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NCT03376555

Cheese Consumption and Human Microvascular Function

Completed Phase 1, PHASE2 Results posted Last updated 4 May 2025
What this trial tests

Phase 1, PHASE2 trial testing Low sodium no cheese in Microvascular Dysfunction in 13 participants. Completed in 1 March 2021.

Timeline
1 July 2017
Primary endpoint
1 March 2021
1 March 2021

Quick facts

Lead sponsorLacy Alexander
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment13
Start date1 July 2017
Primary completion1 March 2021
Estimated completion1 March 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Lacy Alexander

Who can join

Adults 55 to 75, any sex, with Microvascular Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Microvascular Reactivity to Acetylcholine Primary · 1 hour

Skin blood flow is measured with laser Doppler flowmetry (flux units) and normalized to cutaneous vascular conductance by dividing by mean arterial pressure. Log molar increasing concentrations of acetylcholine are perfused and dose response curves are generated. Dose response curves were analyzed to determine the logEC50 (log Molar)

GroupValue95% CI
Baseline-4.90± 0.2
Low Sodium, No Cheese-4.82± 0.20
Low Sodium, Cheese-5.44± 0.20
High Sodium, No Cheese-3.21± 0.55
High Sodium, Cheese-3.21± 0.55
Systolic Blood Pressure Secondary · 8 days

Blood pressure is measured via brachial auscultation manually or with a critical care monitor. The peak blood pressure during a cardiac cycle when the heart contracts.

GroupValue95% CI
Baseline125± 1
Low Sodium, No Cheese122± 2
Low Sodium, Cheese121± 3
High Sodium, No Cheese127± 3
High Sodium, Cheese124± 3
Diastolic Blood Pressure Secondary · 8 days

Blood pressure is measured via brachial auscultation manually or with a critical care monitor. The lowest blood pressure during a cardiac cycle when the heart is between beats.

GroupValue95% CI
Baseline81± 1
Low Sodium, No Cheese75± 1
Low Sodium, Cheese74± 1
High Sodium, No Cheese78± 1
High Sodium, Cheese76± 1
Flow Mediated Dilation Secondary · 8 days

Flow mediated dilation is measured through Doppler ultrasound probe placed at brachial artery.

GroupValue95% CI
Baseline3.78± 0.78
Low Sodium, No Cheese5.07± 0.90
Low Sodium, Cheese4.20± 0.76
High Sodium, No Cheese3.45± 1.04
High Sodium, Cheese5.90± 1.34

Sponsor's own description

Increased dairy intake is associated with improved measures of blood vessel health. Dairy cheese, however, is often high in sodium. Dietary sodium can impair blood vessel function. The researchers examine if and how natural cheese may protect against impairments in blood vessel function caused by sodium. For this study, participants complete four 8-day controlled feeding periods in which they eat cheese (6 oz/day) or no cheese during a low-sodium or high-sodium base-diet. The participants complete baseline experiments while on their normal personal diet and then repeat experiments at the end of each controlled feeding period. In some of our experiments, the researchers use a technique called "microdialysis" (MD). With MD, the researchers perfuse some research drugs into the skin on the forearm through tiny tubing that mimics capillaries. These MD drugs mimic or block substances the body naturally makes to control the small blood vessels in the skin. The drugs remain in nickel-sized areas around the tubing and do not go into the rest of the body. The researchers also use a standard technique called "flow mediated dilation" (FMD) that uses blood pressure cuffs and ultrasound to look at the health of larger blood vessels in the body. FMD includes placing a small tablet of nitroglycerin under the tongue during part of the test.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Controlled Feeding of an 8-d, High-Dairy Cheese Diet Prevents Sodium-Induced Endothelial Dysfunction in the Cutaneous Microcirculation of Healthy, Older Adults through Reductions in Superoxide.
    Alba BK, Stanhewicz AE, Dey P, Bruno RS, et al · · 2020 · cited 12× · PMID 31504721 · DOI 10.1093/jn/nxz205
  2. AHA/ACC-defined stage 1 hypertensive adults do not display cutaneous microvascular endothelial dysfunction.
    Dillon GA, Greaney JL, Shank S, Leuenberger UA, et al · · 2020 · cited 9× · PMID 32734817 · DOI 10.1152/ajpheart.00179.2020
  3. Precision Medicine: Therapeutically Targeting Mitochondrial Alterations in Heart Failure.
    Parker AM, Lees JG, Murray AJ, Velagic A, et al · · 2025 · cited 5× · PMID 40845481 · DOI 10.1016/j.jacbts.2025.101345

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing