Cheese Consumption and Human Microvascular Function

NCT ID: NCT03376555

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2021-03-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Impact of Dairy and Sodium on Microvascular Health

Cross over design with a baseline and 4 dietary interventions

Group Type: EXPERIMENTAL

Low sodium no cheese

Intervention Type: DIETARY_SUPPLEMENT

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

Low sodium cheese

Intervention Type: DIETARY_SUPPLEMENT

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

High sodium no cheese

Intervention Type: DIETARY_SUPPLEMENT

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

High sodium cheese

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Low sodium no cheese

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

Intervention Type: DIETARY_SUPPLEMENT

Low sodium cheese

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

Intervention Type: DIETARY_SUPPLEMENT

High sodium no cheese

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

Intervention Type: DIETARY_SUPPLEMENT

High sodium cheese

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Seated systolic pressure 120-140 mmHg
• Seated diastolic pressure 70-90 mmHg.
• Normoglycemic (HbA1C <5.7%)

Exclusion Criteria

• Taking pharmacotherapy that alters peripheral vascular control
• Pregnancy
• Breastfeeding
• Females taking contraceptives (pills, patches, shots, etc.) or hormone replacement therapy
• Taking illicit and/or recreational drugs
• Use of nicotine containing-products (e.g. smoking, chewing tobacco, etc.)
• Known allergy to latex or investigative substances

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Dairy Council

OTHER

Sponsor Role: collaborator

Lacy Alexander

OTHER

Sponsor Role: lead

Responsible Party

Lacy Alexander

Associate Professor of Kinesiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lacy M Alexander, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Pennsylvania State University

University Park, Pennsylvania, United States

Countries

United States

References

Alba BK, Stanhewicz AE, Dey P, Bruno RS, Kenney WL, Alexander LM. 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. J Nutr. 2020 Jan 1;150(1):55-63. doi: 10.1093/jn/nxz205.

Reference Type: DERIVED

PMID: 31504721 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

129552

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY4340

Identifier Type: -

Identifier Source: org_study_id