CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Low sodium no cheese +3 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03376555
NCT03376555Phase 2Completed

Cheese Consumption and Human Microvascular Function

Lacy Alexander·interventional·Posted Dec 18, 2017·Updated May 4, 2025

In Brief

A Phase 2 clinical trial evaluating Low sodium no cheese, Low sodium cheese, and 2 other interventions for Microvascular Dysfunction. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 18, 2017
Enrollment StartJul 1, 2017
Primary CompletionMar 1, 2021
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 8.5 years ago

Interventions

Low sodium no cheesedietary

Diet contains 1,500 mg sodium per day Diet does not contain dairy cheese 8 days

Low sodium cheesedietary

Diet contains 1,500 mg sodium per day Diet contains 6 oz dairy cheese per day 8 days

High sodium no cheesedietary

Diet contains 5,500 mg sodium per day Diet does not contain dairy cheese 8 days

High sodium cheesedietary

Diet contains 5,500 mg sodium per day Diet contains 6 oz dairy cheese per day 8 days