microbiota, Microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk Polar LipidsOther
Effects of the addition of 5 g of milk polar lipids to 20 g milk fat.
Milk FatOther
Effects of the addition of 20 g milk fat.
| Study group | Role | What they receive |
|---|---|---|
| MPL-rich dairy beverage | Experimental | Daily consumption of 100 g of dairy powder containing 5.3 g MPL for 4 weeks Receives: Other: Milk Polar Lipids; Other: Milk Fat |
| Control dairy beverage | Placebo comparator | Daily consumption of 100 g of dairy powder containing 0.3 g MPL for 4 weeks Receives: Other: Milk Fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Serum Total Cholesterol at 4 weeks
Measurement of serum cholesterol (mg/dL) at the beginning and end of each 4-week intervention arms.
Measured: 4 weeks
Secondary outcomes (1)
Change in Fecal Microbiota Shannon Index at 4 weeks
Measurement of fecal microbiota Shannon Index at the end of each 4-week intervention arms.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start1 Mar 2020
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serum CholesterolStudies 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Blesso, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208815
- Sponsor's protocol ID
- H19-122
- Status last verified
- Jan 2022
- First submitted
- 18 Dec 2019
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dietary Milk Polar Lipids on Serum Cholesterol and Gut Microbiota in Healthy Adults
- ClinicalTrials.gov ID
- NCT04208815
- Acronym / sponsor ID
- H19-122
- Conditions
- Serum Cholesterol, Gut Microbiome
- Keywords
- Milk, Polar Lipids, Phospholipids, Cholesterol, Microbiota, Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 23 Dec 2019 (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 purpose of this study is to examine whether the daily consumption of 5 g of milk polar lipids influences serum lipids and gut microbiota composition in healthy adults.
Detailed description
Healthy adults will be recruited to participate in a randomized, single-blind, controlled, 13-week crossover trial. Participants will follow a 2-week run-in control period consuming their habitual diets. Participants will then be randomized to consume 20 g of milk fat daily in the form of either a reconstituted milk polar lipid (MPL)-rich dairy beverage (MPL; providing 5.3 g MPL daily) or a control dairy beverage (CTL; providing 0.3 g MPL daily), each for 4- weeks, separated by a 3-week washout period. Participants will be instructed to consume intervention treatment/control beverages at breakfast (50 g) and dinner (50 g) and reconstitute the powders in water immediately prior to consumption. With the exception of the intervention beverages, participants will be asked to maintain their normal diet and exercise habits throughout the study. Venous blood will be collected after a 12-hour overnight fast into EDTA-coated (glucose analysis) and serum (lipid analyses) collection tubes. Passive drool and stool samples will be collected at the end of the run-in period (baseline) and intervention periods (treatment and control). Participants will be asked to complete a 5-day dietary record, food preference/liking/sedentary behavior surveys, and 7-day physical activity diary at the beginning and end of intervention periods.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPL-rich dairy beverage | Experimental | Other: Milk Polar Lipids, Other: Milk FatDaily consumption of 100 g of dairy powder containing 5.3 g MPL for 4 weeks |
| Control dairy beverage | Placebo comparator | Other: Milk FatDaily consumption of 100 g of dairy powder containing 0.3 g MPL for 4 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18 to 50 years
- Body Mass Index < 30 kg/m^2
- Willing to consume experimental intervention products on a daily basis
Key exclusion criteria (8 listed)
- Outside of age range (<18 or >50 years old)
- Body Mass Index > 30 kg/m^2
- Triglycerides are higher than 500 mg/dL, glucose levels higher than 126 mg/dL, or total cholesterol higher than 240 mg/dL
- Self-reported history of renal or liver disease, diabetes, thyroid disease, gallbladder disease, eating disorders, heart disease, stroke, cancer and gut-associated pathologies
- Weight loss greater than 10% of body weight over preceding 4 weeks
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 LipidsEffects of the addition of 5 g of milk polar lipids to 20 g milk fat. | Other | MPL-rich dairy beverage |
| Milk FatEffects of the addition of 20 g milk fat. | Other | Control dairy beverage, MPL-rich dairy beverage |
Primary outcome
Change from Baseline Serum Total Cholesterol at 4 weeks
Time frame: 4 weeks
Measurement of serum cholesterol (mg/dL) at the beginning and end of each 4-week intervention arms.
1 secondary outcome
Change in Fecal Microbiota Shannon Index at 4 weeks
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
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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 study testing Milk Polar Lipids and Milk Fat in people with Serum Cholesterol and Gut Microbiome, 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 8 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: finished, as of the sponsor's last update on 13 Jan 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Total Cholesterol at 4 weeks (time frame: 4 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 13 Jan 2022.