NCT03376555

Cheese Consumption and Human Microvascular Function

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Lacy Alexander · Academic / Other
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

Subject screening will be performed by the Penn State Clinical Translational Research Center (CTRC) medical staff and will include a physical exam by a clinician, anthropometry, and a chemical and lipid profile, liver and renal function. Participants meet with a registered dietitian to determine their caloric energy requirements and identify food preferences. The interview includes surveying the subject's physical activity over the previous 7 days. Subjects will undergo baseline microdialysis experiments to examine the function of the blood vessels in the skin microcirculation. Subjects will also go through a baseline assessment of conduit vessel endothelial and vascular smooth muscle function with brachial artery flow-mediated vasodilation (FMD), and sublingual nitroglycerin. Following baseline experiments, subjects participate in 4 controlled feeding periods, each 8 days in duration. The controlled feeding periods are assigned in a randomized order. At the end of each 8-day controlled dietary period, subjects will repeat microdialysis experiments, brachial artery FMD, and responsiveness to sublingual nitroglycerin.

Conditions

• Microvascular Dysfunction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Low sodium no cheese	Diet contains 1,500 mg sodium per day Diet does not contain dairy cheese 8 days
DIETARY_SUPPLEMENT	Low sodium cheese	Diet contains 1,500 mg sodium per day Diet contains 6 oz dairy cheese per day 8 days
DIETARY_SUPPLEMENT	High sodium no cheese	Diet contains 5,500 mg sodium per day Diet does not contain dairy cheese 8 days
DIETARY_SUPPLEMENT	High sodium cheese	Diet contains 5,500 mg sodium per day Diet contains 6 oz dairy cheese per day 8 days

Timeline

• Start date: 2017-07-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2017-12-18
• Last updated: 2025-05-04
• Results posted: 2025-05-04

Locations

1 site across 1 country: United States