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NCT03376555 · ClinicalTrials.gov registry record · Phase 1
Cheese Consumption and Human Microvascular Function
A Phase 1 study of Microvascular Dysfunction, sponsored by Lacy Alexander.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT03376555: Completed Phase 1 study of Microvascular Dysfunction, sponsored by Lacy Alexander.
NCT03376555 is a Phase 1 study of Microvascular Dysfunction that has completed, run by Lacy Alexander. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03376555, a Phase 1 study of Microvascular Dysfunction, has completed, sponsored by Lacy Alexander.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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)
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Low sodium no cheese
- DIETARY_SUPPLEMENT Low sodium cheese
- DIETARY_SUPPLEMENT High sodium no cheese
- DIETARY_SUPPLEMENT High sodium cheese
Study Locations (1)
Pennsylvania
- Pennsylvania State University - University Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2017-07-01 |
| Est. Completion | 2021-03-01 |
| Phase | Phase 1 |
What the finished NCT03376555 record still lists
NCT03376555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Microvascular Dysfunction appearing as the primary indexed condition, and to 4 interventions - of which Low sodium no cheese is the first listed.
NCT03376555 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03376555 about?
NCT03376555 is a clinical study titled "Cheese Consumption and Human Microvascular Function". 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 so...
What is the current status of trial NCT03376555?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2017-07-01. Estimated completion is 2021-03-01.
What conditions does trial NCT03376555 study?
This clinical trial studies the following conditions: Microvascular Dysfunction.
What interventions are being tested in trial NCT03376555?
The interventions under investigation include: Low sodium no cheese (DIETARY_SUPPLEMENT), Low sodium cheese (DIETARY_SUPPLEMENT), High sodium no cheese (DIETARY_SUPPLEMENT), High sodium cheese (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03376555?
This trial is sponsored by Lacy Alexander, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03376555 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03376555's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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