Metabolic SyndromeNCT07401888
A Study Of Milk Consumption In Metabolic Syndrome
A study testing Full-fat diet and Low-fat diet in people with Metabolic Syndrome, run by Mayo Clinic at 1 site in United States.
Trial summary
The primary purpose of this study is to determine the impact of whole-fat dairy consumption on cardiovascular and metabolic risk factors and peripheral vascular function in adults with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Full-fat diet and Low-fat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2026to Feb 2028
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Cardiovascular disease diagnosis
- Type 1 or 2 diabetes diagnosis
- Dairy allergy or lactose intolerance
- Self-reported high baseline dairy intake (>3 servings per day)
- >3 hours of physical activity per week
- Pregnant women
Show all 11Show fewer
- Inflammatory bowel disease
- Chronic steroid use
- Allergy to metal
- GLP-1 agonist use
- Patients on medications related to metabolic syndrome where dose adjustments are planned to be made during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Joshua R. Smith, PhD
About this study
Official title: Milk Consumption On Cardiovascular Risk Factors In Metabolic Syndrome
The primary purpose of this study is to determine the impact of whole-fat dairy consumption on cardiovascular and metabolic risk factors and peripheral vascular function in adults with metabolic syndrome.
- Conditions
- Metabolic Syndrome
- Being tested
- Full-fat diet, Low-fat diet
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-fat dietOther
The patients will follow a full-fat, isoenergetic diet consisting of 45% carbohydrates, 20% protein, and 35% fat for a duration of three weeks.
Low-fat dietOther
The patients will follow a low-fat, isoenergetic diet consisting of 45% carbohydrates, 20% protein, and 35% fat for a duration of three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Full-fat diet first then Low-fat diet | Experimental | Not described Receives: Other: Full-fat diet; Other: Low-fat diet |
| Low-fat diet first then Full-fat diet | Experimental | Not described Receives: Other: Full-fat diet; Other: Low-fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Cholesterol
Total Cholesterol will be measured by a blood sample and reported as mg/dL
Measured: Baseline, Week 3, Week 5, Week 8
Change in HDL-C (High Density Lipoprotein Cholesterol)
High Density Lipoprotein Cholesterol will be measured by a blood sample and reported as mg/dL
Measured: Baseline, Week 3, Week 5, Week 8
Change in LDL-C (Low Density Lipoprotein Cholesterol)
Low Density Lipoprotein Cholesterol will be measured by a blood sample and reported as mg/dL
Measured: Baseline, Week 3, Week 5, Week 8
Change in Triglycerides
Triglycerides will be measured by a blood sample and reported as mg/dL
Measured: Baseline, Week 3, Week 5, Week 8
Change in Blood Glucose
Blood Glucose will be measured by a blood sample and reported as mg/dL
Measured: Baseline, Week 3, Week 5, Week 8
Change in Hemoglobin A1c
Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin.
Measured: Baseline, Week 3, Week 5, Week 8
Change in C-reactive protein
C-reactive protein will be measured by a blood sample and reported as mg/L
Measured: Baseline, Week 3, Week 5, Week 8
Change in Lipoprotein
Lipoprotein will be measured by a blood sample and reported as mg/dL
Measured: Baseline, Week 3, Week 5, Week 8
Change in Macrovascular Function
Peripheral macrovascular function is the maximal percent change in brachial artery following cuff release and will be assessed via flow-mediated dilation and reported as a percentage
Measured: Baseline, Week 3, Week 5, Week 8
Change in Microvascular Function
Quantification of the area under the curve of the brachial artery blood flow following cuff release
Measured: Baseline, Week 3, Week 5, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start13 Apr 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua R. Smith, Mayo Clinic
- Investigators
- Joshua Smith, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401888
- Sponsor's protocol ID
- 25-010619
- Status last verified
- Apr 2026
- First submitted
- 4 Feb 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milk Consumption On Cardiovascular Risk Factors In Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT07401888
- Acronym / sponsor ID
- 25-010619
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 11 Feb 2026 (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 primary purpose of this study is to determine the impact of whole-fat dairy consumption on cardiovascular and metabolic risk factors and peripheral vascular function in adults with metabolic syndrome.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full-fat diet first then Low-fat diet | Experimental | Other: Full-fat diet, Other: Low-fat diet |
| Low-fat diet first then Full-fat diet | Experimental | Other: Full-fat diet, Other: Low-fat diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Cardiovascular disease diagnosis
- Type 1 or 2 diabetes diagnosis
- Dairy allergy or lactose intolerance
- Self-reported high baseline dairy intake (>3 servings per day)
- >3 hours of physical activity per week
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 |
|---|---|---|
| Full-fat dietThe patients will follow a full-fat, isoenergetic diet consisting of 45% carbohydrates, 20% protein, and 35% fat for a duration of three weeks. | Other | Full-fat diet first then Low-fat diet, Low-fat diet first then Full-fat diet |
| Low-fat dietThe patients will follow a low-fat, isoenergetic diet consisting of 45% carbohydrates, 20% protein, and 35% fat for a duration of three weeks. | Other | Full-fat diet first then Low-fat diet, Low-fat diet first then Full-fat diet |
Primary outcome
Change in Total Cholesterol
Time frame: Baseline, Week 3, Week 5, Week 8
Total Cholesterol will be measured by a blood sample and reported as mg/dL
Change in HDL-C (High Density Lipoprotein Cholesterol)
Time frame: Baseline, Week 3, Week 5, Week 8
High Density Lipoprotein Cholesterol will be measured by a blood sample and reported as mg/dL
Change in LDL-C (Low Density Lipoprotein Cholesterol)
Time frame: Baseline, Week 3, Week 5, Week 8
Low Density Lipoprotein Cholesterol will be measured by a blood sample and reported as mg/dL
Change in Triglycerides
Time frame: Baseline, Week 3, Week 5, Week 8
Triglycerides will be measured by a blood sample and reported as mg/dL
Change in Blood Glucose
Time frame: Baseline, Week 3, Week 5, Week 8
Blood Glucose will be measured by a blood sample and reported as mg/dL
Change in Hemoglobin A1c
Time frame: Baseline, Week 3, Week 5, Week 8
Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin.
Change in C-reactive protein
Time frame: Baseline, Week 3, Week 5, Week 8
C-reactive protein will be measured by a blood sample and reported as mg/L
Change in Lipoprotein
Time frame: Baseline, Week 3, Week 5, Week 8
Lipoprotein will be measured by a blood sample and reported as mg/dL
Change in Macrovascular Function
Time frame: Baseline, Week 3, Week 5, Week 8
Peripheral macrovascular function is the maximal percent change in brachial artery following cuff release and will be assessed via flow-mediated dilation and reported as a percentage
Change in Microvascular Function
Time frame: Baseline, Week 3, Week 5, Week 8
Quantification of the area under the curve of the brachial artery blood flow following cuff release
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 16 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Joshua Smith, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full-fat diet and Low-fat diet in people with Metabolic Syndrome, run by Mayo Clinic 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 0 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 16 Apr 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. 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?
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?
Contact Eric Bruhn (507-266-2690, bruhn.eric@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Cholesterol (time frame: Baseline, Week 3, Week 5, Week 8). The study lists 10 primary outcomes in all. 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 16 Apr 2026.